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TP Receptor Antagonist

Ifetroban for Respiratory Disease

Phase 2
Waitlist Available
Led By Elliot Israel, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month (between visit 1 and visit 2) and 6 weeks from screening visit ( at visit 2)
Awards & highlights

Study Summary

This trial will test if a new drug, ifetroban, can help people with a specific kind of respiratory disease that gets worse with aspirin.

Eligible Conditions
  • Aspirin Exacerbated Respiratory Disease
  • Asthma
  • Nasal Polyps

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month (between visit 1 and visit 2) and 6 weeks from screening visit ( at visit 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month (between visit 1 and visit 2) and 6 weeks from screening visit ( at visit 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Provocative Dose 2 (PD2) During Aspirin Challenge
Secondary outcome measures
Aspirin-induced Leukotriene E4 (LTE4) Levels
Change in Chronic Disease Control by Measurement of Lung Function Through FEV1
Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score
+3 more
Other outcome measures
Nasal Eicosanoid Changes
Nasal Tryptase Changes
Percent Change in Urinary Eicosanoid (TXB2 and LTE4) Levels
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: IfetrobanActive Control1 Intervention
Subjects will be randomized to receive ifetroban (200 mg dose per day) for 4 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be randomized to receive placebo for 4 weeks.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,614 Previous Clinical Trials
11,470,797 Total Patients Enrolled
Elliot Israel, MDPrincipal Investigator - Brigham and Women's Hospital
Brigham & Women's Hospital, Brigham and Women's Physicians Organization
Johns Hopkins University School Of Medicine (Medical School)
Ny & Presby Hp-Cornell Campus (Residency)
14 Previous Clinical Trials
5,051 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are you looking for more people to enroll in this research?

"The clinical trial mentioned is not currently looking for patients, as indicated by the data on clinicaltrials.gov. The trial was first posted on April 26th, 2018 and updated for the last time on October 7th, 2020. There are other 483 trials that are actively recruiting candidates at this moment."

Answered by AI

Are there any limitations on how many people can enroll in this research project?

"This study has already reached its recruitment goal and is no longer actively looking for participants. The trial was posted on April 26th, 2018 and edited for the last time on October 7th, 2022. For those still exploring their options, there are 478 clinical trials currently recruiting patients with asthma and 5 studies recruiting patients for Ifetroban."

Answered by AI

Is this the first time Ifetroban has been used in a clinical setting?

"Ifetroban is being researched in 5 different ongoing trials, none of which are Phase 3. Most of the Ifetroban research is taking place in Nashville, but there are a total of 46 trial locations."

Answered by AI

Ifetroban: How risky is it for human health?

"While Phase 2 trials are not as rigorous as those in later phases, there is still some data supporting Ifetroban's safety."

Answered by AI

Given my current health status, can I join the ranks of this investigation?

"This clinical trial is testing a new medication for asthma patients who also have an allergy to aspirin. To be eligible, participants must between 18 and 70 years old. A total of 38 people are needed for this study."

Answered by AI

Are patients over the age of 30 eligible for this clinical trial?

"The age requirements for this particular trial are that potential participants must be between 18-70 years old. There are 135 other trials available for patients who are underaged and 343 clinical trials specifically designed for elderly patients."

Answered by AI

Is this a unique clinical trial?

"Ifetroban has been studied since 2017, with the first study being sponsored by Cumberland Pharmaceuticals. Following the initial trial in 2017, which involved 34 patients, Ifetroban received its Phase 2 drug approval. As of now, there are 5 active studies for Ifetroban taking place across 33 cities in 2 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban
Elliot Israel, MD 2018. "Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03326063.
~5 spots leftby Apr 2025
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