Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (Glitz Asthma) (GLITZ)
|ClinicalTrials.gov Identifier: NCT00787644|
Recruitment Status : Terminated (new safety concerns which emerged about pioglitazone during the trial)
First Posted : November 7, 2008
Results First Posted : February 26, 2015
Last Update Posted : February 26, 2015
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 or disease||Intervention/treatment||Phase|
|Asthma Obesity||Drug: Pioglitazone Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||December 2013|
|Active Comparator: 1||
Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
|Placebo Comparator: 2||
Matching placebo (inert tablet)
- PC20 [ Time Frame: 12 weeks ]
Airway reactivity will be measured with methacholine challenge testing following ATS guidelines.
This is the concentration of methacholine that produces a 20% decrease in lung function (measured by forced expiratory volume in 1 second)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787644
|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|