MedTrace Logo

Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)

NCT03028350 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-07-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Asthma, Aspirin-Induced

Interventions

DRUG

Ifetroban Oral Capsule

Subjects will be treated with oral ifetroban daily for 8 weeks

DRUG

Placebo Oral Capsule

Subjects will be treated with oral placebo daily for 8 weeks

Sponsors & Collaborators

  • Cumberland Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Andrew White, MD · Scripps Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2023-04-25
Completion
2023-04-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03028350 on ClinicalTrials.gov