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

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ClinicalTrials.gov Identifier: NCT01114581
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : October 8, 2012
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC

Tracking Information
First Submitted Date  ICMJE April 28, 2010
First Posted Date  ICMJE May 3, 2010
Results First Submitted Date  ICMJE March 15, 2012
Results First Posted Date  ICMJE October 8, 2012
Last Update Posted Date September 19, 2018
Study Start Date  ICMJE April 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2010)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
  • Guaifenesin AUC(0-3) [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2010)
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Respiratory Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Guaifenesin
    Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
    Intervention: Drug: Mucinex
  • Placebo Comparator: Placebo
    Given as 2 tablets
    Intervention: Drug: Placebo
Publications * 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® 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2010)
38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01114581
Other Study ID Numbers  ICMJE 2010-MUC-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Reckitt Benckiser LLC
Study Sponsor  ICMJE Reckitt Benckiser LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Bennett, PhD University of North Carolina
PRS Account Reckitt Benckiser LLC
Verification Date August 2018

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