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

June 8, 2012 updated by: William Bennett, PhD, University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

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

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC 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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Smokers
  • Any 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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mucinex 1200mg
Pill
Drug: Mucinex 1200mg
Compared to Placebo
Placebo Comparator: Placebo
Pill
Drug: Placebo
Compare to active Mucinex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood will be drawn to determination of guaifenesin in the serum.
Time Frame: at baseline and every 30 min x8
at baseline and every 30 min x8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Reckitt Benckiser Inc.

Investigators

  • Principal Investigator: William Bennett, PhD, University of North Carolina

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

May 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (Estimate)

May 15, 2009

Study Record Updates

Last Update Posted (Estimate)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 8, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-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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