NCT05706597

Brief Summary

The aim of this research is to investigate the extent and clinical relevance of small airways disease in severe eosinophilic asthma patients treated with anti-IL5/5R therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

December 2, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 31, 2023

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

January 23, 2023

Last Update Submit

January 23, 2023

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Is change in FEF25-75 during anti-IL5/5R treatment associated with change in asthma control (measured with the asthma control questionnaire -ACQ-) in severe eosinophilic asthma patients after 4 months and after 12 months treatment?

    Is change in FEF25-75 during anti-IL5/5R treatment associated with change in asthma control (measured with the asthma control questionnaire -ACQ-) in severe eosinophilic asthma patients after 4 months and after 12 months treatment?

    4 months and 12 months

Eligibility Criteria

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

The study population consists of all severe eosinophilic asthma patients in the MCL, treated with anti-IL5/5R therapy (i.e. mepolizumab, benralizumab, reslizumab) for at least 4 months.

You may qualify if:

  • Severe asthma patients treated with anti-IL5/5R therapy (i.e. mepolizumab, benralizumab, reslizumab) for at least 4 months.

You may not qualify if:

  • No information about lung function at baseline, or after both 4 months and 12 months.
  • No information about clinical response (i.e. number of exacerbations, reduction of mOCS/ maintenance oral corticosteroid dose, ACQ, AQLQ) after both 4 months and 12 months.
  • Treatment with another anti-IL5/5R therapy before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center Leeuwarden

Leeuwarden, Netherlands

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Akke Nynke van der Meer, MD PhD

CONTACT

003158-2866666a.n.van.der.meer@mcl.nl

Ilse Boudewijn, MD

CONTACT

003150-3616161i.m.boudewijn@umcg.nl

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

January 31, 2023

Study Start

December 2, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

January 31, 2023

Record last verified: 2022-12

Locations

NL(1)