CompletedPhase 2

Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban

United States38 participantsStarted 2018-04-26

Plain-language 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).

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. History of AERD, defined as meeting the diagnostic triad with:
✓. 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

What they're measuring

Provocative Dose 2 (PD2) During Aspirin Challenge

Timeframe: 6 weeks from screening visit ( at visit 2)

Trial details

NCT IDNCT03326063

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-30

Results submitted2023-05-22

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