Comparison of Biologicals in Treatment of Severe Asthma

Helsinki University Central Hospital64 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Asthma

Interventions

IL5 Antagonist or anti-IL5R-antibody or OmalizumabDRUG

mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsinki University Central Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

Change in Number of Exacerbations of the Participants

Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids.

Time frame: baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)

Secondary Outcomes

Change in Oral Corticosteroid Dose in Milligrams

Change in oral corticosteroid dose in milligrams

Time frame: 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 the Number of Courses of Antimicrobics

Change in the number of courses of antimicrobics

Time frame: 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

Change in the number of emergency room visits of the participants

Time frame: The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals

Data from ClinicalTrials.gov

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