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

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ClinicalTrials.gov Identifier: NCT00615706
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : September 23, 2008
Critical Therapeutics
Information provided by:
Emory University

Brief Summary:

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.

Condition or disease Intervention/treatment
Asthma Other: No intervention

Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Cross-Sectional
Study Start Date : January 2005
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Group/Cohort Intervention/treatment
Other: No intervention
no intervention
Healthy volunteers (without asthma)
Other: No intervention
no intervention

Biospecimen Retention:   Samples With DNA
Serum, urine, DNA, exhaled breath condensate. For substudy participants, bronchoalveolar lavage samples.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Asthmatics and healthy volunteers

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615706

United States, Georgia
Emory University, Emory Crawford Long Hospital, Clinical Research Center
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Critical Therapeutics

Responsible Party: Fernando Holguin, MD, MPH, Emory University
ClinicalTrials.gov Identifier: NCT00615706     History of Changes
Other Study ID Numbers: 345-2004
Emory IRB ID 345-2004
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: September 23, 2008
Last Verified: September 2008

Keywords provided by Emory University:
asthma, inhaled corticosteroids