Overview

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

Status:
Completed
Trial end date:
2020-06-10
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Indoleacetic Acids
Criteria
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