CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Ifetroban Oral Capsule +1 moredrug
Likely dose
Oral ifetroban daily for 8 weeks (specific dose not stated)AI-extracted
Key inclusion· 5
  • ✓Physician-diagnosed asthma with stable disease (post-bronchodilator FEV1 ≥60%, no glucocorticoid burst ≥2 weeks, no exacerbations ≥3 months, ≤1000 µg fluticasone equivalent daily)
  • ✓History of nasal polyposis
  • ✓At least two documented reactions to aspirin or NSAIDs with lower airway involvement (cough, chest tightness, wheezing, dyspnea); or one life-threatening reaction requiring hospitalization; or physician-confirmed aspirin challenge in past 5 years
  • ✓Symptomatic AERD confirmed by SNOT-22 score ≥20 within 3 weeks of starting treatment
Key exclusion· 10
  • ✕Current smoking (daily tobacco use in past 6 months AND ≥1 instance in past 3 months)
  • ✕Pregnancy or breastfeeding
  • ✕Oral/systemic steroids >20 mg daily (prednisone or equivalent) in past 4 weeks
  • ✕Daily long-acting antihistamine use in past 2 weeks

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03028350
NCT03028350Phase 2Completed
CompareCT.gov

A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)

Cumberland Pharmaceuticals·interventional·Posted Jan 23, 2017·Updated Jul 10, 2024

In Brief

A Phase 2 clinical trial evaluating Ifetroban Oral Capsule and Placebo Oral Capsule for Asthma, Aspirin-Induced. Completed, enrolled 54 participants across 16 sites.

Detailed Summary

The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Aspirin-Induced
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 23, 2017
Enrollment StartJul 17, 2017
Primary CompletionApr 25, 2023
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 9.4 years ago

Interventions

Ifetroban Oral Capsuledrug

Subjects will be treated with oral ifetroban daily for 8 weeks

Placebo Oral Capsuledrug

Subjects will be treated with oral placebo daily for 8 weeks