The Use of Rosiglitazone to Treat Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: rosiglitazone
Intervention description: 2mg, 4mg, 8mg
Intervention MeSH terms: Rosiglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Asthma; Avandia

Summary:

      Asthma is a common chronic disease characterized by airway inflammation and
      bronchoconstriction. This study utilizes the drug rosiglitazone (Avandia)to treat the effects
      of airway inflammation in patients with asthma.

      The study will be conducted on 14 adult steroid naive patients with asthma. Patients with
      qualifying pulmonary function testing values will be eligible for enrollment. Enrolled
      subjects will be treated with rosiglitazone orally at 2mg dose for 4 weeks. Patients will be
      reassessed and dosing will increase in 4 week increments up to 8mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to comprehend and grant a witnessed, written informed consent

          -  Must be greater than 19 years old

          -  Must be able to swallow a tablet

          -  Female participants must have a negative urine pregnancy test at visit 1 and
             throughout duration of the study

          -  Must have a history of physician diagnosed asthma

          -  Must have a baseline FEV1 >60% predicted

          -  Must be able to perform pulmonary function testing

          -  Must have methacholine-induced decrease in FEV1 of 20%

          -  Must be capable of withholding medications that may affect the methacholine challenge
             test

          -  Must be able to withstand a 30 day washout period for all inhaled corticosteroids

          -  Must be able to attend all office visits, 4 weeks apart for 12 weeks. Each visit will
             last approximately 2-3 hours

        Exclusion Criteria:

          -  Age 18 or younger

          -  FEV1 <60% predicted value

          -  History or presence of significant renal, hepatic,neurologic, cardiovascular,
             hematologic, cerebrovascular, respiratory, endocrine, gastrointestinal, or collagen
             vascular disorder that in the Investigator's opinion could interfere with the study or
             require medical attention that would interfere with the study.

          -  History of cancer other than basal cell skin cancer

          -  History of hypoglycemia

          -  Current smokers, greater than 10 pack year history, or patients quitting less than 1
             year prior to screening

          -  History within the past year of excessive alcohol intake or drug addiction

          -  History of respiratory infection requiring treatment with an antibiotic within 2 week
             prior to visit 1

          -  Chronic intermittent use of inhaled, oral, intra-muscular, topical or intravenous
             corticosteroids within 4 weeks of visit 1

          -  Inability to perform consistent spirometry or nitric oxide exhalation

          -  Treatment with an experimental, non-approved drug, or investigational drug within the
             past 30 days

          -  Known hypersensitivity to rosiglitazone

          -  History of noncompliance to medical regimens and participants who are considered to be
             potentially unreliable