Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (GLITZ Asthma)
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|ClinicalTrials.gov Identifier: NCT00634036|
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : July 19, 2017
Last Update Posted : July 19, 2017
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 body can cause higher-than-normal levels of leptin and lower-than-normal 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||Drug: pioglitazone Drug: placebo||Phase 2|
Participants in this study will be randomly assigned (like the flip of a coin) to pioglitazone or a placebo (an inactive pill). They will be given study medication to take everyday 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 :||23 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|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
|Active Comparator: 1||
pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
Other Name: Actos
|Placebo Comparator: 2||
matching placebo (inert tablet)
- Airway Reactivity [ Time Frame: 12 weeks ]Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test. PC20= Methacholine dose at wich the FEV1 deops by > 20% from pre-methacholine baseline values.
- FEV1 % Predicted [ Time Frame: 12 weeks ]
- Juniper Asthma Control Questionnaire [ Time Frame: 12 weeks ]The Juniper Asthma Control Questionnaire is a validated scale ranging from 0 to 6. Higher scores represent poorer asthma control. Values > 1.5 are compatible with poorly controlled asthma
- Exhaled Nitric Oxide Ppb [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634036
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Vermont|
|University of Vermont|
|Colchester, Vermont, United States, 05446|
|Principal Investigator:||Fernando Holguin, MD, MPH||University of Pittsburgh|
|Principal Investigator:||Anne E. Dixon, MD||University of Vermont|