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

This study has been completed.
Sponsor:
Information provided by:
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01114581
First received: April 28, 2010
Last updated: September 7, 2012
Last verified: September 2012

April 28, 2010
September 7, 2012
April 2010
April 2011   (final data collection date for primary outcome measure)
Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs [ Time Frame: 3 hours following inhalation of radioactive tracer particles ] [ Designated as safety issue: No ]
Percentage of inhaled radioactive tracer (Ave180Clear)
Assess biological effect between Mucinex 1200mg and placebo on mucociliary and cough clearance during an acute RTI by quantifying rate of removal from the lung of inhaled radioactive tracer particles in otherwise healthy, non-smoking adults. [ Time Frame: Within 10 days of developing symptoms associated with a respiratory tract infection ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01114581 on ClinicalTrials.gov Archive Site
  • Guaifenesin AUC(0-3) [ Time Frame: 3 hours following dose administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Blood will be drawn to determine amount of Mucinex in the serum. [ Time Frame: Pre-dose, 15, 30 and 45 minutes post-dose, 1, 1.5, 2, 2.5 and 3 hrs post-dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Acute Respiratory Infection
  • Drug: Mucinex
    Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study
  • Drug: Placebo
    Placebo given as 2 tablets
  • Active Comparator: Guaifenesin
    Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
    Intervention: Drug: Mucinex
  • Placebo Comparator: Placebo
    Given as 2 tablets
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01114581
2010-MUC-01
Not Provided
William Bennett, PhD, UNC at Chapel Hill
Reckitt Benckiser LLC
Not Provided
Principal Investigator: William Bennett, PhD University of North Carolina
Reckitt Benckiser LLC
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP