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Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban

NCT03326063 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-07-14

Study results available
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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).

Conditions

  • Nasal Polyps
  • Asthma, Aspirin-Induced
  • Aspirin-exacerbated Respiratory Disease
  • Aspirin-Sensitive Asthma With Nasal Polyps

Interventions

DRUG

Ifetroban

4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD

DRUG

Placebo

4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Elliot Israel, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2022-03-30
Completion
2023-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03326063 on ClinicalTrials.gov