Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics (ABI/BALA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615706
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : September 23, 2008
Critical Therapeutics
Information provided by:
Emory University

February 4, 2008
February 14, 2008
September 23, 2008
January 2005
September 2008   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00615706 on Archive Site
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Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics
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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.

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Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Serum, urine, DNA, exhaled breath condensate. For substudy participants, bronchoalveolar lavage samples.
Non-Probability Sample
Asthmatics and healthy volunteers
Other: No intervention
no intervention
  • 1
    Intervention: Other: No intervention
  • 2
    Healthy volunteers (without asthma)
    Intervention: Other: No intervention
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Emory IRB ID 345-2004
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Fernando Holguin, MD, MPH, Emory University
Emory University
Critical Therapeutics
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Emory University
September 2008