Pioglitazone Hydrochloride (Actos(Registered Trademark)) to Treat Asthma

Withdrawn before enrolling · Phase 2

Conditions studied: Asthma, Airway Inflammation, Airflow Obstruction, Airway Hyperactivity

In brief

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. ...

Key facts

Study ID

NCT00604578

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

0

Starts

2008-01-04

Expected to finish

2009-10-30

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A known history of hypersensitivity to pioglitazone.
• Maintenance asthma therapy with oral corticosteroids, xolair (anti-IgE), methotrexate, cytoxan, gold salts, or cyclosporine.
• Cigarette smoking within the past 3 months or a prior history of greater than 10 cumulative pack-years.
• Viral or bacterial upper respiratory tract infection within 6 weeks prior to the screening visit.
• Investigational therapy for any indication within 1 month prior to the screening visit.
• History of lung disease other than asthma (i.e., COPD, sarcoidosis).
• History of diabetes mellitus, insulin secreting tumor, or symptomatic hypoglycemia.
• HIV or other known immunodeficiency.
• History of congestive heart failure.
• Preexisting edema (2 plus or greater).
• Hemoglobin less than 12 gm/dl for males and less than 11 gm/dl for females.
• History of liver disease or abnormal liver function tests greater than 2 times upper limit of normal.
• History of inflammatory bowel disease.
• History of cancer (other than dermatologic cancer).
• History of drug or alcohol abuse.
• Use of the following medications, which can interact with pioglitazone:
• Gemfibrizol (Lopid)
• Atazanivir (Reyataz)
• Ritonavir (Norvir)
• Rifampin (Rifampicin)
• Carbamzepine (Tegretol)
• Phenobarbital (Luminal)
• Phenytoin (Dilantin)
• Rifapentine (Priftin)
• Secobarbital (Seconal)

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Fairfax Hospital — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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