A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Severe, Refractory Asthma

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.