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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see whether a new investigational drug (Imatinib) may help improve asthma in people whose symptoms are not well controlled with high dose inhaled corticosteroid treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Baim Institute for Clinical Research; Harvard Clinical Research Institute; National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Imatinib Mesylate

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