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

January 23, 2023 updated by: Medical Centre Leeuwarden
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
Time Frame: 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?
4 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Centre Leeuwarden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 2, 2022

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

March 1, 2023

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (ACTUAL)

January 31, 2023

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAIL2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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