A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Severe, Refractory Asthma
- Individuals who have severe asthma that is not easily controlled by current treatments are in need of new treatments to prevent potentially life-threatening asthma attacks. Experiments in mice have found that a medication called pioglitazone hydrochloride (Actos ), which is used to treat patients with diabetes, may be effective for treating severe asthma. Researchers are interested in determining whether Actos is effective in improving the quality of life in subjects with severe asthma who continue to have symptoms despite maximum standard medical therapy.
- To assess the effectiveness of pioglitazone hydrochloride as a treatment for patients with severe asthma that is not controlled by standard treatments.
- Individuals between 18 and 75 years of age who have been diagnosed with and treated for severe asthma for at least 1 year.
- Potential participants will have a screening visit to determine eligibility for the study. The visit will involve breathing tests, chest x rays, heart and lung monitoring, and blood tests.
- Eligible participants will have a full medical history and will answer a series of questionnaires about their quality of life with asthma.
- Phase 1: Patients will record lung function and asthma symptoms morning and evening for 4 weeks. At the end of this period, patients will be evaluated with breathing, allergy, and blood tests, as well as questionnaires. Patients will also provide a sputum sample.
- Phase 2: Patients will receive regular doses of either pioglitazone hydrochloride or a placebo for 16 weeks. Patients will return to the National Institutes of Health every 4 weeks for tests.
- Phase 3: Wash-out period without study drugs for 4 weeks, similar to Phase 1.
- Phase 4: Patients will receive regular doses of either pioglitazone hydrochloride or a placebo for 16 weeks. Patients who received placebo will be given the study drug, and vice versa. Patients will return to the National Institutes of Health every 4 weeks for tests.
- Phase 5: Medications will be stopped, and patients will return to the National Institutes of Health 4 weeks later for final tests.
|Severe, Refractory Asthma Airway Inflammation Airflow Obstruction||Drug: Pioglitazone||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
|Official Title:||A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Severe, Refractory Asthma|
- Quality of life as determined by the validated Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: 3 years ]
- Airway inflammation, airflow obstruction, asthma symptoms, asthma exacerbations, blood eosinophil counts, serum IgE and exhaled nitric oxide levels [ Time Frame: 3 years ]
|Study Start Date:||September 23, 2009|
|Study Completion Date:||June 24, 2016|
|Primary Completion Date:||June 24, 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994175
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, Virginia|
|INOVA Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Stewart J Levine, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|