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Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung

This study has been completed.
Sponsor:
Collaborator:
Reckitt Benckiser LLC
Information provided by (Responsible Party):
William Bennett, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00902707
First received: May 13, 2009
Last updated: June 8, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.


Condition Intervention Phase
Mucociliary Clearance
 Drug: Mucinex 1200mg
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Open-Label, 2-way Crossover Placebo-Controlled , Radio-Labeled Tracer Study Evaluating the Effect of MUCINEX® 1200 mg on Mucociliary and Cough Clearance From The Human Lung In Healthy, Non-Smoking Adults

Resource links provided by NLM:

MedlinePlus related topics: Cough
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Difference between drug and placebo in the percentage of particles cleared from the lung. [ Time Frame: Measurements at 60, 90 and 180 min ] [ Designated as safety issue: No ]
  • Difference between drug and placebo as an estimate of small airway clearance. [ Time Frame: Measurements at 60, 90 and 180 min ] [ Designated as safety issue: No ]
  • Difference between drug and placebo between study days. [ Time Frame: Measurements at 60, 90 and 180 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood will be drawn to determination of guaifenesin in the serum. [ Time Frame: at baseline and every 30 min x8 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mucinex 1200mg
Pill
 Drug: Mucinex 1200mg
Compared to Placebo
Placebo Comparator: Placebo
Pill
 Drug: Placebo
Compare to active Mucinex

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Non smoker
  • BMI 19-29
  • Normal lung function

Exclusion Criteria:

  • Pregnant
  • Smokers
  • Any illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902707

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

No publications provided

Responsible Party: William Bennett, PhD, Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00902707     History of Changes
Other Study ID Numbers: 2009-MUC-01
Study First Received: May 13, 2009
Last Updated: June 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
healthy nonsmokers

Additional relevant MeSH terms:
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 23, 2013