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Thromboxane Receptor Antagonist

Oral Ifetroban for AERD

Phase 2

Waitlist Available

Led By Andrew White, MD

Research Sponsored by Cumberland Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years of age

History of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or one reaction that was life-threatening and required hospitalization, or a diagnosis of AERD by a physician-conducted challenge to aspirin in the last five years before starting treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial will test ifetroban, a drug designed to treat AERD, is safe and effective. AERD is a disease that causes asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.

Who is the study for?

Adults with aspirin-exacerbated respiratory disease (AERD), which includes asthma and nasal polyps, who've had bad reactions to NSAIDs. Participants must have stable asthma, not be current smokers or pregnant, and can't be using certain medications like long-acting antihistamines or high-dose steroids.Check my eligibility

What is being tested?

The trial is testing ifetroban capsules against placebo to see if they're safe and effective for AERD. It's a phase 2 study where participants are randomly assigned to receive either the actual drug or a dummy pill without any active ingredients.See study design

What are the potential side effects?

While specific side effects of ifetroban aren't listed here, common ones in trials may include digestive issues, headaches, dizziness, potential allergic reactions, and possibly bleeding risks due to its anti-inflammatory properties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I've had severe reactions to aspirin or similar drugs, including breathing problems.

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I have severe nasal symptoms as shown by my SNOT-22 score.

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I have had nasal polyps.

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I have been diagnosed with asthma by a doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Sino-Nasal Outcome Test-22 score

Secondary outcome measures

Change From Baseline in Asthma Control Questionnaire -7 score

Change From Baseline in FEV1

Change From Baseline in FeNO

+4 more

Other outcome measures

Change From Baseline in blood, urine and nasal epithelial biomarkers

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ifetroban Oral CapsuleExperimental Treatment1 Intervention

Oral ifetroban, 200 mg daily for 8 weeks

Group II: Placebo Oral CapsulePlacebo Group1 Intervention

Oral placebo daily for 8 weeks

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cumberland PharmaceuticalsLead Sponsor

62 Previous Clinical Trials

9,387 Total Patients Enrolled

Andrew White, MDPrincipal InvestigatorScripps Research Institute

Media Library

Ifetroban Oral Capsule (Thromboxane Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03028350 — Phase 2

Asthma Research Study Groups: Placebo Oral Capsule, Ifetroban Oral Capsule

Asthma Clinical Trial 2023: Ifetroban Oral Capsule Highlights & Side Effects. Trial Name: NCT03028350 — Phase 2

Ifetroban Oral Capsule (Thromboxane Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03028350 — Phase 2

Frequently Asked Questions

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

What risks are associated with Ifetroban Oral Capsule ingestion?

"Our team at Power gave Ifetroban Oral Capsule a score of 2 since it is still in Phase 2, so there has been some safety data collected but none for efficacy."

Answered by AI

What is the breadth of medical institutions that are conducting this research?

"This research is recruiting participants at Vanderbilt University Medical Centre in Nashville, Advanced ENT & Allergy located in Louisville, and the University of Pennsylvania situated in Philadelphia. There are also 7 other sites joining this study."

Answered by AI

Has this research ever been conducted before?

"The initial study of Ifetroban Oral Capsule, which was sponsored by Cumberland Pharmaceuticals and included 76 participants, commenced in 2017. Subsequently, the drug received Phase 2 approval. Currently, 4 active trials related to Ifetroban are being conducted across 27 cities and one nation."

Answered by AI

What is the aggregate number of individuals participating in this trial?

"No longer actively enrolling patients, this clinical trial was initially posted on July 17th 2017 and last updated November 16th 2022. Those seeking medical studies can find 83 asthma trials and 4 Ifetroban Oral Capsule investigation currently recruiting participants."

Answered by AI

Could you please elucidate any other experiments conducted on Ifetroban Oral Capsule?

"The pharmaceutical drug Ifetroban Oral Capsule was first investigated at Rochester Regional Health in 2017, with 37 trials having since come to a conclusion. Currently, four studies are underway; many of these occurring within the Nashville, Tennessee area."

Answered by AI

Are there any vacancies left in this clinical experiment?

"It appears that the data hosted on clinicaltrials.gov indicates that this trial, which was posted in July of 2017 and last updated in November of 2022, is not actively recruiting patients at present. However, there are an additional 87 trials welcoming candidates currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)

2017. "Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03028350.

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