Common ColdPhase 4NCT06716645

A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin

A Phase 4 study testing Robitussin Maximum Strength Cough and Chest Congestion DM and Robitussin Maximum Strength Nighttime Cough DM in people with Common Cold and Cough, run by HALEON at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this Real-World Evidence study is to generate real world data from participants with cough associated with the common cold, evaluating the effects in two arms with commercially available cough syrups on health-related quality of life (QoL). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Common Cold, Cough
What is being tested?: Robitussin Maximum Strength Cough and Chest Congestion DM and Robitussin Maximum Strength Nighttime Cough DM
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 244 participants
Where: 1 siteUnited States
Study dates: 4 Dec 2024to 14 Feb 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant provides a signed and dated electronic informed consent document indicating that the participant has been informed of and consents to all pertinent aspects of the study, before any assessment is performed and participant has reviewed and is willing to follow the product label.
Participant aged 18 years or older at the time of electronic consent, inclusive of all ethnicities, races and gender identities.
Participant reporting initiation of cough symptoms within 48 hours prior to initiation of the virtual visit.
Participant reporting a minimum score of 5 (moderate) for cough associated with common cold symptoms and at least one other symptom of common cold (at least mild score of 3) as per the WURSS-21 symptom domains.
Participant reporting at least one night's sleep has been disrupted in the previous 2 nights due to the symptoms of common cold.
Participant who is willing to self-treat their cough using the study treatment.

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Participant who is in good general and mental health.
Participant who resides in the United States (except for Hawaii and Alaska).
Participant who owns a mobile device with access to stable internet connection and is willing to use their device to complete study surveys and assessments per the schedule of events.
Participant who has not taken any cough products containing dextromethorphan, guaifenesin, or doxylamine (example, Robitussin, Delsym, Vicks, Mucinex), or cough drops/lozenges containing benzocaine or menthol (example, Cepacol, Halls, Ricola) or any natural cough products during the study.

Who cannot join

Have a history of allergies (example, rash, hives, difficulty breathing, swelling of face, lips, tongue, or throat) to any medication or any kind or sensitivity to ingredients in pain, cough, cold, and flu products; including the following active ingredients found in the Research products:
Active Ingredients - dextromethorphan, guaifenesin, doxylamine.
Inactive Ingredients - anhydrous citric acid, carboxymethylcellulose sodium, FD\&C blue no. 1, FD\&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum.
Participant who is currently taking medications that may interact with the study products.
Participant who is pregnant, lactating, or plans to be pregnant or lactating during the course of the study (self-report).
Participant who has taken any cough products containing dextromethorphan, guaifenesin, or doxylamine (example, Robitussin, Delsym, Vicks, Mucinex), or cough drops/lozenges containing benzocaine or menthol (example, Cepacol, Halls, Ricola) or any natural cough products within 7 days prior to the virtual visit.

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Have previously been diagnosed with:
prostate gland enlargement or difficulty urinating.
glaucoma (excessive pressure inside your eyes).
asthma, chronic bronchitis, chronic cough or chronic lung disease (difficulty in breathing and cough that won't go away).
Pneumonia (within the last 6 months).
Coronavirus disease (COVID-19) (within the last month).
Are taking medication(s) to treat - psychiatric / mental health conditions (example, anxiety, depression) or Parkinson's disease. Medications such as:
1. Monoamine oxidase inhibitor (MAOI) [example, Azilect, Emsam, Marplan, Nardil] or have stopped them within the last 2 weeks per their doctor's advice.
Are currently taking sedatives or tranquilizers (example, Ambien, Xanax, Klonopin).
Are taking drugs for heart problems such as quinidine, amiodarone or metoprolol, antidepressants such as fluoxetine and paroxetine, or antipsychotics such as haloperidol and thioridazine.
Participant who is currently experiencing:
cough accompanied by fever, rash, or persistent headache OR
cough with too much phlegm.
Participant who is an employee of Lindus Health, either directly involved in the conduct of the study or a member of their immediate family; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry.
Participant who has previously been enrolled in this study.
Participant sharing the same address as another participant who has been enrolled in this study.
Participant who, in the opinion of the investigator or delegate, should not participate in the study, including a participant who meets any of the "stop use" criteria recommended by the label.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lindus Health Limited
New York, New York, 10017

