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NCT01114581 Clinical Trial

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

Acute Respiratory Infection Clinical Trial

— MCC/CC  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01114581
Other study ID # 2010-MUC-01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2010
Est. completion date April 2011

Study information
Verified date August 2018
Source Reckitt Benckiser LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mucinex
Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study
• Placebo
Placebo given as 2 tablets

Locations
Country Name City State
United States Center for Environmental Medicine, Asthma, and Lung Biology Chapel Hill North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Reckitt Benckiser LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs Percentage of inhaled radioactive tracer (Ave180Clear) 3 hours following inhalation of radioactive tracer particles
Secondary Guaifenesin AUC(0-3) 3 hours following dose administration
Secondary Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo. Within 10 days of developing symptoms associated with a respiratory tract infection
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