Trial Outcomes & Findings for Effects of cKit Inhibition by Imatinib in Patients With Severe Refractory Asthma (KIA) (NCT NCT01097694)

Results Overview

Our primary outcome was change in airway hyperresponsiveness, as assessed by PC20, from baseline to 3 and/or 6 months of therapy in imatinib treated participants as compared with controls. Change in PC20 was assessed using log2-transformed ratios of PC20 at month 3 and /or month 6 vs PC20 at baseline. Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed. We used a linear mixed-effects model for a repeated-measures analysis to compare the primary outcome between the two groups. PC20 is determined by the provocation concentration of methacholine causing a 20% fall in forced expiratory volume in one second (FEV1).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

176 participants

Primary outcome timeframe

Over 6 months from beginning of treatment

Results posted on

2017-05-19

Participant Flow

Subjects were recruited from November 2010 until December 2014 in seven academic medical centers.

Following enrollment, 176 subjects entered a run-in period in which several inclusion criteria had to be met prior to randomization, including ACQ requirements and methacholine sensitivity, as well as safety and compliance requirements. 114 subjects who did not meet these inclusion criteria were not randomized.

Participant milestones

Participant milestones
Measure	Imatinib Mesylate Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo Group on Placebo treatment Placebo: Placebo
Overall Study STARTED	32	30
Overall Study COMPLETED	24	26
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Imatinib Mesylate Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo Group on Placebo treatment Placebo: Placebo
Overall Study Adverse Event	5	0
Overall Study Lost to Follow-up	0	3
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imatinib Mesylate n=32 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=30 Participants Group on Placebo treatment Placebo: Placebo	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	30 Participants n=7 Participants	62 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.2 years STANDARD_DEVIATION 10.2 • n=5 Participants	37.7 years STANDARD_DEVIATION 11.8 • n=7 Participants	40.1 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	30 participants n=7 Participants	62 participants n=5 Participants

PRIMARY outcome

Timeframe: Over 6 months from beginning of treatment

Our primary outcome was change in airway hyperresponsiveness, as assessed by PC20, from baseline to 3 and/or 6 months of therapy in imatinib treated participants as compared with controls. Change in PC20 was assessed using log2-transformed ratios of PC20 at month 3 and /or month 6 vs PC20 at baseline. Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed. We used a linear mixed-effects model for a repeated-measures analysis to compare the primary outcome between the two groups. PC20 is determined by the provocation concentration of methacholine causing a 20% fall in forced expiratory volume in one second (FEV1).

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=24 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=26 Participants Group on Placebo treatment Placebo: Placebo
Change in Mean Methacholine Responsiveness as Assessed by the Provocation Concentration Causing a 20% Fall in Forced Expiratory Volume in One Second (FEV1) (PC20) at Month 3 and 6 Versus Baseline	1.73 Log2 Ratio Standard Deviation 0.52	1.07 Log2 Ratio Standard Deviation 0.60

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in serum total tryptase after 24 weeks of imatinib vs placebo treatment

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=19 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=23 Participants Group on Placebo treatment Placebo: Placebo
Serum Total Tryptase	-2.02 ng/ml Standard Deviation 2.32	-0.56 ng/ml Standard Deviation 1.39

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in BAL fluid tryptase levels after 24 weeks of imatinib vs. placebo

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=21 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=26 Participants Group on Placebo treatment Placebo: Placebo
Bronchoalveolar Lavage (BAL) Fluid Tryptase Level	-0.74 ng/mL Standard Deviation 2.35	0.43 ng/mL Standard Deviation 2.19

SECONDARY outcome

Timeframe: 6 months after start of treatment

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=24 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=26 Participants Group on Placebo treatment Placebo: Placebo
Change in Maximum Post-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) %	0.01 % of predicted Standard Deviation 0.2	-0.08 % of predicted Standard Deviation 0.26

SECONDARY outcome

Timeframe: Up to 24 weeks

Number of asthma exacerbations experienced from randomization to study completion.

