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A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo- Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps (ORCHID)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507987-38-00
Acronym
D3252C00002
Enrollment
79
Registered
2024-02-14
Start date
2021-10-14
Completion date
2024-12-18
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe CRSwNP patients with asthma.

Brief summary

Change form baseline in endoscopic total nasal polyp score (NPS), Change form baseline in mean nasal blockage score(NBS)

Detailed description

• Change from baseline in difficulty with sense of smell (DSS) score, • Change from baseline in Lund Mackay score, • Change from baseline in SinoNasal Outcome Test (SNOT-22) score., • Time to first nasal polyp surgery, • Time to first SCS course for NP, • Change from baseline in nasal symptom score(s), Time to first NP surgery and/or SCS use for CRSwNP., Proportion of patients with NP surgery and/or SCS use for CRSwNP.

Interventions

DRUGMometasonfuroaat Teva 50 microgram/verstuiving
DRUGneusspray
DRUGsuspensie
DRUGMometasonfuroat-ratiopharm® 50 Mikrogramm/Sprühstoß Nasenspray
DRUGSuspension
DRUGPlacebo for benralizumab for clinical trials is a sterile liquid solution presented in an accessorized prefilled syringe (apfs) for subcutaneous injection.
DRUGFasenra 30 mg solution for injection in pre-filled syringe

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change form baseline in endoscopic total nasal polyp score (NPS), Change form baseline in mean nasal blockage score(NBS)—

Secondary

MeasureTime frame
• Change from baseline in difficulty with sense of smell (DSS) score, • Change from baseline in Lund Mackay score, • Change from baseline in SinoNasal Outcome Test (SNOT-22) score., • Time to first nasal polyp surgery, • Time to first SCS course for NP, • Change from baseline in nasal symptom score(s), Time to first NP surgery and/or SCS use for CRSwNP., Proportion of patients with NP surgery and/or SCS use for CRSwNP.—

Countries

Belgium, Bulgaria, Hungary, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026