Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics
Condition: Asthma
MeSH terms: Asthma
Intervention: pioglitazone; placebo
Intervention description: pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months); matching placebo (inert tablet)
Intervention MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Asthma; obesity; exacerbation; asthmatics; fat; overweight; adipose tissue; leptin; adiponectin; pioglitazone; Actos; wheezing; Pittsburgh; Pennsylvania; pulmonary; lung

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.
    

Eligibility 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