InternatioNal seVerE CRSwNP Registry (INVENT) 2024-2028

NCT06617754 ACTIVE_NOT_RECRUITING

The objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine".

Details

Lead sponsor	Vibeke Backer
Status	ACTIVE_NOT_RECRUITING
Enrolment	3000
Start date	2025-03-31
Completion	2032-01

Conditions

• Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Interventions

• Biologic drugs

Primary outcomes

• Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score — 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
  The success rate indicated by a significant change in health-related quality of life related to nasal symptoms measured with the questionnaire SNOT22.
• Change in Nasal Polyp Score (NPS) — 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
  The NPS scale ranges from 0 (no polyp) to 4 (large polyps) for each nostril. The total score ranging from 0-8.
• Change in visual analogue scale (VAS) — 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
  Change in VAS related to nasal symptoms. Minimum score = 0 and maximum score = 10. High score indicates worse nasal symptoms
• Change in olfactory function — 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
  Change in olfactory function measured with Sniffin' Stick 16 blue. Minimum score = 0. Maximum score = 16. A score between 0-8 indicates anosmia, a score between 8-11 indicates hyposmia, and a score \>11 indicates normosmia.

Countries

Denmark