NCT00902707

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 11, 2012

Status Verified

May 1, 2012

Enrollment Period

3 years

First QC Date

May 13, 2009

Last Update Submit

June 8, 2012

Conditions

Mucociliary Clearance

Keywords

healthy nonsmokers

Outcome Measures

Primary Outcomes (3)

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

    Measurements at 60, 90 and 180 min

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

    Measurements at 60, 90 and 180 min

  • Difference between drug and placebo between study days.

    Measurements at 60, 90 and 180 min

Secondary Outcomes (1)

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

    at baseline and every 30 min x8

Study Arms (2)

Mucinex 1200mg

EXPERIMENTAL

Pill

Drug: Mucinex 1200mg

Placebo

PLACEBO COMPARATOR

Pill

Drug: Placebo

Interventions

Mucinex 1200mgDRUG

Compared to Placebo

Mucinex 1200mg
PlaceboDRUG

Compare to active Mucinex

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnant
  • Smokers
  • Any illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • William Bennett, PhD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 15, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 11, 2012

Record last verified: 2012-05

Locations

US(1)