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

Primary Purpose

Acute Respiratory Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mucinex
Placebo
Sponsored by
Reckitt Benckiser LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Infection focused on measuring Acute Respiratory Infection, Mucociliary, Cough Clearance, Guaifenesin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Environmental Medicine, Asthma, and Lung Biology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Guaifenesin

Placebo

Arm Description

Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets

Given as 2 tablets

Outcomes

Primary Outcome Measures

Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs
Percentage of inhaled radioactive tracer (Ave180Clear)

Secondary Outcome Measures

Guaifenesin AUC(0-3)
Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.

Full Information

First Posted
April 28, 2010
Last Updated
August 20, 2018
Sponsor
Reckitt Benckiser LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01114581
Brief Title
Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection
Acronym
MCC/CC
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reckitt Benckiser LLC

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infection
Keywords
Acute Respiratory Infection, Mucociliary, Cough Clearance, Guaifenesin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guaifenesin
Arm Type
Active Comparator
Arm Description
Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Given as 2 tablets
Intervention Type
Drug
Intervention Name(s)
Mucinex
Intervention Description
Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given as 2 tablets
Primary Outcome Measure Information:
Title
Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs
Description
Percentage of inhaled radioactive tracer (Ave180Clear)
Time Frame
3 hours following inhalation of radioactive tracer particles
Secondary Outcome Measure Information:
Title
Guaifenesin AUC(0-3)
Time Frame
3 hours following dose administration
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Bennett, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Environmental Medicine, Asthma, and Lung Biology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26462765
Citation
Bennett WD, Kala A, Duckworth H, Zeman KL, Wu J, Henderson A, Yopp M, Rubin BK. Effect of a single 1200 Mg dose of Mucinex(R) on mucociliary and cough clearance during an acute respiratory tract infection. Respir Med. 2015 Nov;109(11):1476-83. doi: 10.1016/j.rmed.2015.09.017. Epub 2015 Oct 9.
Results Reference
derived

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Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection

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