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Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics

NCT ID: NCT00615706

Last Updated: 2008-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-09-30

Brief Summary

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In the United States there has been a dramatic increase in the number of people who are obese and in the number of people who have asthma. Both are considered serious public health concerns. Several studies have shown that becoming obese or overweight can increase the risk of developing asthma or can make asthma symptoms more severe and difficult to control. How obesity affects asthma is not fully understood. This research study will examine whether obesity affects the amount of inflammation that is present in the lungs of people with asthma, and will also examine whether obesity leads to narrow and stiff airways.

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 research study includes optional genetic and bronchoscopy substudies.

Detailed Description

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Conditions

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Asthma

Keywords

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asthma, inhaled corticosteroids

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Asthmatics

No intervention

Intervention Type OTHER

no intervention

2

Healthy volunteers (without asthma)

No intervention

Intervention Type OTHER

no intervention

Interventions

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No intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults 18 to 70 years of age
* If asthmatic, currently taking a short acting beta agonist and an inhaled corticosteroid
* Never smoked or limited smoking history

Exclusion Criteria

* Current upper respiratory illness (other than asthma)
* Illegal drug use within past month
* Consumption of more than 6 alcoholic drinks per week
* Active, pronounced rhinitis or sinusitis
* Pregnancy
* Currently taking oral steroids or steroid injection over the past month
* Asthma exacerbation over the past month
* Certain medical illnesses
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Critical Therapeutics

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Emory University

Locations

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Emory University, Emory Crawford Long Hospital, Clinical Research Center

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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Emory IRB ID 345-2004

Identifier Type: -

Identifier Source: secondary_id

345-2004

Identifier Type: -

Identifier Source: org_study_id