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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00902707
Enrollment
12
Registered
2009-05-15
Start date
2009-05-31
Completion date
2012-05-31
Last updated
2012-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucociliary Clearance

Keywords

healthy nonsmokers

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.

Interventions

DRUGPlacebo

Compare to active Mucinex

DRUGMucinex 1200mg

Compared to Placebo

Sponsors

Reckitt Benckiser Inc.
CollaboratorINDUSTRY
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Pregnant * Smokers * Any illness

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Blood will be drawn to determination of guaifenesin in the serum.at baseline and every 30 min x8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026