Common ColdPhase 2NCT03005067

To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold

A Phase 2 study testing Carbomer 980 (1146A) in people with Common Cold, run by GlaxoSmithKline at 24 sites 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

This study will be conducted in adult participants with symptoms of common cold assessing if 1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo. The study will also evaluate the safety of 1146A compared to placebo. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Common Cold
What is being tested?: Carbomer 980 (1146A)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 171 participants
Where: 24 sitesUnited States
Study dates: 29 Dec 2016to 7 Jun 2017
Phase: Phase 2
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Aged between 18 to 75 years inclusive.
Male or female.
Good general and mental health with, in the opinion of the Investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical and Investigator-led nasal examination.
Females of childbearing potential who are, in the opinion of the Investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap (diaphragm or cervical vault caps) plus spermicidal agent (foam, gel, film, cream, suppository)) OR male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant.
Investigator confirmed diagnosis of symptomatic common cold with an onset of less than 48 hours prior to randomization. Symptomatic common cold is defined as TSS > 9 AND a score >1 for at least one of the following symptoms: sore throat, runny nose, or blocked nose.

Who cannot join

Women who have a positive urine pregnancy test.
Women who are breast-feeding.
During the entire study (Screening - last participant visit):
A. Participant who have used medications or therapies that could interfere with study evaluations and have not had the proper washout period from these medications or therapies or are anticipated to require any concomitant intranasal medication during that period or at any time throughout the study.
B. Nasal disease(s) likely to affect deposition of intranasal medication, such as chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities.
C. Nasal surgery or sinus surgery within the previous year.

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D. Any condition that prohibits the participant from actuating nasal spray devices (severe rheumatoid arthritis; deformed hands and fingers; missing fingers).
E. Clinically relevant abnormal physical findings which, in the opinion of the Investigator or sponsor's medical monitor, would interfere with the objectives of the study or that may preclude compliance with the study procedures.
F. Uncontrolled cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrine, metabolic, autoimmune, neurological, psychiatric or other diseases at screening that would interfere with the study in the opinion of the Investigator.
G. Participants with seasonal allergic rhinitis if randomization occurs during their expected allergy season or perennial allergic rhinitis.
H. Severe COPD, persistent asthma, or recent COPD/asthma exacerbation.
I. An inability to comprehend and satisfactorily use the measurement instruments as determined by the study sites staff on screening.
J. Participants with a fever > 38°C (100.4°F).
K. Frequent uses of analgesics (i.e. have taken an analgesic for pain in headache and pain in muscle/joints for at least 1 dose per week on average over the past 6 months).
Known or suspected intolerance or hypersensitivity to any of the study medications, excipients or investigational device material or to medications of similar chemical classes, any history of drug hypersensitivity or other significant allergic diathesis that could affect study participation and known or suspected contraindications, including history of allergy or photosensitivity to study medication/s.
Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit or 5 half-lives of enrollment, whichever is longer and previous participation in this study (i.e. participants cannot be re-screened or randomized).
Recent history (within the last 5 years) of alcohol or other substance abuse and positive urine drug screen.
An employee of the sponsor or the study sites or members of their immediate family and persons directly or indirectly involved in the execution of this protocol, including employees of the contract research organization (CRO) and persons related to them.
On nasal examination by Investigator, the presence of nasal disease likely to affect deposition of intranasal treatment or any superficial or moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation at the screening visit. Participants with difficulty in using the nasal spray applicator, "vulnerable" individual (as defined by the IRB e.g. incarcerated person) and any condition not identified in the protocol that in the opinion of the Investigator would confound the evaluation and interpretation of the study data or may put the participant at risk.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

GSK Investigational Site
Akron, Ohio, 44311
GSK Investigational Site
Anderson, South Carolina, 29621
GSK Investigational Site
Bellevue, Washington, 98004
GSK Investigational Site
Birmingham, Alabama, 35211
GSK Investigational Site
Centennial, Colorado, 80112
GSK Investigational Site
Chandler, Arizona, 85224
GSK Investigational Site
Chicago, Illinois, 60602
GSK Investigational Site
Cincinnati, Ohio, 45249
GSK Investigational Site
Council Bluffs, Iowa, 51503
GSK Investigational Site
Dallas, Texas, 75234
GSK Investigational Site
Edina, Minnesota, 55435
GSK Investigational Site
Elkhorn, Nebraska, 68022
GSK Investigational Site
Fremont, Nebraska, 68025
GSK Investigational Site
Hatboro, Pennsylvania, 19040
GSK Investigational Site
Littleton, Colorado, 80128
GSK Investigational Site
Mesa, Arizona, 85206
GSK Investigational Site
Murray, Utah, 84123
GSK Investigational Site
Omaha, Nebraska, 68144
GSK Investigational Site
Pinellas Park, Florida, 33781
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Vineland, New Jersey
GSK Investigational Site
Vista, California, 92083

Other trials in United States

About this study

Official title: A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Subjects With Symptoms of Common Cold

Read the detailed description

This will be a multi-center, randomized, parallel-group, double blind, 2-arm, placebo controlled study to evaluate the efficacy and safety of 1146A in adult participants with symptomatic common cold in an outpatient setting.

