Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fernando Holguin; University of Pittsburgh
• Collaborators: Takeda; University of Vermont
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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