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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
2mg, 4mg, 8mg
Creighton University Medical Center, Department of Pulmonology and Critical Care
Omaha, Nebraska, United States
Methacholine Responsiveness as Assessed by PC20,
PC20 is the concentration of methacholine at which patients had a decrease in Forced Expiratory Volume in one second (FEV1) of 20%
Time frame: patients were assessed at baseline and at 12 weeks
Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion
Fraction Exhaled Nitric oxide was measured on each visit prior to bronchoprovocation by chemiluminescence using an analyzer.
Time frame: patients were assessed at baseline and 12 weeks
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 in liters
Time frame: patients were assessed at baseline and 12 weeks
Forced Expiratory Volume in One Second (FEV1) Percent Predicted
Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.
Time frame: patients were assessed at baseline and 12 weeks
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