Other trials in United States

About this study

Official title: A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin

Read the detailed description

This is a longitudinal, randomized, decentralized, open-label study evaluating the effect on QoL factors in participants with cough associated with the common cold in two arms using Robitussin Maximum Strength in a real-world setting. A sufficient number of adult participants (approximately 372) with symptoms of common cold will be screened for eligibility. The study expects to enroll approximately 260 eligible participants with a total of 200 participants expected to complete the study, approximately 100 in each study group. Participants will be randomized into one of two study groups (at a 1:1 ratio). Participants will be recruited through targeted advertising on social media channels and participants will not be required to physically attend any on-site visits.

Conditions: Common Cold, Cough
Being tested: Robitussin Maximum Strength Cough and Chest Congestion DM, Robitussin Maximum Strength Nighttime Cough DM
Medical subject headings: Common Cold, Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Robitussin Maximum Strength Cough and Chest Congestion DMDrug
Dextromethorphan Hydrobromide, United States Pharmacopeia (USP) 20 milligram (mg) and Guaifenesin, USP 400 mg
Robitussin Maximum Strength Cough and Chest Congestion DMDrug
Dextromethorphan Hydrobromide, USP 20 mg and Guaifenesin, USP 400 mg
Robitussin Maximum Strength Nighttime Cough DMDrug
Dextromethorphan Hydrobromide, USP 30 mg and Doxylamine Succinate, USP 12.5 mg

Study groups in NCT06716645
Study group	Role	What they receive
Robitussin Cough Syrup (Daytime)	Experimental	Participants will be instructed to take up to 20 milliliters (ml) of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurs first. Receives: Drug: Robitussin Maximum Strength Cough and Chest Congestion DM
Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime)	Experimental	Participants will be instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup and up to 20 ml of Robitussin Maximum Strength Nighttime Cough DM syrup orally (not to exceed 4 doses of daytime + 1 dose of nighttime or 3 doses of daytime + 2 doses of nighttime in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurs first. Receives: Drug: Robitussin Maximum Strength Cough and Chest Congestion DM; Drug: Robitussin Maximum Strength Nighttime Cough DM

What is being measured

The primary outcome is the main question the study is designed to answer.

Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score
The WURSS was an evaluative illness-specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. Participants rated their cold symptoms (10 questions) and Quality of Life (QoL) related 9 questions using WURSS-21. The responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms/Not at all and 7=Severe symptoms/Severely. Thus, the minimum and maximum possible total scores were 0 and 133 respectively, where higher total scores indicated more negative impact on symptoms and quality of life. Change from Baseline was calculated as each post-Baseline value minus Baseline value. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information).
Measured: Baseline and up to Day 7 or End of Treatment (EOT)
Adjusted Mean Change From Baseline in WURSS-21 Total Symptom Domain Score
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severe. Thus, the minimum and maximum possible total score was 0 and 70 respectively, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Adjusted Mean Change From Baseline in WURSS-21 Total QoL Domain Score
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 63 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Cough
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Runny Nose
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Plugged Nose
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sneezing
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sore Throat
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Scratchy Throat
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Hoarseness
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms include runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Head Congestion
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Chest Congestion
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Feeling Tired
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Think Clearly
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Sleep Well
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicate more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Breathe Easily
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Walk, Climb Stairs, Exercise
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Accomplish Daily Activities
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Outside the Home
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Inside the Home
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Interact With Others
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Live Your Personal Life
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT

Secondary outcomes (11)

Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Social Activities
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Self-conscious Around People
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Coughing in Public
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Falling Asleep
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Sleeping Through the Night
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Energy
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Motivation
QoL factors were assessed using specific questions related to social activities, feeling self-conscious around people, coughing in public, falling asleep, sleeping through the night, energy, and motivation. Participants rated their response to questions on a scale ranging from 0 to 7, where 0= Not at all and 7= Severely. Thus, the minimum and maximum score for each question was 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Sleep Quality
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Sleep quality category included 3 individual questions - Sleep well (WURSS-21: Question 13), Falling asleep (QoL: Question 4) and Sleep through the night (QoL: Question 5). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total scores was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Vitality
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Vitality category was assessed using 3 individual questions - Energy (QoL: Question 6), Motivation (QoL: Question 7), and Feel tired (WURSS-21: Question 11). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Physical Activities
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Physical Activities were assessed using 3 individual questions - Breathe easily (WURSS-21: Question 14), Walk, climb stairs, exercise (WURSS-21: Question 15) and Accomplish daily activities (WURSS-21: Question 16). Participants rated each question, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 21 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Social Activities
The QoL factors were categorized into 4 categories - Sleep quality, Vitality, Physical activity and Social activity. Social Activities were assessed using 4 individual questions - Interact with others (WURSS-21: Question 19), Less comfortable in social activities (QoL: Question 1), Self-conscious around others (QoL: Question 2) and Coughing in public (QoL: Question 3). Participants rated each question and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. The individual question score was added to derive categorized QoL score. Thus, the minimum and maximum possible total score was 0 and 28 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Measured: Baseline and up to Day 7 or EOT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 202414 Feb 2025

First posted4 Dec 2024
Study start4 Dec 2024
Primary completion14 Feb 2025
Study completion14 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Common ColdStudies of the same condition, open and under way.
More trials run by HALEONThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 244 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06716645
Sponsor's protocol ID: 300233
Status last verified: Feb 2026
First submitted: 29 Nov 2024
Last updated: 20 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

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What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin
ClinicalTrials.gov ID: NCT06716645
Acronym / sponsor ID: 300233
Conditions: Common Cold, Cough
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 244 participants (actual)
Lead sponsor: HALEONIndustry (pharma, biotech, devices)
Study start: 4 Dec 2024 (actual)
Primary completion: 14 Feb 2025 (actual)
Study completion: 14 Feb 2025 (actual)
First posted: 4 Dec 2024 (actual)
Results: Posted 20 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Robitussin Cough Syrup (Daytime)	Experimental	Drug: Robitussin Maximum Strength Cough and Chest Congestion DMParticipants will be instructed to take up to 20 milliliters (ml) of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurs first.
Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime)	Experimental	Drug: Robitussin Maximum Strength Cough and Chest Congestion DM, Drug: Robitussin Maximum Strength Nighttime Cough DMParticipants will be instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup and up to 20 ml of Robitussin Maximum Strength Nighttime Cough DM syrup orally (not to exceed 4 doses of daytime + 1 dose of nighttime or 3 doses of daytime + 2 doses of nighttime in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurs first.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Participant provides a signed and dated electronic informed consent document indicating that the participant has been informed of and consents to all pertinent aspects of the study, before any assessment is performed and participant has reviewed and is willing to follow the product label.
Participant aged 18 years or older at the time of electronic consent, inclusive of all ethnicities, races and gender identities.
Participant reporting initiation of cough symptoms within 48 hours prior to initiation of the virtual visit.
Participant reporting a minimum score of 5 (moderate) for cough associated with common cold symptoms and at least one other symptom of common cold (at least mild score of 3) as per the WURSS-21 symptom domains.
Participant reporting at least one night's sleep has been disrupted in the previous 2 nights due to the symptoms of common cold.

