Common ColdPhase 4NCT05556148

Otrivine: Quality of Life (QoL) Impact in a Real-World Setting

A Phase 4 study testing Otrivine Congestion Relief in people with Common Cold, run by HALEON at 1 site in United Kingdom.

Completed

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

Official record

Search all trials

Trial summary

This study is designed to generate real world data from participants with nasal congestion acquired from common cold following treatment with a marketed nasal spray. The main purpose of this study is to evaluate the effectiveness of a nasal spray on quality of life (QoL) factors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Common Cold
What is being tested?: Otrivine Congestion Relief
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 1 siteUnited Kingdom
Study dates: 7 Nov 2022to 20 Dec 2022
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's provision of a signed and dated electronic informed consent (eIC) form indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
Participant reporting a nasal congestion, and at least another common cold symptom among runny nose, sore throat, cough.
Participant reporting a minimum score of 5 (moderate) for plugged nose 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 questionnaire at screening.
Participant reporting initiation of cold symptoms within no longer than 24 hours of prior to initiation of screening.
Participants confirm common cold symptoms within 24 hours of study product receipt of minimum score of 5 (moderate) for plugged nose 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 questionnaire.
Male and female Participants.

Show all 11Show fewer

Participant that owns a smart device and willing to download the study app.
Participant who is willing and able to complete all activities as shown in the Schedule of Activities independently on own smart devices.
Participant is in good general and mental health.
Participant who has a self-reported medical diagnosis of cardiovascular disease (including those with long QT syndrome), hyperthyroidism or diabetes mellitus, may be included if deemed acceptable by a medically qualified investigator.
Participant who is showing a strong reaction to adrenergic substances, as manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmias, or elevated blood pressure, may be included if deemed acceptable by a medically qualified investigator.

Who cannot join

Participants under 18 years of age.
Participants who are allergic to xylometazoline hydrochloride or any of the other ingredients in the spray (see product label).
Participants who have had recent neurosurgery.
Participants who self-report narrow angle glaucoma, chronic nasal inflammation with very dry nasal passages (rhinitis sicca or atrophic rhinitis), or enlarged prostate gland.
Participants who self-report a rare tumor of the adrenal gland that produces high amounts of adrenaline and noradrenaline (phaeochromocytoma).
Participants who are taking monoamine oxidase inhibitors (MAOIs) or have stopped taking them in the last 14 days.

Show all 10Show fewer

Participants who are pregnant, lactating, or plan to be pregnant or lactating during the course of the study.
Participant who is currently using or has used a nasal decongestant (for example, adrenergic, steroids) within the last 7 days (or for more than 7 days) prior to initiating study treatment.
Participants who have tested positive for COVID-19 within one month prior to enrollment into the study.
Participants who have taken a vaccine one week prior to enrollment into the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

The VCTC
Swadlincote, Derbyshire, DE11 7AQ

Other trials in United Kingdom

About this study

Official title: A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Otrivine (Xylometazoline Hydrochloride)

Read the detailed description

This is a longitudinal, open-label study evaluating the effect on QoL factors in participants with the common cold using Otrivine nasal spray (xylometazoline hydrochloride 0.1 percent [%]), in a real-world setting. A sufficient number of adults aged 18 years and over with symptoms of common cold will be screened for eligibility. The study expects to enroll approximately 125 participants to ensure that 100 participants complete the study. All study data will be collected remotely through a study app using the participant's own mobile device.

Conditions: Common Cold
Being tested: Otrivine Congestion Relief
Medical subject headings: Common Cold

What participants receive

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

Otrivine Congestion ReliefDrug
0.1% Nasal Spray (Xylometazoline Hydrochloride)

Study groups in NCT05556148
Study group	Role	What they receive
Otrivine Congestion Relief	Experimental	Participants will be instructed to use the product per label and leaflet instructions: 1 spray in each nostril up to 3 times per day until resolution of symptoms or up to a maximum of 7 days, whichever occurs first. Receives: Drug: Otrivine Congestion Relief

What is being measured

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

Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score
The WURSS is 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 is the short version of this validated survey. Participants rated their cold symptoms and QoL related questions using WURSS-21. It consisted of 10 symptoms questions and 9 QoL questions, the responses of which 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. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptoms and quality of life.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in WURSS-21 Total Symptom Domains Score
The WURSS is 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 is the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severely. Thus, the minimum and maximum possible total score were 0 and 70 respectively, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement of symptoms.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in WURSS-21 Total QoL Domains Score
The WURSS is 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 is the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions, the responses of which 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 a negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement of quality of life.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on each individual symptom. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptoms.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Measured: Baseline (Day 0) up to Day 7
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Measured: Baseline (Day 0) up to Day 7

Secondary outcomes (8)

Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring
Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.
Measured: Days 1, 2, 3, 4, 5, 6, and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness
Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.
Measured: Days 1, 2, 3, 4, 5, 6, and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound
Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.
Measured: Days 1, 2, 3, 4, 5, 6, and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Smell
Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.
Measured: Days 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Taste
Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.
Measured: Days 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People
Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.
Measured: Day 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Energy
Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.
Measured: Days 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation
Health related QoL factors were assessed using questions related to snoring, alertness, self-consciousness about how participants sound, smell, taste, self-consciousness around people, 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. The minimum and maximum score for each question was 0 and 7 respectively, where lower score indicated improvement.
Measured: Days 1, 2, 3, 4, 5, 6 and 7

