Comparison of Biologicals in Treatment of Severe Asthma

Completed

• Conditions: Asthma
• Interventions: Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab

• Registration Number: NCT04158050
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

This is a retrospective clinical study on adult patients (18 years or more) with biological therapy for severe asthma at the Helsinki University Central Hospital (HUCH). This is a real-life study with a broader patient population than in a randomized controlled trial. Omalizumab has been used for treatment of asthma in HUCH since January 2009, anti-IL5 therapies starting with mepolizumab since April 2016.

Detailed Description

The investigators collect and analyse results of anti-IL5/IL5R and anti-IgE therapies in asthma until October 2019.The investigators compare number of exacerbations, number of glucocorticoid courses, dose of per oral glucocorticoid, number of antibiotic courses, need of emergency care and hospitalizations because of asthma before use of biologicals and at the latest visits of the participants when using biologicals.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-11-03
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-08
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Results First Submitted: 2020-11-18
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Results First Posted: 2023-12-04
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• asthma that remains uncontrolled despite moderate to high dose inhaled corticosteroid and additional therapy with at least one other controller medication and need for continuous per oral corticosteroids (OCS) or contraindications (or clinically significant side effects of OCS) against OCS and/or frequent courses (two or more per year) of OCS

Exclusion Criteria

• patients without asthma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
anti-IL5/IL5R-therapy group	IL5 Antagonist or anti-IL5R-antibody or Omalizumab	Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R
anti-IgE-therapy group	IL5 Antagonist or anti-IL5R-antibody or Omalizumab	Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy

Primary Outcome Measures

Name	Time	Method
Change in Number of Exacerbations of the Participants	baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)	Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids.

Secondary Outcome Measures

Name	Time	Method
Change in Oral Corticosteroid Dose in Milligrams	The baseline (at the time of the last outpatient before starting biologicals) and up to approximately 12 months for Anti-IL5/IL5R Therapy and approximately 44 months for the Anti-IgE Therapy"	Change in oral corticosteroid dose in milligrams
Change in the Number of Courses of Antimicrobics	The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals	Change in the number of courses of antimicrobics
Change in the Number of Emergency Room Visits of the Participants	The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals	Change in the number of emergency room visits of the participants

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland