Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma (NCT03681093) | Clinical Trial Compass
CompletedPhase 3
Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma
United States, Argentina98 participantsStarted 2019-03-26
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Change From Baseline in Nasal Polyp Score at Week 16