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

Information source: Reckitt Benckiser Inc.
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Respiratory Infection

Intervention: Mucinex (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Reckitt Benckiser Inc.

Official(s) and/or principal investigator(s):
William Bennett, PhD, Principal Investigator, Affiliation: University of North Carolina

Overall contact:
Aline Kala, RN, Phone: 919.843.9108, Email: kala_aline@med.unc.edu

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.

Clinical Details

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Assess biological effect between Mucinex 1200mg and placebo on mucociliary and cough clearance during an acute RTI by quantifying rate of removal from the lung of inhaled radioactive tracer particles in otherwise healthy, non-smoking adults.

Secondary outcome:

Blood will be drawn to determine amount of Mucinex in the serum.

Assess sputum properties (objective measures) and symptoms (subjective measures) after treatment with Mucinex or placebo.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Aline Kala, RN, Phone: 919.843.9108, Email: kala_aline@med.unc.edu

Center for Environmental Medicine, Asthma, and Lung Biology, Chapel Hill, North Carolina 27599, United States; Recruiting
Aline Kala, RN, Phone: 919-843-9108, Email: alinkala@med.unc.edu
William Bennett, PhD, Principal Investigator
Ashley Henderson, MD, Sub-Investigator
Kirby Zeman, PhD, Sub-Investigator
Jihong Wu, MD, Sub-Investigator
Michelle Hernandez, MD, Sub-Investigator
Anne W Brown, MD, Sub-Investigator
Additional Information

Starting date: April 2010
Last updated: April 29, 2010

Page last updated: October 04, 2010

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