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Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics (ABI/BALA)
| 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. |
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| 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. |
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| Sampling Method | Non-Probability Sample | ||
| Study Population | Asthmatics and healthy volunteers | ||
| Condition ICMJE | Asthma | ||
| Intervention ICMJE | Other: No intervention
no intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| 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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 70 Years (Adult, Senior) | ||
| Accepts Healthy Volunteers | Yes | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00615706 | ||
| Other Study ID Numbers ICMJE | 345-2004 Emory IRB ID 345-2004 |
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| 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 ICMJE | Emory University | ||
| Collaborators ICMJE | Critical Therapeutics | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Emory University | ||
| Verification Date | September 2008 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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