A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Severe, Refractory Asthma - NCT00994175-22042(Clinical Trial 368822)
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| City: |
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Falls Church |
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State:
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VA |
| Zip Code: |
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22042 |
| Conditions: |
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Severe, Refractory Asthma - Airway Inflammation - Airflow Obstruction |
| Purpose: |
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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(Registered Trademark)), which is used to treat patients with diabetes, may be
effective for treating severe asthma. Researchers are interested in determining whether
Actos(Registered Trademark) 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.
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| Study summary: |
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New therapies are needed for patients with asthma who are sub-optimally controlled by
standard measures. Pioglitazone hydrochloride (Actos(Registered Trademark)) is a highly
selective and potent agonist for the peroxisome proliferator-activated receptor-Gamma (PPAR
Gamma). Studies in murine models of allergic asthma have shown that PPAR Gamma agonists
down-regulate allergen-mediated airway inflammation and airway hyperresponsiveness. This
protocol is a randomized, placebo-controlled, doubleblind, crossover (phase II) pilot study
of the efficacy of pioglitazone for the treatment of patients with severe, refractory
asthma. The primary end-point for this study will be quality of life as determined by the
Asthma Quality of Life Questionnaire (AQLQ) score. Secondary end-points will include indices
of airway inflammation, airflow obstruction, airway hyperreactivity, and asthma symptoms. |
| Criteria: |
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- 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.
- 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 > 10
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(Registered Trademark))
- 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. |
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| Study is available at: |
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INOVA Fairfax Hospital
Falls Church, VA 22042
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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