Pioglitazone Hydrochloride (Actos(Registered Trademark)) to Treat Asthma
This study will test whether pioglitazone hydrochloride (Actos (Registered Trademark) Registered Trademark) is effective for treating patients with asthma who do not respond to standard therapy. Experiments have shown that this drug, which is used to treat patients with diabetes, may be effective for treating asthma.
People between 18 and 75 years of age who have had asthma for at least a1 year and whose symptoms are not well controlled with high doses of inhaled corticosteroids with or without long-acting bronchodilators may be eligible for this study. Candidates are screened with breathing tests, an allergy skin test, chest x-ray, electrocardiogram (ECG), echocardiogram (ultrasound test of the heart), blood tests, and DEXA scan (an x-ray to measure bone thickness) to make sure they are eligible for the study.
Then, participants undergo tests and procedures in the following study phases:
Participants are given a device to measure and record their lung function and asthma symptoms at home each morning and night for 4 weeks before starting the study medication. Lung function is also measured at clinic visits before and after inhaling a bronchodilator medicine. Before starting the study medication, participants have a sputum induction (sputum collection test). For this test, the participants inhale a salt-water mist and are asked to collect sputum into a plastic cup.
Participants are randomly selected to receive either pioglitazone hydrochloride or placebo (a look-alike pill with no active ingredient) once a day for 10 weeks. They return to the clinic after 2 weeks to repeat the tests done in Phase 1 and to monitor any reactions to the study drug or placebo. If there are no problems, the amount of medication is increased once, and then they return for follow-up evaluations every 2 weeks for 8 weeks. Pulmonary function tests, sputum collection and DEXA scan are repeated after 10 weeks on medication.
Patients return for follow-up 1 month after stopping the medication or placebo to monitor their asthma.
Drug: Pioglitazone Hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Allergic Asthma|
- The change in post-bronchodilator FEV1. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Airway inflammation, Airflow Obstruction, Airway Hyperreactivity, Asthma Symptoms, Rate of mild exacerbation, Rate of severe exacerbation, Asthma Quality-of-life, Blood Eosinophil Counts, Serum IgE and Exhaled Nitric Oxide Levels. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||October 2009|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Drug: Pioglitazone Hydrochloride
New therapies are needed for patients with asthma who are suboptimally controlled by standard measures. Pioglitazone hydrochloride (Actos [R]) is a highly selective and potent agonist for the peroxisome proliferator-activated receptor-gamma (PPAR gamma). Studies in murine models of allergic asthma have shown that PPAR gamma-agonists down-regulate allergen-mediated airway inflammation and airway hyperresponsiveness. This protocol is a randomized, placebo-controlled, double-blind, parallel-group (phase II) pilot study of the efficacy and safety of pioglitazone for the treatment of patients with allergic asthma and reversible airflow obstruction who are persistently symptomatic despite therapy with high doses of inhaled corticosteroids with or without long-acting Beta 2-agonists. The primary end-point for this study will be the change in airflow obstruction, as measured by the post-bronchodilator FEV1. Secondary end-points will include indices of airway inflammation, airflow obstruction, airway hyperreactivity, and asthma symptoms.
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, Virginia|
|Falls Church, Virginia, United States, 22046|