A Pilot Evaluation of the Impact of Alcohol Use on Airway... | NCT00615407

Studies
A Pilot Evaluation of the Impact of Alcohol Use on Airway Inflammation and Mechanics in Asthmatics

NCT00615407

Sponsor

Emory University

Status

Withdrawn

Last Update Posted

Nov 18, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Not provided

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Dr. Holguin is relocating.

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 4, 2008

First Submission Date that Met QC Criteria

Feb 4, 2008

First Posted Date

Feb 14, 2008Estimated

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

Nov 14, 2013

Last Update Posted Date

Nov 18, 2013Estimated

Name	Class
National Institutes of Health (NIH)	NIH

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

Since 1980, the number of people in the United States diagnosed with asthma has increased dramatically. Studying what causes and triggers asthma is an important part of understanding and subsequently managing this disease. Although some have suggested that alcohol consumption may affect asthma, little is known about how consistent alcohol use affects the amount of inflammation present in the lungs and whether consistent alcohol use makes the airways more narrow and stiff.

Participation in this study involves 2 visits in order to complete questionnaires, various pulmonary function tests, as well as the collection of blood, urine, and exhaled breath condensate specimens.

This study includes optional genetic and bronchoscopy substudies.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alcohol Drinkers		Asthmatics who consume 3 or more alcoholic beverages per day (on average)
Non Drinkers		Asthmatics who do not drink alcohol or consume less than or equal to 2 alcoholic beverages per month

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurements of airway oxidative stress (increased GSSG/GS, and RNS/NO ratios and higher exhaled 8-isoprostanes levels)		single timepoint

Secondary Outcomes

Measure	Description	Time Frame
Measurements of lung function (spirometry, response to methacholine challenge, and impulse oscillometry).		single timepoint
Asthma symptoms and control through standard asthma questionnaires		single timepoint

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 65 years of age
Literate in English (i.e., read study materials at 6th grade level) so as to understand, and complete the ratings scales and questionnaires accurately
Physician-diagnosed asthma requiring treatment in the past year with a post bronchodilator FEV1/FVC >0.70 and at least 12% reversibility after bronchodilator usage
Alcohol usage groups: 1) those who rarely or who do not drink alcohol (≤2 drinks per month); or 2) those who drink 3 or more alcoholic beverages per day on average

Exclusion Criteria:

Social drinkers (>2 drinks in a month but <3 drinks per day)
Asthma exacerbation within the past month
Current upper respiratory infection
Active allergies with uncontrolled symptoms
Current DSM-IV diagnosis of illicit substance dependence (not alcohol)
History of serious pulmonary problems other than asthma
Other significant non-pulmonary comorbidities
Pregnancy or currently lactating
Daily use of Prednisone or other corticosteroids
Tobacco smoking within the past year or >10 life-time pack-years of smoking
Positive breath alcohol level at the time of the study assessments
Positive urine cotinine test at enrollment (indicates nicotine usage)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

For this study, 40 non-smoking adults with asthma will be recruited-50% will be non-drinking and 50% will be heavy alcohol users (≥3 standard drinks/day on average).

Sampling Method

Non-Probability Sample

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases