Status:
COMPLETED
A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Severe, Refractory Asthma
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Severe, Refractory Asthma
Airway Inflammation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
New therapies are needed for patients with asthma who are sub-optimally controlled by standard measures. Pioglitazone hydrochloride (Actos ) is a highly selective and potent agonist for the peroxisome...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects will be between 18 and 75 years of age, male or female, with a diagnosis of severe, refractory asthma, as defined by the American Thoracic Society, for at least one year.
- Subjects must have a history of reversible airflow obstruction as defined by a positive methacholine bronchoprovocation challenge or a positive response to inhaled bronchodilators at some point in the course of their disease or a greater than 20% variability in the Forced Expiratory Volume in 1 second (FEV1) or the peak expiratory flow (PEF) documented during serial measurements of lung function over time.
- Left ventricular ejection fraction greater than or equal to 50% by echocardiogram
- For women of childbearing potential, negative pregnancy test prior to study and willingness to adhere to reliable birth control methods during the study.
- Subjects must have the ability to provide informed consent
- EXCLUSION CRITERIA:
- 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)
- Palitaxel (Taxol)
- Replaglinide (Prandine)
- Ketoconazole (Nizoral)
- Atorvastatin (Lipitor )
- Fosphenytoin (Cerebyx)
- Itraconazole (Sporanox)
- Trimethoprim (in Bactrim)
- Thioridazine
- Certain over-the-counter herbs and supplements. These will be reviewed by the investigators for possible interactions with the study medication A determination of whether the supplement is safe to use with pioglitazone will be made on a case-by-case basis.
- Any condition that, in the investigator s opinion, places the patient at undue risk for complications from pioglitazone therapy.
Exclusion
Key Trial Info
Start Date :
September 23 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00994175
Start Date
September 23 2009
End Date
June 24 2016
Last Update
September 5 2017
Active Locations (2)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
2
INOVA Fairfax Hospital
Falls Church, Virginia, United States, 22042