Phase 3
N=98
Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma
Nasal Polyps
Bottom Line
View on ClinicalTrials.gov: NCT03681093 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change From Baseline in Nasal Polyp Score at Week 16 — 0.20; -0.10; 0.14 score on scale — p=0.979
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fevipiprant 150 mg (Drug); Fevipiprant 450 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Nasal Polyp Score at Week 16 |
0.20; -0.10; 0.14 | 0.979 |
| SECONDARY Change From Baseline in Nasal Congestion Score at Week 16 |
-0.15; -0.35; -0.80 | 0.012 sig |
| SECONDARY Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at Week 16 |
-3.23; -10.61; -8.44 | 0.288 |
| SECONDARY Change From Baseline in Sense of Smell as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT) at Week 16 |
1.05; 4.95; 0.44 | 0.735 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03681093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.