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
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Infection
Drug: Mucinex
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser LLC:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 38
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114581

Locations
United States, North Carolina
Center for Environmental Medicine, Asthma, and Lung Biology
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Reckitt Benckiser LLC
Investigators
Principal Investigator: William Bennett, PhD University of North Carolina
  More Information

No publications provided

Responsible Party: William Bennett, PhD, UNC at Chapel Hill
ClinicalTrials.gov Identifier: NCT01114581     History of Changes
Other Study ID Numbers: 2010-MUC-01
Study First Received: April 28, 2010
Results First Received: March 15, 2012
Last Updated: September 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Reckitt Benckiser LLC:
Acute Respiratory Infection
Mucociliary
Cough Clearance
Guaifenesin

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 28, 2014