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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 4, 2008
Last Updated Date	September 22, 2008
Start Date ^ICMJE	January 2005
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00615706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics
Official Title ^ICMJE	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 ^ICMJE	Observational
Study Design ^ICMJE	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 ^ICMJE	Asthma
Intervention ^ICMJE	Other: No intervention no intervention
Study Group/Cohort (s)	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 ^ICMJE	Completed
Estimated Enrollment ^ICMJE	300
Completion Date	September 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00615706
Other Study ID Numbers ^ICMJE	345-2004, Emory IRB ID 345-2004
Has Data Monitoring Committee	No
Responsible Party	Fernando Holguin, MD, MPH, Emory University
Study Sponsor ^ICMJE	Emory University
Collaborators ^ICMJE	Critical Therapeutics
Investigators ^ICMJE	Not Provided
Information Provided By	Emory University
Verification Date	September 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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