Trial Outcomes & Findings for Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease (NCT NCT02216357)
NCT ID: NCT02216357
Last Updated: 2017-05-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Study Day 2
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
Ifetroban, Oral Capsule
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
Placebo, Oral Capsule
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
5
|
|
Overall Study
COMPLETED
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Ifetroban, Oral Capsule
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
Placebo, Oral Capsule
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
|---|---|---|
|
Overall Study
Inclusion or exclusion criteria not met
|
2
|
1
|
Baseline Characteristics
Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease
Baseline characteristics by cohort
| Measure |
Ifetroban, Oral Capsule
n=12 Participants
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
Placebo, Oral Capsule
n=4 Participants
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 11.6 • n=93 Participants
|
43 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
45 years
STANDARD_DEVIATION 11.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Study Day 2Outcome measures
| Measure |
Placebo, Oral Capsule
n=4 Participants
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
Ifetroban, Oral Capsule
n=12 Participants
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
|---|---|---|
|
Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Study Day 2Outcome measures
| Measure |
Placebo, Oral Capsule
n=4 Participants
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
Ifetroban, Oral Capsule
n=12 Participants
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
|---|---|---|
|
Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Study Day 2Outcome measures
| Measure |
Placebo, Oral Capsule
n=4 Participants
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
Ifetroban, Oral Capsule
n=12 Participants
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
|---|---|---|
|
Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Study Day 7Population: Number of subject reporting at least one adverse event
Outcome measures
| Measure |
Placebo, Oral Capsule
n=4 Participants
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
Ifetroban, Oral Capsule
n=12 Participants
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
|---|---|---|
|
Incidence and Severity of Treatment-emergent Adverse Events
|
4 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Study Day 2 and 3Outcome measures
| Measure |
Placebo, Oral Capsule
n=4 Participants
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
Ifetroban, Oral Capsule
n=12 Participants
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
|---|---|---|
|
Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Study Day 2 and 3Outcome measures
| Measure |
Placebo, Oral Capsule
n=4 Participants
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
Ifetroban, Oral Capsule
n=12 Participants
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
|---|---|---|
|
Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Study Day 2 and 3Outcome measures
| Measure |
Placebo, Oral Capsule
n=4 Participants
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
Ifetroban, Oral Capsule
n=12 Participants
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
|---|---|---|
|
Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Study Day 2 and 3The amount of rescue medication required during the aspirin challenge
Outcome measures
| Measure |
Placebo, Oral Capsule
n=4 Participants
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
Ifetroban, Oral Capsule
n=12 Participants
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
|---|---|---|
|
Amount of Rescue Medication Required During the Aspirin Challenge
|
7.33 number of rescue medications
Standard Deviation 3.79
|
2.9 number of rescue medications
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: Study Day 1 through 3Outcome measures
| Measure |
Placebo, Oral Capsule
n=4 Participants
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
Ifetroban, Oral Capsule
n=12 Participants
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
|---|---|---|
|
Incidence and Severity of Asthmatic Reactions During the Treatment Period
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Study Day 2 and 3Outcome measures
| Measure |
Placebo, Oral Capsule
n=4 Participants
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
Ifetroban, Oral Capsule
n=12 Participants
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
|---|---|---|
|
Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.
30 mg aspirin dose
|
0 Participants
|
0 Participants
|
|
Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.
No Aspirin Reaction
|
1 Participants
|
2 Participants
|
|
Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.
60 mg aspirin dose
|
2 Participants
|
5 Participants
|
|
Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.
100mg aspirin dose
|
1 Participants
|
5 Participants
|
|
Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.
150 mg aspirin dose
|
0 Participants
|
0 Participants
|
|
Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.
325 mg aspirin dose
|
0 Participants
|
0 Participants
|
Adverse Events
Ifetroban, Oral Capsule
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo, Oral Capsule
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ifetroban, Oral Capsule
n=12 participants at risk
Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Ifetroban, Oral Capsule
|
Placebo, Oral Capsule
n=4 participants at risk
Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Placebo, Oral Capsule
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinnorrhea
|
75.0%
9/12 • 7 days
|
100.0%
4/4 • 7 days
|
|
Investigations
Forced expiratory volume decreased
|
75.0%
9/12 • 7 days
|
75.0%
3/4 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
66.7%
8/12 • 7 days
|
75.0%
3/4 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
66.7%
8/12 • 7 days
|
50.0%
2/4 • 7 days
|
|
General disorders
Chest discomfort
|
33.3%
4/12 • 7 days
|
25.0%
1/4 • 7 days
|
|
Eye disorders
Eye pruritis
|
25.0%
3/12 • 7 days
|
50.0%
2/4 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • 7 days
|
50.0%
2/4 • 7 days
|
|
Infections and infestations
Conjunctivitis
|
16.7%
2/12 • 7 days
|
25.0%
1/4 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
2/12 • 7 days
|
0.00%
0/4 • 7 days
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/12 • 7 days
|
25.0%
1/4 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/12 • 7 days
|
25.0%
1/4 • 7 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • 7 days
|
25.0%
1/4 • 7 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • 7 days
|
25.0%
1/4 • 7 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • 7 days
|
25.0%
1/4 • 7 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • 7 days
|
25.0%
1/4 • 7 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • 7 days
|
25.0%
1/4 • 7 days
|
Additional Information
Senior Manger, Clinical Operations
Cumberland Pharmaceuticals Inc.
Phone: 615-255-0068
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place