Phase 2
N=36
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban
Nasal Polyps · Asthma, Aspirin-Induced · Aspirin-exacerbated Respiratory Disease · Aspirin-Sensitive Asthma With Nasal Polyps
Bottom Line
View on ClinicalTrials.gov: NCT03326063 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Provocative Dose 2 (PD2) During Aspirin Challenge — 121; 142 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ifetroban (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Provocative Dose 2 (PD2) During Aspirin Challenge |
121; 142 | — |
| SECONDARY Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction) |
-18.8; -8.4 | — |
| SECONDARY Aspirin-induced Leukotriene E4 (LTE4) Levels |
0.72; 0.15 | — |
| SECONDARY Change in Chronic Disease Control by Measurement of Lung Function Through FEV1 |
-0.2; -0.5 | — |
| SECONDARY Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score |
0.17; -0.03 | — |
| SECONDARY Clinical Improvement of Chronic Disease - Sino-Nasal Outcome Test (SNOT-22) Score |
1.5; -2.0 | — |
| SECONDARY Fractional Exhaled Nitric Oxide (FeNO) |
7.9; -3.4 | — |
Summary
The overall aim of the study is to determine the efficacy of oral ifetroban, a novel antagonist of T prostanoid (TP) receptors, as a treatment for patients with aspirin-exacerbated respiratory disease (AERD).
Eligibility Criteria
Inclusion Criteria
- History of AERD, defined as meeting the diagnostic triad with:
- History of physician-diagnosed asthma and
- History of physician-diagnosed nasal polyposis and
- History of pathognomonic reactions aspirin or other nonselective cyclooxygenase (COX) inhibitors.
- Stable asthma (post-bronchodilator forced expiratory volume at one second (FEV1) of ≥70%, no glucocorticoid burst for at least 2 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 6 months)
- Age between 18 and 70 years
- No current smoking (not more than one instance of smoking in the last 3 months)
- Non-pregnant
Exclusion Criteria
- Hypersensitivity to montelukast
- Current use of zileuton
- History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
- Current use of any NSAIDs aside from the aspirin provided during the study
- Current use of beta blockers
- Use of any biologics within the last 4 months prior to initiating the study
Data sourced from ClinicalTrials.gov (NCT03326063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.