Conditions: Common Cold
Being tested: Carbomer 980 (1146A), Placebo
Medical subject headings: Common Cold

What participants receive

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

Carbomer 980 (1146A)Drug
Test product containing carbomer 980 gel
PlaceboOther
Reference product containing vehicle without carbomer 980 gel

Study groups in NCT03005067
Study group	Role	What they receive
Carbomer 980 (1146A)	Experimental	Participants will be administered test product (nasal spray) containing carbomer 980 gel. Three actuations per nostril per dose will be applied, each actuation will be 140µL (microliters) i.e. equivalent to 140mg. Receives: Drug: Carbomer 980 (1146A)
Placebo	Placebo comparator	Participants will be administered reference product (nasal spray) containing vehicle without carbomer 980. Three actuations of placebo nasal spray per nostril per dose; each actuation will be 140µL. Receives: Other: Placebo

What is being measured

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

Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)
The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.
Measured: Up to Day 4 (Day 1 to 4)

Secondary outcomes (3)

Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)
The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 7 was calculated as the mean of the 7 daily NSS across study days 1 to 7. A lower score reflects better nasal symptoms.
Measured: Up to Day 7 (Day 1 to 7)
Average Total Symptom Score Over Days 1-4 (ATSS1-4)
The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 4 were derived as the mean of all TSS across study Days 1 to 4. A lower score reflects better nasal symptoms.
Measured: Up to Day 4 (Day 1 to 4)
Average Total Symptom Score Over Days 1-7 (ATSS1-7)
The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 7 were derived as the mean of all TSS across study Days 1 to 7. A lower score reflects better nasal symptoms.
Measured: Up to Day 7 (Day 1 to 7)

Timeline

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

29 Dec 20167 Jun 2017

First posted29 Dec 2016 (estimated)
Study start29 Dec 2016
Primary completion7 Jun 2017
Study completion7 Jun 2017

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 GlaxoSmithKlineThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 171 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03005067
Sponsor's protocol ID: 205684
Status last verified: Apr 2018
First submitted: 7 Dec 2016
Last updated: 19 Jun 2018
Results posted: Yes, on ClinicalTrials.gov

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

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Subjects With Symptoms of Common Cold
ClinicalTrials.gov ID: NCT03005067
Acronym / sponsor ID: 205684
Conditions: Common Cold
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 171 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 29 Dec 2016 (actual)
Primary completion: 7 Jun 2017 (actual)
Study completion: 7 Jun 2017 (actual)
First posted: 29 Dec 2016 (estimated)
Results: Posted 19 Jun 2018

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Carbomer 980 (1146A)	Experimental	Drug: Carbomer 980 (1146A)Participants will be administered test product (nasal spray) containing carbomer 980 gel. Three actuations per nostril per dose will be applied, each actuation will be 140µL (microliters) i.e. equivalent to 140mg.
Placebo	Placebo comparator	Other: PlaceboParticipants will be administered reference product (nasal spray) containing vehicle without carbomer 980. Three actuations of placebo nasal spray per nostril per dose; each actuation will be 140µL.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Aged between 18 to 75 years inclusive.
Male or female.
Good general and mental health with, in the opinion of the Investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical and Investigator-led nasal examination.
Females of childbearing potential who are, in the opinion of the Investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap (diaphragm or cervical vault caps) plus spermicidal agent (foam, gel, film, cream, suppository)) OR male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant.

Key exclusion criteria (19 listed)

Women who have a positive urine pregnancy test.
Women who are breast-feeding.
During the entire study (Screening - last participant visit):
A. Participant who have used medications or therapies that could interfere with study evaluations and have not had the proper washout period from these medications or therapies or are anticipated to require any concomitant intranasal medication during that period or at any time throughout the study.
B. Nasal disease(s) likely to affect deposition of intranasal medication, such as chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities.

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
Carbomer 980 (1146A)Test product containing carbomer 980 gel	Drug	Carbomer 980 (1146A)
PlaceboReference product containing vehicle without carbomer 980 gel	Other	Placebo

Primary outcome

Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)
Time frame: Up to Day 4 (Day 1 to 4)
The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.

3 secondary outcomes

Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)
Time frame: Up to Day 7 (Day 1 to 7)
Average Total Symptom Score Over Days 1-4 (ATSS1-4)
Time frame: Up to Day 4 (Day 1 to 4)
Average Total Symptom Score Over Days 1-7 (ATSS1-7)
Time frame: Up to Day 7 (Day 1 to 7)

Results and safety

Results posted to the registry on 19 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Product	90	80
Placebo Nasal Spray	81	74

Primary outcome: Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)

Time frame: Up to Day 4 (Day 1 to 4). Mean (Standard Deviation). Unit: Score on a scale

Measure	Test Product n = 86	Placebo Nasal Spray n = 79
Value	3.428 (1.4784)	3.336 (1.6917)

Test Product vs Placebo Nasal Spray: Mean Difference (Net): 0.137 (95% CI -0.279 to 0.553), p = 0.516, ANCOVA

Population analysed: Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 8 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product	1 of 87 (1.1%)	32 of 87 (36.8%)	0 of 87
Placebo Nasal Spray	0 of 81 (0%)	34 of 81 (42%)	0 of 81

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Common Cold

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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
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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.

GSK Clinical Trials study director

GlaxoSmithKline

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carbomer 980 (1146A) in people with Common Cold, run by GlaxoSmithKline at 24 sites in United States.

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 6 inclusion and 19 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Jun 2018). 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?

Average Nasal Symptom Score Over Days 1-4 (ANSS1-4) (time frame: Up to Day 4 (Day 1 to 4)). 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 NCT03005067.

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 19 Jun 2018.