The Use of Rosiglitazone to Treat Asthma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effects of the PPARy Agonist Rosiglitazone on Airway Hyperreactivity|
- Methacholine Responsiveness as Assessed by PC20, [ Time Frame: patients were assessed at baseline and at 12 weeks ] [ Designated as safety issue: No ]PC20 is the concentration of methacholine at which patients had a decrease in Forced Expiratory Volume in one second (FEV1) of 20%
- Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion [ Time Frame: patients were assessed at baseline and 12 weeks ] [ Designated as safety issue: No ]Fraction Exhaled Nitric oxide was measured on each visit prior to bronchoprovocation by chemiluminescence using an analyzer.
- Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: patients were assessed at baseline and 12 weeks ] [ Designated as safety issue: No ]FEV1 in liters
- Forced Expiratory Volume in One Second (FEV1) Percent Predicted [ Time Frame: patients were assessed at baseline and 12 weeks ] [ Designated as safety issue: No ]Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.
|Study Start Date:||December 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Subjects took rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
2mg, 4mg, 8mg
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.
|United States, Nebraska|
|Creighton University Medical Center, Department of Pulmonology and Critical Care|
|Omaha, Nebraska, United States, 68131|
|Principal Investigator:||Tammy Wichman, MD||Creighton University Medical Center|