Common ColdPhase 2NCT01046136

Mucinex Exploratory Cold Study

A Phase 2 study testing guaifenesin (Mucinex) in people with Common Cold, run by Reckitt Benckiser Inc. 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

This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Common Cold
What is being tested?: guaifenesin (Mucinex)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 378 participants
Where: 1 siteUnited States
Study dates: Dec 2009to Mar 2010
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

common cold symptoms
meet symptom severity
females of child-bearing potential must have negative pregnancy test and use effective birth control

Who cannot join

chronic respiratory conditions
significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder
pregnant or lactating
known malignancy
participation in any other clinical trial within 30 days of baseline
related to another enrolled patient or persons involved directly or indirectly with the conduct of this study

Trial locations and contacts

1 site in 1 country.

United States1 site

Pioneer Clinical Research
Bellevue, Nebraska, 68005

Other trials in United States

About this study

Official title: Double Blind, Randomized, Placebo Controlled Study of Mucinex® for the Treatment of Symptoms of an Acute Respiratory Tract Infection When Two 600 mg Tablets Are Given Every 12 Hours for 7 Days

Conditions: Common Cold
Being tested: guaifenesin (Mucinex), placebo
Keywords: common cold
Medical subject headings: Common Cold

What participants receive

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

guaifenesin (Mucinex)Drug
bid 7 days
placeboDrug
bid 7 days

Study groups in NCT01046136
Study group	Role	What they receive
Mucinex	Active comparator	Not described Receives: Drug: guaifenesin (Mucinex)
placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

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

Investigator's End of Study Assessment of Treatment
Yes the investigator would use this treatment for cold symptoms in the future.
Measured: 7 days
Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.
Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.
Measured: Baseline and Day 4

Secondary outcomes (1)

Number of Patients With Adverse Events
Total number of patients with adverse events that were possibly or probably related.
Measured: 7 days

Timeline

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

Dec 2009Mar 2010

First posted11 Jan 2010 (estimated)
Study startDec 2009
Primary completionMar 2010

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 (2)Papers the sponsor has linked to this study.
Other trials for Common ColdStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 378 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01046136
Sponsor's protocol ID: 2009-MUC-03
Status last verified: Dec 2020
First submitted: 7 Jan 2010
Last updated: 30 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hoffer-Schaefer A, Rozycki HJ, Yopp MA, Rubin BK. Guaifenesin has no effect on sputum volume or sputum properties in adolescents and adults with acute respiratory tract infections. Respir Care. 2014 May;59(5):631-6. doi: 10.4187/respcare.02640. Epub 2013 Sep 3.
PubMed 24003241
Albrecht H, Vernon M, Solomon G. Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms. Respir Res. 2012 Dec 27;13(1):118. doi: 10.1186/1465-9921-13-118.
PubMed 23270519

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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All Common Cold trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double Blind, Randomized, Placebo Controlled Study of Mucinex® for the Treatment of Symptoms of an Acute Respiratory Tract Infection When Two 600 mg Tablets Are Given Every 12 Hours for 7 Days
ClinicalTrials.gov ID: NCT01046136
Acronym / sponsor ID: 2009-MUC-03
Conditions: Common Cold
Keywords: common cold
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 378 participants (actual)
Lead sponsor: Reckitt Benckiser Inc.Industry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Mar 2010 (actual)
First posted: 11 Jan 2010 (estimated)
Results: Posted 24 Aug 2012

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mucinex	Active comparator	Drug: guaifenesin (Mucinex)
placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

common cold symptoms
meet symptom severity
females of child-bearing potential must have negative pregnancy test and use effective birth control

Key exclusion criteria (6 listed)

chronic respiratory conditions
significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder
pregnant or lactating
known malignancy
participation in any other clinical trial within 30 days of baseline

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
guaifenesin (Mucinex)bid 7 days	Drug	Mucinex
placebobid 7 days	Drug	placebo

Primary outcome

Investigator's End of Study Assessment of Treatment
Time frame: 7 days
Yes the investigator would use this treatment for cold symptoms in the future.
Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.
Time frame: Baseline and Day 4
Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.

1 secondary outcome

Number of Patients With Adverse Events
Time frame: 7 days

Results and safety

Results posted to the registry on 24 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mucinex	188	184
Placebo	190	182

Primary outcome: Investigator's End of Study Assessment of Treatment

Time frame: 7 days. Number. Unit: participants

Measure	Mucinex n = 178	Placebo n = 180
Value	163	149

Mucinex vs Placebo: p = 0.0096, Regression, Logistic

Population analysed: MITT defined as all participants receiving at least 1 dose of study medication and had 1 or more efficacy assessment after Baseline. Last observation carried forward method was applied to missing post baseline measurement in the analyses of the MITT population.

Primary outcome: Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.

Time frame: Baseline and Day 4. Mean (Standard Deviation). Unit: units on a scale

Measure	Mucinex n = 183	Placebo n = 186
Value	-1.1 (0.14)	-0.9 (0.14)

Mucinex vs Placebo: p = 0.0293, Wilcoxon (Mann-Whitney)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected through the treatment period. All patients who received at least 1 dose of study medication were included in the safety analysis.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mucinex	1 of 188 (0.5%)	0 of 188 (0%)	Not reported
Placebo	0 of 189 (0%)	0 of 189 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24003241Hoffer-Schaefer A, Rozycki HJ, Yopp MA, Rubin BK. Guaifenesin has no effect on sputum volume or sputum properties in adolescents and adults with acute respiratory tract infections. Respir Care. 2014 May;59(5):631-6. doi: 10.4187/respcare.02640. Epub 2013 Sep 3.
Derived from this study: PubMed 23270519Albrecht H, Vernon M, Solomon G. Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms. Respir Res. 2012 Dec 27;13(1):118. doi: 10.1186/1465-9921-13-118.

Related trials for Common Cold

Recruiting
Effect of Immune X on Common Cold Incidence in Healthy Adults
Common Cold, Upper Respiratory Tract Infection (URTI)
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
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Recruiting
Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
Respiratory Infections
Recruiting
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
Acute Rhinitis, Nasal Obstruction

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 2 study testing guaifenesin (Mucinex) in people with Common Cold, run by Reckitt Benckiser Inc. at 1 site 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 3 inclusion and 6 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 30 Dec 2020. 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. 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 24 Aug 2012). 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?

Investigator's End of Study Assessment of Treatment (time frame: 7 days). The study lists 2 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 NCT01046136, which also lists 2 linked publications.

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 30 Dec 2020.