Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2020-06-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant 150 mg and 450 mg, compared with placebo, as add-on to nasal spray standard-of-care (SoC), in reducing endoscopic nasal polyp score in adult (≥ 18 years) patients with nasal polyposis and concomitant asthma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video

NCT03591068

Nasal Polyposis

COMPLETED PHASE3

Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis

NCT02743871

Healthy Chronic Rhinosinusitis With Nasal Polyps Atopic Dermatitis

COMPLETED PHASE1

An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis

NCT01920893

Nasal Polyps

COMPLETED PHASE2

OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps

NCT03747458

Bilateral Nasal Polyposis

RECRUITING PHASE3

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps

NCT03781804

Chronic Rhinosinusitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This was a Phase 3b, Proof-of-concept study with a randomized, multicenter, double-blind, placebo-controlled, parallel-group study design to determine the ability of fevipiprant plus standard of care (SoC) compared to placebo plus SoC to reduce the size of nasal polyps. The study enrolled adult male and female patients diagnosed with nasal polyposis with a nasal polyp score assessed by nasal endoscopy ≥ 4 at baseline with a minimum score of 2 in each nostril and a concomitant diagnosis of asthma. Patients who meet the inclusion/exclusion criteria were randomized in 1:1:1 ratio in either of the 3 arms fevipiprant 450 mg dose once daily (o.d.), fevipiprant 150 mg dose o.d. or placebo o.d. in addition to SoC (mometasone furoate spray).

The study included:

* a Screening period of 2 weeks to assess eligibility
* a Run-in period of 4 weeks where patients utilized mometasone furoate spray (200 μg once daily, administered as two 50 μg actuations into each nostril)
* a Treatment period of 16 weeks. Patients continued to use the mometasone furoate SoC throughout the treatment period.
* a Follow-up period of 2 weeks following the last dose of study drug to collect additional data for safety variables.

The purpose of this study was to evaluate the efficacy and safety of fevipiprant 150 mg and 450 mg compared to placebo in the reduction of nasal polyps size and the effect on symptoms, quality of life and smell via patient-reported outcomes in patients with nasal polyposis and concomitant asthma.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasal Polyps

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double blind, double dummy study design.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fevipiprant 150 mg

Fevipiprant (QAW039) 150 mg once daily orally

Group Type EXPERIMENTAL

Fevipiprant 150 mg

Intervention Type DRUG

Fevipiprant (QAW039) 150 mg once daily administered orally as tablet

Fevipiprant 450 mg

Fevipiprant (QAW039) 450 mg once daily orally

Group Type EXPERIMENTAL

Fevipiprant 450 mg

Intervention Type DRUG

Fevipiprant (QAW039) 450 mg once daily administered orally as tablet

Placebo

Placebo once daily orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily administered orally as tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fevipiprant 150 mg

Fevipiprant (QAW039) 150 mg once daily administered orally as tablet

Intervention Type DRUG

Fevipiprant 450 mg

Fevipiprant (QAW039) 450 mg once daily administered orally as tablet

Intervention Type DRUG

Placebo

Placebo once daily administered orally as tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score \>= 4 with minimum score of 2 in each nostril.
* Concomitant diagnosis of asthma for a period of at least 6 months prior to screening.
* Patients on stable asthma treatment of at least inhaled corticosteroids (any dose) alone for at least 6 months prior to screening or ICS for 6 months prior to screening with any required, inhaled medication (LABA, LAMA) added at least 6 weeks prior to screening.

Exclusion Criteria

* Asthma exacerbation, within 6 weeks prior to screening, that required systemic corticosteroids, hospitalization or emergency room visit.
* Chronic/maintenance use of oral corticosteroids (OCS) defined as any continuous use of OCS for a period of 1 month or more, within 1 year of screening
* Use of biologics for asthma or any other indications, that has the potential to interfere/affect either asthma or nasal polyposis disease progression, within 6 months of screening.
* Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30 days of screening or during the run-in period.
* Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of screening.
* History of nasal surgery modifying the structure of the nose such that assessment of the nasal polyp score is not possible.
* Patients with baseline ACQ-5≥1.5

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No