Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban

NCT03326063 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2017P001523
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Provocative Dose 2 (PD2) During Aspirin Challenge

  The calculated dose of aspirin that induces an increase in the Total Nasal Symptom Score (TNSS) of 2 from the pre-aspirin challenge value, "PD2" TNSS: A higher TNSS score suggests more severe symptoms, on a scale from 0-65 PD2: A higher PD2 suggests that the patient's threshold of reactivity of aspirin was higher

  6 weeks from screening visit ( at visit 2)

Secondary Outcomes (6)

• Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction)

  At Visit 2. The change in FEV1 from the morning baseline to the aspirin-induced lowest value in FEV1 during reaction to aspirin challenge later that same day.

• Aspirin-induced Leukotriene E4 (LTE4) Levels

  Visit 2. The change in LTE4 levels from the morning baseline to the aspirin-induced highest value in LTE4 during reaction to aspirin challenge that same day.

• Change in Chronic Disease Control by Measurement of Lung Function Through FEV1

  1 month (between Visit 1 and Visit 2)

• Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score

  1 month (between Visit 1 and Visit 2)

• Clinical Improvement of Chronic Disease - Sino-Nasal Outcome Test (SNOT-22) Score

  1 month (between Visit 1 and Visit 2)

Other Outcomes (8)

• Percent Change in Urinary Eicosanoid (TXB2 and LTE4) Levels

  1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2)

• Nasal Eicosanoid Changes

  1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2)

• Plasma/Serum Tryptase Changes

  1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2)

Study Arms (2)

Ifetroban

ACTIVE COMPARATOR

Subjects will be randomized to receive ifetroban (200 mg dose per day) for 4 weeks.

Drug: Ifetroban

Placebo

PLACEBO COMPARATOR

Subjects will be randomized to receive placebo for 4 weeks.

Drug: Placebo

Interventions

Ifetroban DRUG

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

Also known as: ifetroban sodium

Ifetroban

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Asthma Research Center, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Nasal Polyps; Asthma, Aspirin-Induced

Interventions

ifetroban

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Asthma; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Results Point of Contact

• Title: Tanya Laidlaw, MD
• Organization: Brigham and Women's Hospital

tlaidlaw@bwh.harvard.edu

617-525-1034

Study Officials

• Elliot Israel, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Asthma Research Center

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: October 30, 2017
• Study Start: April 26, 2018
• Primary Completion: March 30, 2022
• Study Completion: April 15, 2023
• Last Updated: July 14, 2023
• Results First Posted: July 14, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)