Key exclusion criteria (24 listed)

Have a history of allergies (example, rash, hives, difficulty breathing, swelling of face, lips, tongue, or throat) to any medication or any kind or sensitivity to ingredients in pain, cough, cold, and flu products; including the following active ingredients found in the Research products:
Participant who is currently taking medications that may interact with the study products.
Participant who is pregnant, lactating, or plans to be pregnant or lactating during the course of the study (self-report).
Participant who has taken any cough products containing dextromethorphan, guaifenesin, or doxylamine (example, Robitussin, Delsym, Vicks, Mucinex), or cough drops/lozenges containing benzocaine or menthol (example, Cepacol, Halls, Ricola) or any natural cough products within 7 days prior to the virtual visit.
Have previously been diagnosed with:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Robitussin Maximum Strength Cough and Chest Congestion DMDextromethorphan Hydrobromide, United States Pharmacopeia (USP) 20 milligram (mg) and Guaifenesin, USP 400 mg	Drug	Robitussin Cough Syrup (Daytime)
Robitussin Maximum Strength Cough and Chest Congestion DMDextromethorphan Hydrobromide, USP 20 mg and Guaifenesin, USP 400 mg	Drug	Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime)
Robitussin Maximum Strength Nighttime Cough DMDextromethorphan Hydrobromide, USP 30 mg and Doxylamine Succinate, USP 12.5 mg	Drug	Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime)

Primary outcome

Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score
Time frame: Baseline and up to Day 7 or End of Treatment (EOT)
The WURSS was an evaluative illness-specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. Participants rated their cold symptoms (10 questions) and Quality of Life (QoL) related 9 questions using WURSS-21. The responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms/Not at all and 7=Severe symptoms/Severely. Thus, the minimum and maximum possible total scores were 0 and 133 respectively, where higher total scores indicated more negative impact on symptoms and quality of life. Change from Baseline was calculated as each post-Baseline value minus Baseline value. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information).
Adjusted Mean Change From Baseline in WURSS-21 Total Symptom Domain Score
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severe. Thus, the minimum and maximum possible total score was 0 and 70 respectively, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Adjusted Mean Change From Baseline in WURSS-21 Total QoL Domain Score
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 63 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Cough
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Runny Nose
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Plugged Nose
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sneezing
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sore Throat
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Scratchy Throat
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Hoarseness
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms include runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Head Congestion
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Chest Congestion
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Feeling Tired
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Think Clearly
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Sleep Well
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicate more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Breathe Easily
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Walk, Climb Stairs, Exercise
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Accomplish Daily Activities
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Outside the Home
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Inside the Home
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Interact With Others
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.
Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Live Your Personal Life
Time frame: Baseline and up to Day 7 or EOT
The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

11 secondary outcomes

Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Social Activities
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Self-conscious Around People
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Coughing in Public
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Falling Asleep
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Sleeping Through the Night
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Energy
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Motivation
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Sleep Quality
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Vitality
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Physical Activities
Time frame: Baseline and up to Day 7 or EOT
Mean Change From Baseline in Categorized QoL Questions Score: Social Activities
Time frame: Baseline and up to Day 7 or EOT

Results and safety

Results posted to the registry on 20 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Robitussin Cough Syrup (Daytime)	122	110
Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime)	122	109

Primary outcome: Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score

Time frame: Baseline and up to Day 7 or End of Treatment (EOT). Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Robitussin Cough Syrup (Daytime) n = 111	Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) n = 111
Day 1	-9.56 (-14.45 to -4.66)	-9.11 (-13.49 to -4.73)
Day 2	-26.49 (-31.51 to -21.47)	-22.97 (-27.43 to -18.51)
Day 3	-40.99 (-46.09 to -35.89)	-36.71 (-41.28 to -32.14)
Day 4	-47.63 (-53.07 to -42.18)	-47.20 (-52.00 to -42.40)
Day 5	-51.20 (-57.14 to -45.25)	-55.05 (-60.13 to -49.96)
Day 6	-58.29 (-64.83 to -51.75)	-64.12 (-69.53 to -58.72)
Day 7	-61.58 (-69.87 to -53.30)	-64.69 (-72.62 to -56.76)
EOT	-55.64 (-60.25 to -51.03)	-53.62 (-57.70 to -49.55)

Population analysed: The modified Intent-To-Treat (mITT) population included all participants who used study product at least once and had data from at least one post baseline QoL questionnaire to support at least one of the primary endpoint assessments. Only those participants with data available at the specified timepoint were analyzed.

