- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00557180
Examining the Link Between Obesity, Inflammation, and Response to Asthma Medications
Obesity, Inflammation and Response to Therapy in Asthma - Ancillary to Asthma Clinical Research Network (ACRN) Trials
Study Overview
Status
Intervention / Treatment
Detailed Description
Asthma affects 20 million people in the United States. It can be caused by many factors, including exposure to tobacco smoke, infections, and other allergens. Recent research suggests that there may be a relationship between obesity and asthma. It is not fully understood how these two conditions are linked, but inflammation may play a role. Obesity-related inflammation may increase the risk of airway inflammation, thereby elevating the risk of developing asthma. Increased inflammation related to obesity may also reduce the effectiveness of inhaled steroid asthma medications, including glucocorticoids. Compared with people of normal weight, people who are overweight or obese may have a higher risk of developing glucocorticoid insensitivity, resulting in intolerance to glucocorticoid medications. The purpose of this study is to examine the effect that obesity has on glucocorticoid insensitivity and inflammation. This study will also examine differences in the response to asthma steroid medications between people who are overweight or obese and those who are not.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92093
- University of California, San Diego
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Colorado
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Denver, Colorado, United States, 80206
- National Jewish Medical & Research Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham & Women'S Hospital
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Missouri
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Saint Louis, Missouri, United States, 63130
- Washington University
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Texas
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Galveston, Texas, United States, 77555
- University of Texas Medical Branch
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Wisconsin
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Madison, Wisconsin, United States, 53706
- University of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
BASALT
Participants in the ACRN BASALT study
|
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 Names:
|
TALC
Participants in the ACRN TALC study
|
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measures of lung function; asthma symptoms and exacerbations; quality of life; rescue medication usage; inflammation and oxidative stress biomarkers; and the effect these factors have on glucocorticoid insensitivity
Time Frame: Measured at Week 36 for BASALT participants and Week 46 for TALC participants
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Measured at Week 36 for BASALT participants and Week 46 for TALC participants
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: E. R. Sutherland, MD, MPH, National Jewish Medical & Research Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Obesity
- Inflammation
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Salmeterol Xinafoate
- Beclomethasone
- Tiotropium Bromide
- Bromides
Other Study ID Numbers
- 1423
- R01HL090982 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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