Protocol Number: 08-H-0047
People between 18 and 75 years of age who have had asthma for at least 1 year and whose symptoms are not well controlled with medium to high doses of inhaled corticosteroids plus long-acting bronchodilators may be eligible for this study. Candidates are screened with blood and urine tests, breathing tests, an allergy skin test, chest x-ray, electrocardiogram (ECG) and echocardiogram (ultrasound test of the heart). Participants undergo tests and procedures in two study phases, as follows: Phase I 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 are admitted to the hospital for fiberoptic bronchoscopy and lavage (rinse). For this test, plastic tube is placed in a vein to give medications. The mouth, throat and nose are numbed with lidocaine and the bronchoscope (a thin flexible tube) is placed through the nose or mouth into the lung airways to examine them. A salt water solution is infused through the tube and then removed by gentle suctioning from three areas of the lung (lavage). A soft brush is rubbed against the cells lining the lungs and then the tube is removed. The procedure takes about 20 to 30 minutes. 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 18 weeks. They return to the clinic after 2 weeks to repeat the tests done in phase I and to monitor any reactions to the study drug or placebo. If there are no problems, the amount of medication is increased and they return for follow-up evaluations every 2 weeks for 6 weeks, then monthly for 3 months. Pulmonary function tests and bronchoscopy and lavage are repeated after 18 weeks on medication. Phase III Patients return for follow-up 1 month after stopping the medication or placebo to monitor their asthma.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009
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