The Use of Rosiglitazone to Treat Asthma

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Creighton University
• Treatments: Rosiglitazone

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