NCT00614874

The Use of Rosiglitazone to Treat Asthma

The Effects of the PPARy Agonist Rosiglitazone on Airway Hyperreactivity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Creighton University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed description

The current standard-of-care utilizes corticosteroids to down-regulate the inflammatory state in patients with asthma. However, corticosteroids have many side effects and are not universally effective. New safe anti-inflammatory agents are needed to help modulate the disease. Peroxisome proliferator-activated receptor agonists are widely used to manage diabetes mellitus, another common chronic disease. These agents have been study models and have been shown to have anti-inflammatory effects in lung tissue. Case reports have noted improvement in asthma symptoms in patients being treated with these agents. These agents are ideally placed for human research given their long record of safe use in the treatment of type 2 diabetes.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	rosiglitazone	2mg, 4mg, 8mg

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2008-02-13
• Last updated: 2011-09-02
• Results posted: 2011-09-02

Locations

1 site across 1 country: United States