Airway Inflammation Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Severe, Refractory Asthma
Verified date | February 23, 2017 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | June 24, 2016 |
Est. primary completion date | June 24, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
United States | INOVA Fairfax Hospital | Falls Church | Virginia |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Berry MA, Hargadon B, Shelley M, Parker D, Shaw DE, Green RH, Bradding P, Brightling CE, Wardlaw AJ, Pavord ID. Evidence of a role of tumor necrosis factor alpha in refractory asthma. N Engl J Med. 2006 Feb 16;354(7):697-708. — View Citation
Erin EM, Leaker BR, Nicholson GC, Tan AJ, Green LM, Neighbour H, Zacharasiewicz AS, Turner J, Barnathan ES, Kon OM, Barnes PJ, Hansel TT. The effects of a monoclonal antibody directed against tumor necrosis factor-alpha in asthma. Am J Respir Crit Care Med. 2006 Oct 1;174(7):753-62. Retraction in: Am J Respir Crit Care Med. 2011 Feb 1;183(3):418. — View Citation
Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of life as determined by the validated Asthma Quality of Life Questionnaire (AQLQ) | 3 years | ||
Secondary | Airway inflammation, airflow obstruction, asthma symptoms, asthma exacerbations, blood eosinophil counts, serum IgE and exhaled nitric oxide levels | 3 years |
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