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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 : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Infection Drug: Mucinex Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Guaifenesin AUC(0-3) [ Time Frame: 3 hours following dose administration ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01114581     History of Changes
Other Study ID Numbers: 2010-MUC-01
First Posted: May 3, 2010    Key Record Dates
Results First Posted: October 8, 2012
Last Update Posted: November 6, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
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