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Clinical trial

Comparison of Biologicals in Treatment of Severe Asthma - Real Life Experiences

ID
Name
HUS/25/2019
Description
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.
Trial arms
Trial start
2018-01-01
Estimated PCD
2020-10-31
Trial end
2020-10-31
Status
Completed
Treatment
IL5 Antagonist or anti-IL5R-antibody or Omalizumab
mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
Arms:
anti-IL5/IL5R-therapy group, anti-IgE-therapy group
Size
64
Primary endpoint
Change in Number of Exacerbations of the Participants
baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}
Updated at
2023-12-04

1 organization

1 product

1 indication

Organization
Helsinki University Central Hospital
Product
Omalizumab
Indication
Asthma