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

This study has been completed.
Sponsor:
Collaborator:
Critical Therapeutics
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00615706
First received: February 4, 2008
Last updated: September 22, 2008
Last verified: September 2008

February 4, 2008
September 22, 2008
January 2005
September 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00615706 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics
Not Provided

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.

Not Provided
Observational
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Serum, urine, DNA, exhaled breath condensate. For substudy participants, bronchoalveolar lavage samples.

Non-Probability Sample

Asthmatics and healthy volunteers

Asthma
Other: No intervention
no intervention
  • 1
    Asthmatics
    Intervention: Other: No intervention
  • 2
    Healthy volunteers (without asthma)
    Intervention: Other: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00615706
345-2004, Emory IRB ID 345-2004
No
Fernando Holguin, MD, MPH, Emory University
Emory University
Critical Therapeutics
Not Provided
Emory University
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP