- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01114581
Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection (MCC/CC)
August 20, 2018 updated by: Reckitt Benckiser LLC
The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Center for Environmental Medicine, Asthma, and Lung Biology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Symptoms of cough, thickened mucus and chest congestion
- Able to produce sputum
- Non Smoker
Exclusion Criteria:
- Pregnant
- Smokers
- Fever above 101°F
- Any chronic illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Guaifenesin
Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
|
Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study
|
Placebo Comparator: Placebo
Given as 2 tablets
|
Placebo given as 2 tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs
Time Frame: 3 hours following inhalation of radioactive tracer particles
|
Percentage of inhaled radioactive tracer (Ave180Clear)
|
3 hours following inhalation of radioactive tracer particles
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Guaifenesin AUC(0-3)
Time Frame: 3 hours following dose administration
|
3 hours following dose administration
|
Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.
Time Frame: Within 10 days of developing symptoms associated with a respiratory tract infection
|
Within 10 days of developing symptoms associated with a respiratory tract infection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William Bennett, PhD, University of North Carolina
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
April 28, 2010
First Submitted That Met QC Criteria
April 29, 2010
First Posted (Estimate)
May 3, 2010
Study Record Updates
Last Update Posted (Actual)
September 19, 2018
Last Update Submitted That Met QC Criteria
August 20, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Infections
- Respiratory Tract Infections
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Respiratory System Agents
- Appetite Depressants
- Anti-Obesity Agents
- Sympathomimetics
- Expectorants
- Vasoconstrictor Agents
- Nasal Decongestants
- Phenylpropanolamine
- Guaifenesin
- Chlorpheniramine, phenylpropanolamine drug combination
Other Study ID Numbers
- 2010-MUC-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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