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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01097694

Run by

Brigham and Women's Hospital

People needed

176

Starts

2010-11-01

Expected to finish

2016-08-01

Last updated by the study team

2017-05-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18-65 years of age, diagnosed with asthma for at least 1 year;
• 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)

You may not qualify if…

• Current smoking or smoking history of greater than 10 pack-years
• Any other significant respiratory or cardiac disease, or the presence of clinically important comorbidities, including uncontrolled diabetes, uncontrolled coronary artery disease
• If subject cannot undergo bronchoscopy procedure due to safety reasons
• Previous treatment with Imatinib
• A history of acute heart failure or chronic left sided heart failure
• Uncontrolled systemic arterial hypertension
• History of major bleeding or intracranial hemorrhage
• History of immunodeficiency diseases, including HIV
• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
• 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.
• Diagnosis of Hepatitis B or C.
• History of alcohol abuse within 6 months of screening.
• History of illicit drug abuse within 6 months of screening.
• Regular use of anticoagulants (eg: Warfarin Sodium, Coumadin), amiodarone, carbamazepine, Cyclosporine, Rifampicin, or reverse transcriptase inhibitors

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Brigham and Womens Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Temple University — Philadelphia, Pennsylvania, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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