A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Severe, Refractory Asthma
Completed · Phase 2 · Has a placebo group
Conditions studied: Severe, Refractory Asthma, Airway Inflammation, Airflow Obstruction
In brief
Background: \- 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. Objectives: \- To assess the effectiveness of pioglitazone hydrochloride as a treatment for patients with severe asthma that is not controlled by standard treatments. Eligibility: \- Individuals between 18 and 75 years of age who have been diagnosed with and treated for severe asthma for at least 1 year. Design: * 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.
Key facts
- Study ID
- NCT00994175
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 15
- Starts
- 2009-09-23
- Expected to finish
- 2016-06-24
- Last updated by the study team
- 2017-09-05
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.
- Asthma exacerbation requiring treatment with additional oral corticosteroids in the previous 6 weeks, or a life-threatening asthma attack requiring cardiopulmonary support in the previous 6 months.
- Cigarette smoking within the previous 12 months or a prior history of > 20 cumulative pack-years.
- Investigational therapy for any indication within I month prior to the screening visit.
- History of lung disease other than asthma (ie., COPD, sarcoidosis).
- History of diabetes mellitus requiring treatment with any medication, insulin secreting tumor, or symptomatic hypoglycemia.
- HIV/AIDS
- History of congestive heart failure with current symptoms consistent with NYHA classification II, Ill or IV.
- Preexisting edema (2+ or greater).
- Hemoglobin < 11 gm/dl for males and < 10 gm/dl for females.
- Active liver disease or abnormal liver function tests > 2 times upper limit of normal.
- History of bladder or colon cancer.
- History of other cancer not in remission.
- Active breast feeding.
- Use of the following medications, which can interact with pioglitazone:
- Gemfibrizol (Lopid)
- Atazanivir (Reyataz)
- Ritonavir (Norvir)
- Rifampin (Rifadpin)
- Carbamzepine (Tegretol)
- Phenobarbital (Luminal)
- Phenytoin (Dilantin)
- Rifapentine (Priftin)
- Secobarbital (Seconal)
- Amiodarone (Cordarone, Pacerone)
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
- INOVA Fairfax Hospital — Falls Church, Virginia, United States
Full record on ClinicalTrials.gov
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