Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection
MCC/CC
1 other identifier
interventional
38
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 28, 2010
CompletedFirst Posted
Study publicly available on registry
May 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
October 8, 2012
CompletedSeptember 19, 2018
August 1, 2018
1 year
April 28, 2010
March 15, 2012
August 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs
Percentage of inhaled radioactive tracer (Ave180Clear)
3 hours following inhalation of radioactive tracer particles
Secondary Outcomes (2)
Guaifenesin AUC(0-3)
3 hours following dose administration
Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.
Within 10 days of developing symptoms associated with a respiratory tract infection
Study Arms (2)
Guaifenesin
ACTIVE COMPARATORMucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
Placebo
PLACEBO COMPARATORGiven as 2 tablets
Interventions
Eligibility Criteria
You may qualify if:
- Symptoms of cough, thickened mucus and chest congestion
- Able to produce sputum
- Non Smoker
You may not qualify if:
- Pregnant
- Smokers
- Fever above 101°F
- Any chronic illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Environmental Medicine, Asthma, and Lung Biology
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
Bennett WD, Kala A, Duckworth H, Zeman KL, Wu J, Henderson A, Yopp M, Rubin BK. Effect of a single 1200 Mg dose of Mucinex(R) on mucociliary and cough clearance during an acute respiratory tract infection. Respir Med. 2015 Nov;109(11):1476-83. doi: 10.1016/j.rmed.2015.09.017. Epub 2015 Oct 9.
PMID: 26462765DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gail Solomon, Director, Clinical Development
- Organization
- Reckitt Benckiser Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
William Bennett, PhD
University of North Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2010
First Posted
May 3, 2010
Study Start
April 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
September 19, 2018
Results First Posted
October 8, 2012
Record last verified: 2018-08