A Phase 2 interventional study of Pioglitazone and Placebo in Asthma and Obesity, sponsored by University of Vermont. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-02-26.
Sponsored by University of Vermont · Phase 2, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 28 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Pioglitazone
Drug: Placebo
Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
Matching placebo (inert tablet)
PC20
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)
Time frame: 12 weeks
| Milestone | 1. Pioglitazone | 2. Placebo |
|---|---|---|
| Started | 12 | 11 |
| Completed | 10 | 9 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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)
| mg/ml | 1. Pioglitazone | 2. Placebo |
|---|---|---|
| PC20 | 5.08 ± 7.42 | 2.37 ± 15.22 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1. Pioglitazone | — | 0/12 (0%) | 0/12 (0%) |
| 2. Placebo | — | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | 1. Pioglitazone | 2. Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 11 | 23 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | 1. Pioglitazone | 2. Placebo | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 5 | 3 | 8 |
| Race (NIH/OMB)(Participants) | 1. Pioglitazone | 2. Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 8 | 9 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | 1. Pioglitazone | 2. Placebo | Total |
|---|---|---|---|
| United States | 12 | 11 | 23 |
| PC20(mg/ml) | 1. Pioglitazone | 2. Placebo | Total |
|---|---|---|---|
| Median | 1.60 ± 5.91 | 1.99 ± 3.08 | 1.90 ± 3.08 |
This study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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University of Vermont