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

Recruiting

• Conditions: Asthma

• Registration Number: NCT05706597
• Lead Sponsor: Medical Centre Leeuwarden

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study Start: 2022-12-02
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Study First Posted: 2023-01-31
• Last Update Posted: 2023-01-31
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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?

Trial Locations

Locations (1)

Medical Center Leeuwarden; 🇳🇱 Leeuwarden, Netherlands