Examining the Link Between Obesity, Inflammation, and Response to Asthma Medications
NCT ID: NCT00557180
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
33 participants
OBSERVATIONAL
2007-10-31
2011-02-28
Brief Summary
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Detailed Description
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This study will use previously collected data from participants in two clinical trials of the NHLBI-funded Asthma Clinical Research Network (ACRN): the Best Adjustment Strategy for Asthma in Long Term (BASALT) study (NCT00495157) and the Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC) study. There will be no additional study visits specifically for this study. Researchers will examine blood samples collected at participants' first BASALT or TALC study visit to analyze levels of inflammation biomarkers (including tumor necrosis factor-alpha \[TNF-α\], interleukin-6 \[IL-6\], and leptin) and proinflammatory cytokines levels, which influence glucocorticoid insensitivity. Additional BASALT and TALC study data, including lung function, asthma symptoms, and asthma exacerbations, will also be analyzed.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BASALT
Participants in the ACRN BASALT study
Beclomethasone dipropionate HFA
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
TALC
Participants in the ACRN TALC study
Tiotropium bromide
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
Salmeterol xinafoate
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
Interventions
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Beclomethasone dipropionate HFA
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
Tiotropium bromide
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
Salmeterol xinafoate
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Participation in either the BASALT or TALC studies of the Asthma Clinical Research Network. Inclusion and exclusion criteria are as determined by those studies, NCT00495157, NCT00565266.
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Jewish Health
OTHER
Responsible Party
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Principal Investigators
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E. R. Sutherland, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
National Jewish Medical & Research Center
Locations
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University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
National Jewish Medical & Research Center
Denver, Colorado, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Sutherland ER, Goleva E, Jackson LP, Stevens AD, Leung DY. Vitamin D levels, lung function, and steroid response in adult asthma. Am J Respir Crit Care Med. 2010 Apr 1;181(7):699-704. doi: 10.1164/rccm.200911-1710OC. Epub 2010 Jan 14.
Related Links
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Click here for the Asthma Clinical Research Network (ACRN) Web site.
Other Identifiers
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1423
Identifier Type: -
Identifier Source: org_study_id
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