Timeline

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

7 Nov 202220 Dec 2022

First posted27 Sep 2022
Study start7 Nov 2022
Primary completion20 Dec 2022
Study completion20 Dec 2022

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.
Publications (1)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05556148
Sponsor's protocol ID: 218317
Status last verified: May 2024
First submitted: 22 Sep 2022
Last updated: 17 May 2024
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

Publications

Hagen M, Clark K, Kalita P, Serra G, Sanchez E, Varbiro G, Albasser MM. A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241228927. doi: 10.1177/17534666241228927.
PubMed 38372128

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.

Questions to ask the study team

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?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Probiotic Trial for URTI Prevention in Healthy Adults
Upper Respiratory Tract Infections
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
Recruiting
Effect of Immune X on Common Cold Incidence in Healthy Adults
Common Cold, Upper Respiratory Tract Infection (URTI)
Recruiting
Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
Respiratory Infections

All Common Cold trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2024. 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 Otrivine (Xylometazoline Hydrochloride)
ClinicalTrials.gov ID: NCT05556148
Acronym / sponsor ID: 218317
Conditions: Common Cold
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: HALEONIndustry (pharma, biotech, devices)
Study start: 7 Nov 2022 (actual)
Primary completion: 20 Dec 2022 (actual)
Study completion: 20 Dec 2022 (actual)
First posted: 27 Sep 2022 (actual)
Results: Posted 17 May 2024

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Otrivine Congestion Relief	Experimental	Drug: Otrivine Congestion ReliefParticipants will be instructed to use the product per label and leaflet instructions: 1 spray in each nostril up to 3 times per day until resolution of symptoms or up to a maximum of 7 days, 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 (11 listed)

Participant's provision of a signed and dated electronic informed consent (eIC) form indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
Participant reporting a nasal congestion, and at least another common cold symptom among runny nose, sore throat, cough.
Participant reporting a minimum score of 5 (moderate) for plugged nose 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 questionnaire at screening.
Participant reporting initiation of cold symptoms within no longer than 24 hours of prior to initiation of screening.
Participants confirm common cold symptoms within 24 hours of study product receipt of minimum score of 5 (moderate) for plugged nose 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 questionnaire.

Key exclusion criteria (10 listed)

Participants under 18 years of age.
Participants who are allergic to xylometazoline hydrochloride or any of the other ingredients in the spray (see product label).
Participants who have had recent neurosurgery.
Participants who self-report narrow angle glaucoma, chronic nasal inflammation with very dry nasal passages (rhinitis sicca or atrophic rhinitis), or enlarged prostate gland.
Participants who self-report a rare tumor of the adrenal gland that produces high amounts of adrenaline and noradrenaline (phaeochromocytoma).

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
Otrivine Congestion Relief0.1% Nasal Spray (Xylometazoline Hydrochloride)	Drug	Otrivine Congestion Relief

Primary outcome

Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is the short version of this validated survey. Participants rated their cold symptoms and QoL related questions using WURSS-21. It consisted of 10 symptoms questions and 9 QoL questions, the responses of which 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. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptoms and quality of life.
Change From Baseline in WURSS-21 Total Symptom Domains Score
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severely. Thus, the minimum and maximum possible total score were 0 and 70 respectively, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement of symptoms.
Change From Baseline in WURSS-21 Total QoL Domains Score
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions, the responses of which 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 a negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement of quality of life.
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Plugged Nose
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sneezing
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Sore Throat
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on each individual symptom. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptoms.
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Scratchy Throat
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Cough
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Hoarseness
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Head Congestion
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Chest Congestion
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.
Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Feeling Tired
Time frame: Baseline (Day 0) up to Day 7
The WURSS is 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 is 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, the responses of which were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severely. Thus, the minimum and maximum score for each symptom domain question were 0 and 7, where higher scores indicated a negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value. A negative change from Baseline indicated improvement in symptom.

8 secondary outcomes

Post Otrivine Use Score for Additional Health Related QoL Factors: Snoring
Time frame: Days 1, 2, 3, 4, 5, 6, and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Alertness
Time frame: Days 1, 2, 3, 4, 5, 6, and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious About Sound
Time frame: Days 1, 2, 3, 4, 5, 6, and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Smell
Time frame: Days 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Taste
Time frame: Days 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Self-conscious Around People
Time frame: Day 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Energy
Time frame: Days 1, 2, 3, 4, 5, 6 and 7
Post Otrivine Use Score for Additional Health Related QoL Factors: Motivation
Time frame: Days 1, 2, 3, 4, 5, 6 and 7

Results and safety

Results posted to the registry on 17 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)	136	100

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

Time frame: Baseline (Day 0) up to Day 7. Mean (Standard Deviation). Unit: score on a scale

Measure	Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) n = 102
Baseline	75.8 (20.23)
Change from Baseline at Day 1	-1.5 (14.57)
Change from Baseline at Day 2	-15.4 (22)
Change from Baseline at Day 3	-27.3 (27.94)
Change from Baseline at Day 4	-35.0 (30.21)
Change from Baseline at Day 5	-38.5 (28.31)
Change from Baseline at Day 6	-39.7 (27.12)
Change from Baseline at Day 7	-52.6 (29.7)

Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): -1.54 (95% CI -4.44 to 1.37), p = 0.2968, Student's paired t-test
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): -15.36 (95% CI -19.77 to -10.95), p <.0001, Student's paired t-test
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): -27.27 (95% CI -33.06 to -21.49), p <.0001, Student's paired t-test

Population analysed: The 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 indicated timepoints were analyzed.