Primary outcome: Adjusted Mean Change From Baseline in WURSS-21 Total Symptom Domain Score

Time frame: Baseline and up to Day 7 or EOT. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Robitussin Cough Syrup (Daytime) n = 111	Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) n = 111
Day 1	-6.48 (-9.00 to -3.95)	-5.89 (-8.27 to -3.51)
Day 2	-14.59 (-17.18 to -12.00)	-13.58 (-15.99 to -11.16)
Day 3	-22.56 (-25.19 to -19.93)	-21.26 (-23.73 to -18.79)
Day 4	-25.97 (-28.79 to -23.16)	-26.58 (-29.16 to -24.00)
Day 5	-28.05 (-31.13 to -24.98)	-30.46 (-33.19 to -27.74)
Day 6	-31.76 (-35.15 to -28.37)	-35.40 (-38.28 to -32.52)
Day 7	-32.41 (-36.72 to -28.11)	-37.07 (-41.21 to -32.93)
EOT	-30.03 (-32.40 to -27.66)	-30.14 (-32.34 to -27.95)

Population analysed: mITT population. Only those participants with data available at the specified timepoint were analyzed. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information).

Primary outcome: Adjusted Mean Change From Baseline in WURSS-21 Total QoL Domain Score

Time frame: Baseline and up to Day 7 or EOT. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Robitussin Cough Syrup (Daytime) n = 111	Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) n = 111
Day 1	-3.06 (-5.71 to -0.40)	-3.28 (-5.73 to -0.83)
Day 2	-11.87 (-14.59 to -9.16)	-9.44 (-11.94 to -6.93)
Day 3	-18.40 (-21.16 to -15.63)	-15.49 (-18.07 to -12.91)
Day 4	-21.56 (-24.52 to -18.60)	-20.61 (-23.34 to -17.87)
Day 5	-23.05 (-26.29 to -19.81)	-24.54 (-27.46 to -21.62)
Day 6	-26.40 (-29.98 to -22.83)	-28.63 (-31.76 to -25.50)
Day 7	-28.99 (-33.54 to -24.44)	-27.55 (-32.31 to -22.80)
EOT	-25.57 (-28.08 to -23.05)	-23.54 (-25.86 to -21.23)

Primary outcome: Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Cough

Time frame: Baseline and up to Day 7 or EOT. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Robitussin Cough Syrup (Daytime) n = 111	Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime) n = 111
Day 1	-0.87 (-1.20 to -0.54)	-0.96 (-1.25 to -0.68)
Day 2	-1.91 (-2.26 to -1.57)	-1.77 (-2.06 to -1.48)
Day 3	-2.91 (-3.26 to -2.57)	-2.78 (-3.08 to -2.48)
Day 4	-3.34 (-3.71 to -2.96)	-3.46 (-3.78 to -3.14)
Day 5	-3.66 (-4.07 to -3.25)	-3.78 (-4.12 to -3.43)
Day 6	-4.01 (-4.47 to -3.55)	-4.44 (-4.80 to -4.07)
Day 7	-4.29 (-4.88 to -3.70)	-4.54 (-5.10 to -3.97)
EOT	-3.96 (-4.26 to -3.66)	-3.92 (-4.19 to -3.65)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Immediately after a participant was randomized within the trial and until 2 days following the last administration of study product (approximately up to 10 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Robitussin Cough Syrup (Daytime)	0 of 115 (0%)	2 of 115 (1.7%)	0 of 115
Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime)	0 of 112 (0%)	0 of 112 (0%)	0 of 112

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score (time frame: Baseline and up to Day 7 or End of Treatment (EOT)). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06716645.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.