Status:
COMPLETED
Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics
Lead Sponsor:
Fernando Holguin
Collaborating Sponsors:
Takeda
University of Vermont
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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 beli...
Detailed Description
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 mon...
Eligibility Criteria
Inclusion
- Asthma diagnosed by a physician at least 1 year prior to study enrollment
- Poorly-controlled asthma at study enrollment
- Non smokers (stopped smoking at least 1 year ago) and limited life-time history of smoking
- Body mass index 30-60
- Responds to methacholine challenge test with PC20 of \<16 mg/ml
- On a stable dose of inhaled corticosteroid for at least 4 weeks prior to study entry
- FEV1 \>60% predicted
- Able to obtain weekly weights at home
Exclusion
- Systemic steroids within the past 4 weeks
- Lung pathology other than asthma
- Other significant non-pulmonary co-morbidities such as: coronary artery disease, peripheral vascular disease, cerebrovascular disease, congestive heart failure with an ejection fraction \<50%, liver disease or elevated liver enzymes at baseline, malignancy (excluding non-melanoma skin cancers), AIDS, renal failure with serum creatinine \>3.0, or disorders requiring steroid treatment such as vasculitis, lupus, rheumatoid arthritis
- B-type natriuretic peptide (BNP) \>400 pg/mL
- Pregnant or lactating
- Currently taking a beta blocker, a CYP2C8 inhibitor or inducer such as gemfibrozil or rifampin, a TZD (thiazolidinedione), or allergic to TZD
- Taking antioxidants or nutritional supplements (stable dose of calcium, vitamin D, or multivitamin is OK)
- Illicit drug use within the past year
- Current/active upper respiratory infection (if active URI, wait until asymptomatic for 1 week to enroll)
- Asthma exacerbation within the past 4 weeks (includes ER, urgent care, or hospital visits due to asthma resulting in an increase in asthma-related medications)
- Undergoing evaluation for sleep apnea, or plans to institute treatment for sleep apnea (patients on a stable treatment regimen for sleep apnea for the last 3 months will be allowed to participate)
- Clinically significant abnormalities present on screening 12-lead electrocardiogram
- Women of childbearing potential using oral contraceptives who are not willing to use a second method of contraception during the study
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00634036
Start Date
October 1 2009
End Date
April 1 2012
Last Update
July 19 2017
Active Locations (2)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
2
University of Vermont
Colchester, Vermont, United States, 05446