A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of fevipiprant once daily plus standard-of-care (SoC) for assessment of the efficacy in reduction of nasal polyps size in patients with nasal polyposis and concomitant asthma
- Conditions
- 10010613polyps in the noserespiratory disease
- Registration Number
- NL-OMON48110
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
- Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score 4 or more 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.
- 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.
- Patients receiving any medications in the classes listed in Table 6-1. Prohibited Medication should be excluded unless they meet the criteria as specified in Table 6-1.
- Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin 7 days prior to run-in visit. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.
- Patients on any statin therapy with a CK level >2 X ULN at Screening Visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In patients with nasal polyps with a polyp size score * 4 at baseline, to<br /><br>demonstrate a difference in mean change from baseline in polyp size at Week 16,<br /><br>measured by the nasal polyp score (NPS, assessed by nasal endoscopy with<br /><br>central reading), between fevipiprant (150 mg or 450 mg once daily, separately)<br /><br>and placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To evaluate the effect on symptoms as measured by the nasal congestion score<br /><br>(NCS) with fevipiprant (150 mg or 450 mg once daily), compared with placebo<br /><br>following 16 weeks of treatment<br /><br>- To evaluate the effect on quality of life as measured by the Sino-Nasal<br /><br>Outcome Test - 22 (SNOT-22) with fevipiprant (150 mg or 450 mg once daily),<br /><br>compared with placebo following 16 weeks of treatment.<br /><br>- To evaluate the effect on Smell as measured by the university of Pennsylvania<br /><br>smell identification test (UPSIT) with fevipiprant (150 mg or 450 mg once<br /><br>daily), compared with placebo following 16 weeks of treatment.<br /><br>- To evaluate the effect of fevipiprant 150 mg and 450 mg compared with placebo<br /><br>in terms of general safety/tolerability following 16 weeks of treatment.</p><br>