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=32 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=30 Participants Group on Placebo treatment Placebo: Placebo
Number of Asthma Exacerbations	16 events	20 events

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in FEV1 in treatment group compared to placebo group

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=32 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=30 Participants Group on Placebo treatment Placebo: Placebo
FEV1 in Liters	0.046 L Interval 0.036 to 0.056	0 L Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in FEV1% of predicted

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=24 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=27 Participants Group on Placebo treatment Placebo: Placebo
FEV1%	2.3 % of predicted Standard Deviation 8.86	0.78 % of predicted Standard Deviation 13.1

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in patient-reported morning peak flow measurement (L/s)

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=19 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=20 Participants Group on Placebo treatment Placebo: Placebo
Morning Peak Flow Measurement	7.3 L/second Standard Deviation 46.1	-6.4 L/second Standard Deviation 39.3

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in patient-reported evening peak flow measurement (L/s)

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=19 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=20 Participants Group on Placebo treatment Placebo: Placebo
Evening Peak Flow	8.3 L/second Standard Deviation 53.6	-8.2 L/second Standard Deviation 37.2

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in Fractional Exhaled Nitric Oxide Measurement (ppb)

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=22 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=24 Participants Group on Placebo treatment Placebo: Placebo
Fractional Exhaled Nitric Oxide (FeNO)	7.89 parts per billion Standard Deviation 33.0	-5.92 parts per billion Standard Deviation 33.2

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in patient-reported ACQ score The six-item Asthma Control Questionnaire (ACQ-6) is a scale from 0 to 6 with a lower value denoting an improvement in asthma control. The minimal important difference is 0.5.

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=24 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=27 Participants Group on Placebo treatment Placebo: Placebo
Asthma Control Questionnaire (ACQ)	-0.62 units on a scale Standard Deviation 0.96	-0.49 units on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in patient-reported Asthma Quality of Life Questionnaire (AQLQ) score The asthma quality of life questionnaire (AQLQ) is a 32-item scale with a range from 1-7 with a higher value denoting improvement. The minimal important difference is 0.5.

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=20 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=24 Participants Group on Placebo treatment Placebo: Placebo
Asthma Quality of Life Questionnaire (AQLQ)	0.55 units on a scale Standard Deviation 1.0	0.25 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in patient reported ASUI score The asthma symptom utility index (ASUI) is a 10-item weighted scale with a range from 0.2 to 1 with a higher value indicating improvement. The minimal important difference is 0.09.

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=20 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=24 Participants Group on Placebo treatment Placebo: Placebo
Asthma Symptom Utility Index (ASUI)	0.07 units on a scale Standard Deviation 0.20	0.05 units on a scale Standard Deviation 0.18

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in BAL neutrophil percentage from baseline

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=17 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=20 Participants Group on Placebo treatment Placebo: Placebo
BAL Neutrophil %	-0.8 % neutrophils Standard Deviation 5.6	-0.4 % neutrophils Standard Deviation 7.0

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in BAL eosinophil percentage

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=17 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=26 Participants Group on Placebo treatment Placebo: Placebo
BAL Eosinophil %	2.55 % eosinophils Standard Deviation 8.8	-2.63 % eosinophils Standard Deviation 10.4

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in bronchoalveolar lavage (BAL) PGD2 levels from baseline at 6 months

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=21 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=26 Participants Group on Placebo treatment Placebo: Placebo
Bronchoalveolar Lavage (BAL) PGD2	12.2 pg/mL Standard Deviation 57.2	-4.2 pg/mL Standard Deviation 54.4

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in endobronchial biopsy total tryptase-positive mast cells from baseline at 6 months

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=23 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=26 Participants Group on Placebo treatment Placebo: Placebo
Endobronchial Biopsy Total Tryptase-positive Mast Cells	-54.2 mast cells per mm2 Standard Deviation 96.5	-32.3 mast cells per mm2 Standard Deviation 79.8

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in the biopsy smooth muscle tryptase-positive mast cells from baseline at 6 months

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=23 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=26 Participants Group on Placebo treatment Placebo: Placebo
Endobronchial Biopsy Smooth Muscle Tryptase-positive Mast Cells	-102.7 mast cells per mm2 Standard Deviation 167.9	-79.2 mast cells per mm2 Standard Deviation 157.3