Primary outcome: Change From Baseline in WURSS-21 Total Symptom Domains Score

Time frame: Baseline (Day 0) up to Day 7. Mean (Standard Deviation). Unit: score on a scale

Measure	Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) n = 102
Baseline	38.3 (11.35)
Change from Baseline at Day 1	0.3 (7.85)
Change from Baseline at Day 2	-6.2 (11.44)
Change from Baseline at Day 3	-12.1 (13.96)
Change from Baseline at Day 4	-16.0 (14.88)
Change from Baseline at Day 5	-19.4 (14.77)
Change from Baseline at Day 6	-19.4 (14.4)
Change from Baseline at Day 7	-25.4 (17.32)

Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): 0.29 (95% CI -1.27 to 1.86), p = 0.7112, Student's paired t-test
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): -6.21 (95% CI -8.51 to -3.92), p <.0001, Student's paired t-test
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): -12.11 (95% CI -15.00 to -9.22), p <.0001, Student's paired t-test

Population analysed: mITT population. Only those participants with data available at the indicated timepoints were analyzed.

Primary outcome: Change From Baseline in WURSS-21 Total QoL Domains Score

Time frame: Baseline (Day 0) up to Day 7. Mean (Standard Deviation). Unit: score on a scale

Measure	Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) n = 102
Baseline	37.5 (11.61)
Change From Baseline at Day 1	-1.8 (9.09)
Change From Baseline at Day 2	-9.1 (12.95)
Change From Baseline at Day 3	-15.2 (15.84)
Change From Baseline at Day 4	-19.1 (17.17)
Change From Baseline at Day 5	-19.1 (16.5)
Change From Baseline at Day 6	-20.3 (16.62)
Change From Baseline at Day 7	-27.2 (14.14)

Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): -1.83 (95% CI -3.64 to -0.02), p = 0.0481, Student's paired t-test
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): -9.14 (95% CI -11.74 to -6.55), p <.0001, Student's paired t-test
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): -15.16 (95% CI -18.44 to -11.88), p <.0001, Student's paired t-test

Population analysed: mITT population. Only those participants with data available at the indicated timepoints were analyzed.

Primary outcome: Change From Baseline in Each of the WURSS-21 Symptom Domains Score: Runny Nose

Time frame: Baseline (Day 0) up to Day 7. Mean (Standard Deviation). Unit: score on a scale

Measure	Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride) n = 102
Baseline	4.0 (1.86)
Change from Baseline at Day 1	0.0 (1.53)
Change from Baseline at Day 2	-0.6 (1.68)
Change from Baseline at Day 3	-1.1 (1.93)
Change from Baseline at Day 4	-1.7 (2.20)
Change from Baseline at Day 5	-1.7 (2.24)
Change from Baseline at Day 6	-1.9 (1.90)
Change from Baseline at Day 7	-2.5 (2.21)

Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): 0.00 (95% CI -0.31 to 0.31), p = 1.0000, Student's paired t-test
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): -0.63 (95% CI -0.97 to -0.30), p = 0.0003, Student's paired t-test
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride): Mean Difference (Final Values): -1.10 (95% CI -1.50 to -0.70), p <.0001, Student's paired t-test

Population analysed: mITT population. Only those participants with data available at the indicated timepoints were analyzed.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study product administration up to Day 7. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Otrivine Congestion Relief 0.1% Nasal Spray (Xylometazoline Hydrochloride)	0 of 102 (0%)	6 of 102 (5.9%)	0 of 136

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38372128Hagen M, Clark K, Kalita P, Serra G, Sanchez E, Varbiro G, Albasser MM. A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241228927. doi: 10.1177/17534666241228927.
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

Related trials for Common Cold

Recruiting
Probiotic Trial for URTI Prevention in Healthy Adults
Upper Respiratory Tract Infections
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
Recruiting
Effect of Immune X on Common Cold Incidence in Healthy Adults
Common Cold, Upper Respiratory Tract Infection (URTI)
Recruiting
Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
Respiratory Infections

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?

A Phase 4 study testing Otrivine Congestion Relief in people with Common Cold, run by HALEON at 1 site in United Kingdom.

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 11 inclusion and 10 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 17 May 2024. 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 Kingdom. 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 17 May 2024). 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?

Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score (time frame: Baseline (Day 0) up to Day 7). The study lists 13 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 NCT05556148, which also lists 1 linked publication.

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 17 May 2024.