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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01114581

First Posted: May 3, 2010

Last Update Posted: October 8, 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.

Information provided by:

Reckitt Benckiser LLC

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 Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

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 ]
Percentage of inhaled radioactive tracer (Ave180Clear)

Secondary Outcome Measures:

Guaifenesin AUC(0-3) [ Time Frame: 3 hours following dose administration ]
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 ]


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

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 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

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

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
First Submitted:	April 28, 2010
First Posted:	May 3, 2010
Results First Submitted:	March 15, 2012
Results First Posted:	October 8, 2012
Last Update Posted:	October 8, 2012
Last Verified:	September 2012

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

To Top