Asthma Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Allergic 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:
Phase 1
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.
Phase II
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.
Phase III
Patients return for follow-up 1 month after stopping the medication or placebo to monitor
their asthma.
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. ;
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