Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung

Mucociliary Clearance Clinical Trial

Official title:

An Open-Label, 2-way Crossover Placebo-Controlled , Radio-Labeled Tracer Study Evaluating the Effect of MUCINEX® 1200 mg on Mucociliary and Cough Clearance From The Human Lung In Healthy, Non-Smoking Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902707
• Other study ID #: 2009-MUC-01
• Status: Completed
• Phase: Phase 1
• First received: May 13, 2009
• Last updated: June 8, 2012
• Start date: May 2009
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy

• Non smoker

• BMI 19-29

• Normal lung function

Exclusion Criteria:

• Pregnant

• Smokers

• Any illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucociliary Clearance

Intervention

Drug:
• Mucinex 1200mg
Compared to Placebo
• Placebo
Compare to active Mucinex

Locations

Country	Name	City	State
United States	UNC Center for Environmental Medicine, Asthma and Lung Biology	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Reckitt Benckiser LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between drug and placebo in the percentage of particles cleared from the lung.		Measurements at 60, 90 and 180 min	No
Primary	Difference between drug and placebo as an estimate of small airway clearance.		Measurements at 60, 90 and 180 min	No
Primary	Difference between drug and placebo between study days.		Measurements at 60, 90 and 180 min	No
Secondary	Blood will be drawn to determination of guaifenesin in the serum.		at baseline and every 30 min x8	No