NCT06617754

Brief Summary

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".

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Mar 2025Jan 2032

First Submitted

Initial submission to the registry

September 26, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

4.8 years

First QC Date

September 26, 2024

Last Update Submit

April 6, 2025

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Keywords

CRSwNPAsthmaBiologic treatmentEffect of treatmentDifferent geographic collection

Outcome Measures

Primary Outcomes (4)

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

    The success rate indicated by a significant change in health-related quality of life related to nasal symptoms measured with the questionnaire SNOT22.

    6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up

  • Change in Nasal Polyp Score (NPS)

    The NPS scale ranges from 0 (no polyp) to 4 (large polyps) for each nostril. The total score ranging from 0-8.

    6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up

  • Change in visual analogue scale (VAS)

    Change in VAS related to nasal symptoms. Minimum score = 0 and maximum score = 10. High score indicates worse nasal symptoms

    6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up

  • Change in olfactory function

    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.

    6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up

Study Arms (13)

Patients from Danish registry of global airways

Patients included in the Danish Global Airways Registry

Biological: Biologic drugs

Patients from the Belgian registry of global airways

Patients included in the Belgian Global Airways Registry

Biological: Biologic drugs

Patients from the Netherlands registry of global airways

Patients included in the Netherlands registry of global airways

Biological: Biologic drugs

Patients from the German registry of global airways

Patients included in the German registry of global airways

Biological: Biologic drugs

Patients from the Swiss registry of global airways

Patients included in the Swiss registry of global airways

Biological: Biologic drugs

Patients from the Italian registry of global airways

Patients included in the Italian registry of global airways

Biological: Biologic drugs

Patients from the Portuguese registry of global airways

Patients included in the Portuguese registry of global airways

Biological: Biologic drugs

Patients from the Finnish registry of global airways

Patients included in the Finnish registry of global airways

Biological: Biologic drugs

Patients from the US registry of global airways

Patients included in the US registry of global airways

Biological: Biologic drugs

Patients from the Australian registry of global airways

Patients included in the Australian registry of global airways

Biological: Biologic drugs

Patients from Spanish registry of global airways

Patients included in the Spanish Global Airways Registry

Patients from Polish registry of global airways

Patients included in the Polish Global Airways Registry

Biological: Biologic drugs

Patients from French registry of global airways

Patients included in the French Global Airways Registry

Biological: Biologic drugs

Interventions

Biologic drugsBIOLOGICAL

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

Patients from Danish registry of global airwaysPatients from French registry of global airwaysPatients from Polish registry of global airwaysPatients from the Australian registry of global airwaysPatients from the Belgian registry of global airwaysPatients from the Finnish registry of global airwaysPatients from the German registry of global airwaysPatients from the Italian registry of global airwaysPatients from the Netherlands registry of global airwaysPatients from the Portuguese registry of global airwaysPatients from the Swiss registry of global airwaysPatients from the US registry of global airways

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In Denmark, the study population consists of patients suffering CRSwNP and treated with biologic treatments included in global airways Danish/National registry. In the other countries, the study population consists of patients suffering CRSwNP and treated with biologic treatments who are included in local Registries.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rhinolaryngology Head & Neck surgery and Audiology

Copenhagen, Denmark, DK-2100, Denmark

Location

MeSH Terms

Conditions

Asthma

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, DMSci, Professor

Study Record Dates

First Submitted

September 26, 2024

First Posted

September 27, 2024

Study Start

March 31, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2032

Last Updated

April 8, 2025

Record last verified: 2025-04

Locations

DK(1)