Evaluating the Effect of Mucinex® 1200 mg on Mucociliary... | NCT00902707

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

NCT00902707

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Jun 11, 2012Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Mucociliary Clearance

Interventions

Mucinex 1200mg
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

May 13, 2009

First Submission Date that Met QC Criteria

May 14, 2009

First Posted Date

May 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2012

Last Update Posted Date

Jun 11, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

William Bennett, PhD, Professor of Medicine, University of North Carolina, Chapel HillPrincipal Investigator

Lead Sponsor

University of North Carolina, Chapel HillOTHER

Collaborators

Name	Class
Reckitt Benckiser Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mucinex 1200mg	Experimental	Pill	Drug: Mucinex 1200mg
Placebo	Placebo Comparator	Pill	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mucinex 1200mg	Drug	Compared to Placebo	Mucinex 1200mg
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Blood will be drawn to determination of guaifenesin in the serum.		at baseline and every 30 min x8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
Non smoker
BMI 19-29
Normal lung function

Exclusion Criteria:

Pregnant
Smokers
Any illness

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Bennett, PhD	University of North Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UNC Center for Environmental Medicine, Asthma and Lung Biology		Chapel Hill	North Carolina	27599	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000111	Acetylcysteine

Ancestor Terms

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided