Effects of cKit Inhibition by Imatinib in Patients With Severe Refractory Asthma (KIA)

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Mar 31, 2010

Keywords

ClinConnect Summary

Severe asthmatics remain poorly controlled despite high doses of standard asthma therapy or even daily doses of systemic corticosteroids or their equivalent. They account for a large proportion of the morbidity and mortality associated with asthma. Features that seem to characterize many patients with this disorder include persistent inflammation, symptoms, and airway hyperresponsiveness in the face of corticosteroid therapy. Mast cells are powerful, long-lived tissue dwelling effector cells that are resistant to corticosteroid effects and have been implicated in the pathobiology of asthma....

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients 18-65 years of age, diagnosed with asthma for at least 1 year;
• • 2. Refractory asthma, defined as reporting that their asthma has not been completely controlled in the past 3 months despite continuous treatment with high-dose inhaled corticosteroids (ICS) and an additional controller medication, with or without continuous oral corticosteroids (OCS)
• Exclusion Criteria:
• • 1. Current smoking or smoking history of greater than 10 pack-years
• • 2. Any other significant respiratory or cardiac disease, or the presence of clinically important comorbidities, including uncontrolled diabetes, uncontrolled coronary artery disease
• • 3. If subject cannot undergo bronchoscopy procedure due to safety reasons
• • 4. Previous treatment with Imatinib
• • 5. A history of acute heart failure or chronic left sided heart failure
• • 6. Uncontrolled systemic arterial hypertension
• • 7. History of major bleeding or intracranial hemorrhage
• • 8. History of immunodeficiency diseases, including HIV
• • 9. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
• • 10. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• • 11. Diagnosis of Hepatitis B or C.
• • 12. History of alcohol abuse within 6 months of screening.
• • 13. History of illicit drug abuse within 6 months of screening.
• • 14. Regular use of anticoagulants (eg: Warfarin Sodium, Coumadin), amiodarone, carbamazepine, Cyclosporine, Rifampicin, or reverse transcriptase inhibitors