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

Tracking Information
First Submitted Date	February 4, 2008
First Posted Date	February 14, 2008
Last Update Posted Date	September 23, 2008
Study Start Date	January 2005
Actual Primary Completion Date	September 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00615706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics
Official Title	Not Provided
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: Serum, urine, DNA, exhaled breath condensate. For substudy participants, bronchoalveolar lavage samples.
Sampling Method	Non-Probability Sample
Study Population	Asthmatics and healthy volunteers
Condition	Asthma
Intervention	Other: No intervention; no intervention
Study Groups/Cohorts	1 Asthmatics Intervention: Other: No intervention; 2 Healthy volunteers (without asthma) Intervention: Other: No intervention
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Estimated Enrollment; (submitted: February 4, 2008)	300
Original Estimated Enrollment	Same as current
Actual Study Completion Date	September 2008
Actual Primary Completion Date	September 2008 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00615706
Other Study ID Numbers	345-2004; Emory IRB ID 345-2004
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Fernando Holguin, MD, MPH, Emory University
Study Sponsor	Emory University
Collaborators	Critical Therapeutics
Investigators	Not Provided
PRS Account	Emory University
Verification Date	September 2008