Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection (MCC/CC)

August 20, 2018 updated by: Reckitt Benckiser LLC
The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

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
        • 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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptoms of cough, thickened mucus and chest congestion
  • Able to produce sputum
  • Non Smoker

Exclusion Criteria:

  • Pregnant
  • Smokers
  • Fever above 101°F
  • Any chronic 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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Guaifenesin
Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
Drug: Mucinex
Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study
Placebo Comparator: Placebo
Given as 2 tablets
Drug: Placebo
Placebo given as 2 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs
Time Frame: 3 hours following inhalation of radioactive tracer particles
Percentage of inhaled radioactive tracer (Ave180Clear)
3 hours following inhalation of radioactive tracer particles

Secondary Outcome Measures

Outcome Measure
Time Frame
Guaifenesin AUC(0-3)
Time Frame: 3 hours following dose administration
3 hours following dose administration
Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.
Time Frame: Within 10 days of developing symptoms associated with a respiratory tract infection
Within 10 days of developing symptoms associated with a respiratory tract infection

Collaborators and Investigators

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

Sponsor

Reckitt Benckiser LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

April 29, 2010

First Posted (Estimate)

May 3, 2010

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-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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