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

Phase 1

Completed

• Conditions: Mucociliary Clearance
• Interventions: Drug: Placebo; Drug: Mucinex 1200mg

• Registration Number: NCT00902707
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-06-08
• Last Update Posted: 2012-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy
• Non smoker
• BMI 19-29
• Normal lung function

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Exclusion Criteria

• Pregnant
• Smokers
• Any illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Pill
Mucinex 1200mg	Mucinex 1200mg	Pill

Primary Outcome Measures

Name	Time	Method
Difference between drug and placebo in the percentage of particles cleared from the lung.	Measurements at 60, 90 and 180 min
Difference between drug and placebo as an estimate of small airway clearance.	Measurements at 60, 90 and 180 min
Difference between drug and placebo between study days.	Measurements at 60, 90 and 180 min

Secondary Outcome Measures

Name	Time	Method
Blood will be drawn to determination of guaifenesin in the serum.	at baseline and every 30 min x8

Trial Locations

Locations (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology; 🇺🇸 Chapel Hill, North Carolina, United States