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NCT05706597 Clinical Trial

Clinical Relevance of Small Airways Disease in Severe Asthma Patients Treated With Anti-InterLeukin-5 Therapy

Asthma Clinical Trial

— SAIL  

Official title:
Clinical Relevance of Small Airways Disease in Severe Asthma Patients Treated With Anti-InterLeukin-5 Therapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05706597
Other study ID # SAIL2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2, 2022
Est. completion date March 1, 2023

Study information
Verified date December 2022
Source Medical Centre Leeuwarden
Contact Akke Nynke van der Meer, MD PhD
Phone 003158-2866666
Email a.n.van.der.meer@mcl.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 110
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Severe asthma patients treated with anti-IL5/5R therapy (i.e. mepolizumab, benralizumab, reslizumab) for at least 4 months. Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Medical Center Leeuwarden Leeuwarden

Sponsors (1)
Lead Sponsor Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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