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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03028350
Other study ID # CPI-IFE-006
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 17, 2017
Est. completion date August 2024

Study information

Verified date August 2023
Source Cumberland Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a randomized, placebo-controlled, double-blind phase 2 trial evaluating approximately 76 subjects with symptomatic AERD on the safety and efficacy of 8 weeks of oral ifetroban treatment. Eligible AERD subjects will be randomized to receive 8 weeks of either oral ifetroban daily or matching placebo followed by a 2-week post-treatment period.


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Study Design


Intervention

Drug:
Ifetroban Oral Capsule
Subjects will be treated with oral ifetroban daily for 8 weeks
Placebo Oral Capsule
Subjects will be treated with oral placebo daily for 8 weeks

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Sponsors (1)

Lead Sponsor Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change From Baseline in blood, urine and nasal epithelial biomarkers 8 weeks
Primary Change From Baseline in Sino-Nasal Outcome Test-22 score 8 weeks
Secondary Change From Baseline in Asthma Control Questionnaire -7 score 8 weeks
Secondary Change From Baseline in Total Nasal Symptom score 8 weeks
Secondary Change From Baseline in FEV1 8 weeks
Secondary Change From Baseline in PNIFR 8 weeks
Secondary Change From Baseline in FeNO 8 weeks
Secondary Change From Baseline in rescue medication 8 weeks
Secondary Change From Baseline in antibiotic use 8 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01681615 - Challenge Test for Acetylsalicylic Acid Hypersensitivity N/A
Terminated NCT01320072 - Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease
Completed NCT01867281 - The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases Phase 4
Completed NCT02824523 - Role of Inflammatory Mediators in AERD
Completed NCT01597375 - Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin) Phase 2
Recruiting NCT04823585 - Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab) N/A
Recruiting NCT05575037 - Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease Phase 2
Completed NCT03326063 - Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban Phase 2