Trial Outcomes & Findings for Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD) (NCT NCT03028350)
NCT ID: NCT03028350
Last Updated: 2024-07-10
Results Overview
Sinonasal Outcome Test-22 (SNOT-22) score is a scale with a minimum score of 0 and a maximum score of 110 based on the presence and severity of symptoms and outcomes of rhinosinusitis. Higher scores indicate worse symptoms and/or outcomes.
COMPLETED
PHASE2
54 participants
Baseline and 8 weeks
2024-07-10
Participant Flow
Participant milestones
| Measure |
Ifetroban Oral Capsule
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
29
|
|
Overall Study
COMPLETED
|
21
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
Baseline characteristics by cohort
| Measure |
Ifetroban Oral Capsule
n=25 Participants
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
n=29 Participants
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=99 Participants
|
45 years
n=107 Participants
|
51 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
29 participants
n=107 Participants
|
54 participants
n=206 Participants
|
|
Weight
|
84.2 kg
n=99 Participants
|
85.4 kg
n=107 Participants
|
84.4 kg
n=206 Participants
|
|
BMI (kg/m2), Categorical >=30; <30
>=30
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
BMI (kg/m2), Categorical >=30; <30
<30
|
14 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
BMI (kg/m2), Continuous
|
28.8 kg/m^2
n=99 Participants
|
27.0 kg/m^2
n=107 Participants
|
27.8 kg/m^2
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: All subjects enrolled with SNOT-22 measurements at both baseline and 8 weeks were included. Three enrolled subjects treated with ifetroban did not have SNOT-22 measurements for both timepoints and therefore were not analyzed for this outcome.
Sinonasal Outcome Test-22 (SNOT-22) score is a scale with a minimum score of 0 and a maximum score of 110 based on the presence and severity of symptoms and outcomes of rhinosinusitis. Higher scores indicate worse symptoms and/or outcomes.
Outcome measures
| Measure |
Ifetroban Oral Capsule
n=22 Participants
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
n=29 Participants
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
|---|---|---|
|
Change From Baseline in Sinonasal Outcome Test-22 Score
|
-6.7 units on a scale
Standard Deviation 12.9
|
-13.7 units on a scale
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: All subjects enrolled with Asthma Control Questionnaire-7 measurements at both baseline and 8 weeks were included. Ten enrolled subjects treated with ifetroban and 5 enrolled subjects treated with placebo did not have Asthma Control Questionnaire-7 measurements for both timepoints and therefore were not analyzed for this outcome.
The Asthma Control Questionnaire-7 is a scoring system with a minimum score of 0 and a maximum score of 6 based on the severity and frequency of asthma symptoms. Higher scores indicate worse control of asthma symptoms.
Outcome measures
| Measure |
Ifetroban Oral Capsule
n=15 Participants
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
n=24 Participants
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire -7 Score
|
0.30 units on a scale
Standard Deviation 1.44
|
-0.20 units on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: All subjects enrolled with Total Nasal Symptom Score (morning) measurements at both baseline and 8 weeks were included. Five enrolled subjects treated with ifetroban and 9 enrolled subjects treated with placebo did not have Total Nasal Symptom Score (morning) measurements for both timepoints and therefore were not analyzed for this outcome.
The Total Nasal Symptom Score is a scoring system with a minimum score of 0 and maximum score of 15 based on severity of nasal symptoms. Higher scores indicate worse nasal symptoms.
Outcome measures
| Measure |
Ifetroban Oral Capsule
n=20 Participants
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
n=20 Participants
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
|---|---|---|
|
Change From Baseline in Total Nasal Symptom Score (Morning)
|
-1.28 units on a scale
Standard Deviation 1.85
|
-2.57 units on a scale
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: All subjects enrolled with FEV1 measurements at both baseline and 8 weeks were included. Four enrolled subjects treated with ifetroban and 1 enrolled subject treated with placebo did not have FEV1 measurements at both times and therefore were not analyzed for this outcome.
Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Outcome measures
| Measure |
Ifetroban Oral Capsule
n=21 Participants
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
n=28 Participants
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
|
0.010 liters
Standard Deviation 0.421
|
0.004 liters
Standard Deviation 0.323
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: All subjects enrolled with PNIFR measurements at both baseline and 8 weeks were included. Five enrolled subjects treated with ifetroban and 1 enrolled subject treated with placebo did not have PNIFR measurements for both timepoints and therefore were not analyzed for this outcome.
Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR) at 8 weeks
Outcome measures
| Measure |
Ifetroban Oral Capsule
n=20 Participants
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
n=28 Participants
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
|---|---|---|
|
Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR)
|
11.4 liters/minute
Standard Deviation 48.3
|
-3.70 liters/minute
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: All subjects enrolled with FeNO measurements at both baseline and 8 weeks were included. Six enrolled subjects treated with ifetroban and 2 enrolled subjects treated with placebo did not have FeNO measurements for both timepoints and therefore were not analyzed for this outcome.
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at 8 weeks
Outcome measures
| Measure |
Ifetroban Oral Capsule
n=19 Participants
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
n=27 Participants
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
|---|---|---|
|
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
|
5.70 parts per billion
Standard Deviation 9.32
|
1.40 parts per billion
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: All subjects enrolled with Total Nasal Symptom Score (afternoon/evening) measurements at both baseline and 8 weeks were included. Eleven enrolled subjects treated with ifetroban and 6 enrolled subjects treated with placebo did not have Total Nasal Symptom Score (afternoon/evening) measurements for both timepoints and therefore were not analyzed for this outcome.
The Total Nasal Symptom Score is a scale with a minimum score of 0 and maximum score of 15 based on severity of nasal symptoms. Higher scores indicate worse nasal symptoms.
Outcome measures
| Measure |
Ifetroban Oral Capsule
n=14 Participants
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
n=23 Participants
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
|---|---|---|
|
Change From Baseline in Total Nasal Symptom Score (Afternoon/Evening)
|
-0.519 units on a scale
Standard Deviation 2.28
|
-1.58 units on a scale
Standard Deviation 2.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeksPopulation: All subjects enrolled with blood eosinophil measurements at both baseline and 8 weeks were included. Eleven enrolled subjects treated with ifetroban and 13 enrolled subjects treated with placebo did not have blood eosinophil measurements for both timepoints and therefore were not analyzed for this outcome.
Change From Baseline in Blood Eosinophil Count at 8 Weeks
Outcome measures
| Measure |
Ifetroban Oral Capsule
n=14 Participants
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
n=16 Participants
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
|---|---|---|
|
Change From Baseline in Blood Eosinophil Count
|
0.00 x10^9 cells/liter
Standard Deviation 0.22
|
-0.09 x10^9 cells/liter
Standard Deviation 0.26
|
Adverse Events
Ifetroban Oral Capsule
Placebo Oral Capsule
Serious adverse events
| Measure |
Ifetroban Oral Capsule
n=25 participants at risk
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
n=29 participants at risk
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
|---|---|---|
|
Infections and infestations
Diverticulitis
|
4.0%
1/25 • Number of events 1 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
0.00%
0/29 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
Other adverse events
| Measure |
Ifetroban Oral Capsule
n=25 participants at risk
Oral ifetroban, 200 mg daily for 8 weeks
Ifetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks
|
Placebo Oral Capsule
n=29 participants at risk
Oral placebo daily for 8 weeks
Placebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
6.9%
2/29 • Number of events 2 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
|
Infections and infestations
Sinusitis
|
16.0%
4/25 • Number of events 5 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
10.3%
3/29 • Number of events 3 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.0%
2/25 • Number of events 6 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
0.00%
0/29 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 3 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
10.3%
3/29 • Number of events 3 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/25 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
6.9%
2/29 • Number of events 3 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/25 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
10.3%
3/29 • Number of events 6 • Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)
The severity of each event is reported by the investigator according to the following definitions: * Mild: Transient symptoms, no interference with the subject's daily activities. * Moderate: Marked symptoms, moderate interference with the subject's daily activities. * Severe: Considerable interference with the subject's daily activities, unacceptable.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60