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
  Purpose

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 Intervention
Asthma
Other: No intervention

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Emory University:

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 300
Study Start Date: January 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Asthmatics
Other: No intervention
no intervention
2
Healthy volunteers (without asthma)
Other: No intervention
no intervention

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Asthmatics and healthy volunteers

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615706

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

No publications provided

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
Study First Received: February 4, 2008
Last Updated: September 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
asthma, inhaled corticosteroids

ClinicalTrials.gov processed this record on October 29, 2014