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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
History of Changes
  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:

MedlinePlus related topics: Cough
U.S. FDA Resources

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
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 May 19, 2013