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

NCT ID: NCT00902707

Last Updated: 2012-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Mucociliary Clearance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mucinex 1200mg

Pill

Group Type EXPERIMENTAL

Mucinex 1200mg

Intervention Type DRUG

Compared to Placebo

Placebo

Pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Compare to active Mucinex

Interventions

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Mucinex 1200mg

Compared to Placebo

Intervention Type DRUG

Placebo

Compare to active Mucinex

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant
* Smokers
* Any illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Reckitt Benckiser Inc.

INDUSTRY

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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William Bennett, PhD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Bennett, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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2009-MUC-01

Identifier Type: -

Identifier Source: org_study_id

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