Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection - Full Text View

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

Drug Information available for: Guaifenesin Phenylpropanolamine hydrochloride Triaminic Phenylpropanolamine

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 (Adult)
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

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

Bennett WD, Kala A, Duckworth H, Zeman KL, Wu J, Henderson A, Yopp M, Rubin BK. Effect of a single 1200 Mg dose of Mucinex® on mucociliary and cough clearance during an acute respiratory tract infection. Respir Med. 2015 Nov;109(11):1476-83. doi: 10.1016/j.rmed.2015.09.017. Epub 2015 Oct 9.


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:


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

ClinicalTrials.gov processed this record on September 30, 2016

Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection (MCC/CC)