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 : September 19, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Respiratory Infection | Drug: Mucinex Drug: Placebo | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Guaifenesin
Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
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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
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Drug: Placebo
Placebo given as 2 tablets |
- 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)
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, North Carolina | |
Center for Environmental Medicine, Asthma, and Lung Biology | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | William Bennett, PhD | University of North Carolina |
Responsible Party: | Reckitt Benckiser LLC |
ClinicalTrials.gov Identifier: | NCT01114581 |
Other Study ID Numbers: |
2010-MUC-01 |
First Posted: | May 3, 2010 Key Record Dates |
Results First Posted: | October 8, 2012 |
Last Update Posted: | September 19, 2018 |
Last Verified: | August 2018 |
Acute Respiratory Infection Mucociliary Cough Clearance Guaifenesin |
Infection Respiratory Tract Infections Respiratory Tract Diseases Phenylpropanolamine Guaifenesin 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 |