The Use of Rosiglitazone to Treat Asthma
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|ClinicalTrials.gov Identifier: NCT00614874|
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : September 2, 2011
Last Update Posted : September 2, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: rosiglitazone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of the PPARy Agonist Rosiglitazone on Airway Hyperreactivity|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||March 2010|
Subjects took rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
2mg, 4mg, 8mg
- Methacholine Responsiveness as Assessed by PC20, [ Time Frame: patients were assessed at baseline and at 12 weeks ]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 ]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 ]FEV1 in liters
- Forced Expiratory Volume in One Second (FEV1) Percent Predicted [ Time Frame: patients were assessed at baseline and 12 weeks ]Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614874
|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|