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OpenTrials
Completed

NCT Number: NCT00902707

Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung

The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.

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Key information

Conditions

Mucociliary Clearance

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • Non smoker
  • BMI 19-29
  • Normal lung function

Exclusion criteria

  • Pregnant
  • Smokers
  • Any illness

Treatment and study plan

Mucinex 1200mg

Drug

Compared to Placebo

Placebo

Drug

Compare to active Mucinex

Primary outcomes

  1. Difference between drug and placebo in the percentage of particles cleared from the lung.

    Time frame: Measurements at 60, 90 and 180 min

  2. Difference between drug and placebo as an estimate of small airway clearance.

    Time frame: Measurements at 60, 90 and 180 min

  3. Difference between drug and placebo between study days.

    Time frame: Measurements at 60, 90 and 180 min

Secondary outcomes

  1. Blood will be drawn to determination of guaifenesin in the serum.

    Time frame: at baseline and every 30 min x8

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Reckitt Benckiser Inc.

Registry information

Official study title

An Open-Label, 2-way Crossover Placebo-Controlled , Radio-Labeled Tracer Study Evaluating the Effect of MUCINEX® 1200 mg on Mucociliary and Cough Clearance From The Human Lung In Healthy, Non-Smoking Adults

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 15, 2009
Registry last updated
Jun 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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