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Trial record 8 of 433 for:    guaifenesin | Completed Studies

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902707
First Posted: May 15, 2009
Last Update Posted: June 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Reckitt Benckiser LLC
Information provided by (Responsible Party):
William Bennett, PhD, University of North Carolina, Chapel Hill
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by William Bennett, PhD, 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 ]
  • Difference between drug and placebo as an estimate of small airway clearance. [ Time Frame: Measurements at 60, 90 and 180 min ]
  • Difference between drug and placebo between study days. [ Time Frame: Measurements at 60, 90 and 180 min ]

Secondary Outcome Measures:
  • Blood will be drawn to determination of guaifenesin in the serum. [ Time Frame: at baseline and every 30 min x8 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 13, 2009
First Posted: May 15, 2009
Last Update Posted: June 11, 2012
Last Verified: May 2012

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

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