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Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease

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ClinicalTrials.gov Identifier: NCT02216357
Recruitment Status : Completed
First Posted : August 13, 2014
Results First Posted : March 22, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Aspirin Exacerbated Respiratory Disease (AERD)
Interventions Drug: Ifetroban, Oral Capsule
Drug: Placebo, Oral Capsule
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
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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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Period Title: Overall Study
Started 14 5
Completed 12 4
Not Completed 2 1
Reason Not Completed
Inclusion or exclusion criteria not met             2             1
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule Total
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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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Total of all reporting groups
Overall Number of Baseline Participants 12 4 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 4 participants 16 participants
46  (11.6) 43  (13.4) 45  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 16 participants
Female
6
  50.0%
2
  50.0%
8
  50.0%
Male
6
  50.0%
2
  50.0%
8
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 16 participants
Hispanic or Latino
2
  16.7%
1
  25.0%
3
  18.8%
Not Hispanic or Latino
10
  83.3%
3
  75.0%
13
  81.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   8.3%
0
   0.0%
1
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  16.7%
0
   0.0%
2
  12.5%
White
9
  75.0%
4
 100.0%
13
  81.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 4 participants 16 participants
12
 100.0%
4
 100.0%
16
 100.0%
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Study Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
Hide Arm/Group Description:

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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Up to Study Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
Hide Arm/Group Description:

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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
2
  16.7%
1
  25.0%
3.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Up to Study Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
Hide Arm/Group Description:

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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Incidence and Severity of Treatment-emergent Adverse Events
Hide Description [Not Specified]
Time Frame Up to Study Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subject reporting at least one adverse event
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
Hide Arm/Group Description:

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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
11
  91.7%
4
 100.0%
5.Secondary Outcome
Title Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge
Hide Description [Not Specified]
Time Frame Study Day 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
Hide Arm/Group Description:

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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge
Hide Description [Not Specified]
Time Frame Study Day 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
Hide Arm/Group Description:

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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
4
  33.3%
1
  25.0%
7.Secondary Outcome
Title Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge
Hide Description [Not Specified]
Time Frame Study Day 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
Hide Arm/Group Description:

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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
  25.0%
1
  25.0%
8.Secondary Outcome
Title Amount of Rescue Medication Required During the Aspirin Challenge
Hide Description The amount of rescue medication required during the aspirin challenge
Time Frame Study Day 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
Hide Arm/Group Description:

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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Overall Number of Participants Analyzed 12 4
Mean (Standard Deviation)
Unit of Measure: number of rescue medications
2.9  (2.02) 7.33  (3.79)
9.Secondary Outcome
Title Incidence and Severity of Asthmatic Reactions During the Treatment Period
Hide Description [Not Specified]
Time Frame Study Day 1 through 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
Hide Arm/Group Description:

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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.
Hide Description [Not Specified]
Time Frame Study Day 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
Hide Arm/Group Description:

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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
30 mg aspirin dose
0
   0.0%
0
   0.0%
60 mg aspirin dose
5
  41.7%
2
  50.0%
100mg aspirin dose
5
  41.7%
1
  25.0%
150 mg aspirin dose
0
   0.0%
0
   0.0%
325 mg aspirin dose
0
   0.0%
0
   0.0%
No Aspirin Reaction
2
  16.7%
1
  25.0%
Time Frame 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ifetroban, Oral Capsule Placebo, Oral Capsule
Hide Arm/Group Description

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; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.

Placebo, Oral Capsule

All-Cause Mortality
Ifetroban, Oral Capsule Placebo, Oral Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Ifetroban, Oral Capsule Placebo, Oral Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ifetroban, Oral Capsule Placebo, Oral Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   11/12 (91.67%)   4/4 (100.00%) 
Eye disorders     
Eye pruritis  1  3/12 (25.00%)  2/4 (50.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/12 (0.00%)  1/4 (25.00%) 
Nausea  1  0/12 (0.00%)  1/4 (25.00%) 
General disorders     
Chest discomfort  1  4/12 (33.33%)  1/4 (25.00%) 
Infections and infestations     
Conjunctivitis  1  2/12 (16.67%)  1/4 (25.00%) 
Investigations     
Forced expiratory volume decreased  1  9/12 (75.00%)  3/4 (75.00%) 
Musculoskeletal and connective tissue disorders     
Joint stiffness  1  0/12 (0.00%)  1/4 (25.00%) 
Muscle spasms  1  0/12 (0.00%)  1/4 (25.00%) 
Nervous system disorders     
Dizziness  1  0/12 (0.00%)  1/4 (25.00%) 
Presyncope  1  0/12 (0.00%)  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders     
Rhinnorrhea  1  9/12 (75.00%)  4/4 (100.00%) 
Sneezing  1  8/12 (66.67%)  3/4 (75.00%) 
Nasal obstruction  1  8/12 (66.67%)  2/4 (50.00%) 
Nasal congestion  1  1/12 (8.33%)  2/4 (50.00%) 
Wheezing  1  2/12 (16.67%)  0/4 (0.00%) 
Throat irritation  1  0/12 (0.00%)  1/4 (25.00%) 
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Senior Manger, Clinical Operations
Organization: Cumberland Pharmaceuticals Inc.
Phone: 615-255-0068 ext 250
EMail: bkaelin@cumberlandpharma.com
Layout table for additonal information
Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02216357    
Other Study ID Numbers: CPI-IFE-003
First Submitted: August 12, 2014
First Posted: August 13, 2014
Results First Submitted: February 2, 2017
Results First Posted: March 22, 2017
Last Update Posted: May 15, 2017