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Sponsors and Collaborators: |
University of Vermont American Lung Association University of Pittsburgh |
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Information provided by: | University of Vermont |
ClinicalTrials.gov Identifier: | NCT00787644 |
Asthmatics who are significantly overweight tend to have more severe symptoms, more flare ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.
Researchers believe this occurs because excess adipose tissue (fat) in the bosy can cause higher-than-normal levels of leptin and lower levels of adiponectin in the blood.
The researchers of this study are testing a medication called pioglitazone in overweight asthmatics because they believe it can help regulate leptin and adiponectin and that this may improve symptoms of asthma.
Condition | Intervention | Phase |
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Asthma |
Drug: Pioglitazone Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics. (The GLITZ Asthma Study) |
Estimated Enrollment: | 40 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Pioglitazone
Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
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2: Placebo Comparator |
Drug: Placebo
Matching placebo (inert tablet)
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Participants in this study will be randomly assigned (like the flip of a coin) to pioglitazone or placebo (an inactive pill). They will be given study medication to take every day for 12 weeks (3 months).
Participants will complete a number of asthma-related questionnaires and a variety of pulmonary function tests. Participants will undergo physical exams, an electrocardiogram, and blood sampling to measure leptin, adiponectin, markers of inflammation, blood cell counts, glucose levels, BNP hormone levels, and liver function.
To monitor participants throughout the study, follow-up visits will be done at 2, 6, and 12 weeks after starting study drug. At these visits many of the pulmonary function tests and questionnaires will be repeated.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laurianne V. Griffes, AS, BA | (802) 847-2193 | laurianne.griffes@vtmednet.org |
United States, Vermont | |
The Vermont Lung Center at the University of Vermont | |
Colchester, Vermont, United States, 05446 |
Principal Investigator: | Anne E Dixon, MD | The Vermont Lung Center at the University of Vermont |
Responsible Party: | The Vermont Lung Center at the University of Vermont ( Anne E. Dixon, M.D. ) |
Study ID Numbers: | GLITZ Asthma |
Study First Received: | November 5, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00787644 |
Health Authority: | United States: Food and Drug Administration |
Asthma Asthmatics Adipose Tissue Pioglitazone Actos Obesity Exacerbation Fat |
Overweight Leptin Adiponectin Wheezing Vermont Pulmonary Lung |
Obesity Hypersensitivity Lung Diseases, Obstructive Pioglitazone Respiratory Tract Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Overweight Respiratory Hypersensitivity |
Hypoglycemic Agents Immune System Diseases Bronchial Diseases Physiological Effects of Drugs Pharmacologic Actions |