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Active, Not Recruiting

NCT Number: NCT06617754

International Severe CRSwNP Registry 2024-2028

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".

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rhinolaryngology Head & Neck surgery and Audiology

Copenhagen, Denmark, DK-2100

About this study

Regional or national registries have evaluated the efficacy of different biologics in severe uncontrolled CRSwNP coordinated by several academic centres in Europe. At present, these registries have not been merged nor allowed the comparison in real-life efficacy between the 3 different monoclonal antibodies (mepolizumab, dupilumab, omalizumab) with different mechanism which has been approved for the indication of CRSwNP and the effect of the nasal polyp score. Some countries have allowance for some of the different biologic drugs, other countries have other combination of the drugs. Despite the heterogeneity in availability of biologics for the indication of CRSwNP, the merge of data might lead to very interesting outcomes.

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".

Compare the outcomes of different biologics in different national registries, at screening and 6-month follow-up: Primary aims:

  • Delphi process to point at the viable of importance.
  • The speed and size of SNOT-22 reduction
  • The speed and size of NPS reduction
  • The speed and size of Nasal congestion score (NCS) reduction
  • The speed and size of smell score increase.
  • The CTscan/Lund-Mackay score response
  • The evolution of the response on VAS scale (patients)
  • The Type 2 biomarkers at entrance and during the study
  • The (non)responder percentages defined based on EUFOREA criteria
  • The use of OCS (amount and frequency)
  • The frequency and time (days) since last sinus surgery
  • The effect of biologics on comorbidities (atopic dermatitis, allergic rhinitis, asthma and NSAID intolerance) in patients with CRSwNP
  • The reduced in need of Otrivin or similar drugs
  • Differences between inclusion criteria for biologic drugs, and differences between countries.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptoms of CRSwNP
  • Indication for biologic treatment as suggested by EPOS/EUFOREA
  • Have been followed for 6 months

Exclusion criteria

  • Unilateral polyps
  • Non-Type-2 inflammation
  • Treatment less than 6 months

Treatment and study plan

Biologic drugs

Biological

Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies

Primary outcomes

  1. Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score

    Time frame: 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.

  2. Change in Nasal Polyp Score (NPS)

    Time frame: 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.

  3. Change in visual analogue scale (VAS)

    Time frame: 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

  4. Change in olfactory function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vibeke Backer

Other

Collaborators

  • The European Forum for Research and Education in Allergy and Airway Diseases

Registry information

Official study title

InternatioNal seVerE CRSwNP Registry (INVENT) 2024-2028

Acronym: INVENT

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Sep 27, 2024
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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