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in blood eosinophil count

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=20 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=20 Participants Group on Placebo treatment Placebo: Placebo
Blood Eosinophils	-10.2 eosinophils per microliter Standard Deviation 50.6	-2.6 eosinophils per microliter Standard Deviation 25.6

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in airway wall thickness as assessed by computerized tomography (CT)

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=21 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=27 Participants Group on Placebo treatment Placebo: Placebo
Airway Wall Thickness	-0.0040 % of airway Standard Deviation 0.03	-0.0027 % of airway Standard Deviation 0.02

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in airway wall area as assessed by computerized tomography (CT)

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=21 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=27 Participants Group on Placebo treatment Placebo: Placebo
Airway Wall Area	0.0002 % of area Standard Deviation 0.02	0.0002 % of area Standard Deviation 0.02

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in bronchoalveolar lavage histamine levels from baseline

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=21 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=26 Participants Group on Placebo treatment Placebo: Placebo
Bronchoalveolar Lavage Histamine	2.1 nM Standard Deviation 6.3	-1.1 nM Standard Deviation 13.4

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in urinary Prostaglandin D2 levels from baseline

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=20 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=20 Participants Group on Placebo treatment Placebo: Placebo
Urinary Prostaglandin D2	-0.30 ng/mg Creatinine Standard Deviation 1.5	0.39 ng/mg Creatinine Standard Deviation 1.73

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in bronchoalveolar lavage cysteinyl leukotrienes levels from baseline

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=21 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=26 Participants Group on Placebo treatment Placebo: Placebo
Bronchoalveolar Lavage Cysteinyl Leukotrienes	3.0 pg/mL Standard Deviation 37.3	6.5 pg/mL Standard Deviation 32.9

SECONDARY outcome

Timeframe: 6 months after start of treatment

Change in urinary leukotriene E4 levels from baseline

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=17 Participants Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=13 Participants Group on Placebo treatment Placebo: Placebo
Urinary Leukotriene E4	0.07 ng/mg Creatinine Standard Deviation 0.65	0.01 ng/mg Creatinine Standard Deviation 0.18

SECONDARY outcome

Timeframe: baseline to 24 weeks

Population: Sputum sample slide preparation quality was poor and samples meeting quality control were insufficient for analysis of sputum differential. Insufficient study funds prevented assessment of sputum tryptase. IL-13 was below the detection limit of assay in sputum supernatant.

Change in sputum eosinophil and neutrophil percentage. Change in sputum supernatant tryptase as measured by ELISA. Change in sputum IL-13 level as measured by ELISA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to week 24

Population: The exhaled breath condensate was not processed for inflammatory mediators.

Assessment of change in eicosanoids in the exhaled breath condensate

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to week 24

Population: Self-reported asthma symptom free days were not entered into the study database.

Outcome measures

Outcome data not reported

Adverse Events

Imatinib Mesylate

Serious events: 3 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Imatinib Mesylate n=32 participants at risk Group on active imatinib treatment Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.	Placebo n=30 participants at risk Group on Placebo treatment Placebo: Placebo
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation	6.2% 2/32 • Number of events 2 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.	10.0% 3/30 • Number of events 6 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.
Gastrointestinal disorders Nausea	3.1% 1/32 • Number of events 1 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.	0.00% 0/30 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.
Blood and lymphatic system disorders Leukocytosis	3.1% 1/32 • Number of events 1 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.	0.00% 0/30 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.
Musculoskeletal and connective tissue disorders Leg Cramps	3.1% 1/32 • Number of events 1 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.	0.00% 0/30 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.
Metabolism and nutrition disorders Hypokalemia	3.1% 1/32 • Number of events 1 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.	0.00% 0/30 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.
Infections and infestations Acute URI	0.00% 0/32 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.	3.3% 1/30 • Number of events 1 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.
Musculoskeletal and connective tissue disorders Ankle Dislocation	0.00% 0/32 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.	3.3% 1/30 • Number of events 1 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.
Immune system disorders Angioedemia	0.00% 0/32 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.	3.3% 1/30 • Number of events 1 • Adverse event data were collected from randomization to study drug vs. placebo up to 24 weeks.

Other adverse events

Additional Information

Elliot Israel, MD

Brigham and Women's Hopsital

Phone: 617-732-8110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place