Ignite Creation Date:
2024-05-06 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03681093
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2018-09-20
Brief Title:
Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
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 Polyp Size in Patients With Nasal Polyposis and Concomitant Asthma
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THUNDER
Brief 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
Detailed Description:
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 inclusionexclusion criteria were randomized in 111 ratio in either of the 3 arms fevipiprant 450 mg dose once daily od fevipiprant 150 mg dose od or placebo od 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002073-22 | EUDRACT_NUMBER | None | None |