Comparison of Biologicals in Treatment of Severe Asthma

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.

Full Title of Study: “Comparison of Biologicals in Treatment of Severe Asthma – Real Life Experiences”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: October 1, 2019

Detailed Description

Investigators collect and analyse results of anti-IL5/IL5R and anti-IgE therapies in asthma until October 2019. 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.

Interventions

  • Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab
    • mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma

Arms, Groups and Cohorts

  • anti-IL5/IL5R-therapy group
    • Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R
  • anti-IgE-therapy group
    • Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy

Clinical Trial Outcome Measures

Primary Measures

  • Change in number of exacerbations of the participants
    • Time Frame: Change from baseline (12 months before biologicals) at the latest 12 months after initiation of biologicals
    • Exacerbations of asthma estimated as number of courses of oral corticosteroids

Secondary Measures

  • Change in Oral corticosteroid dose
    • Time Frame: Change from baseline (at the time of the last outpatient before starting biologicals) at the latest outpatient visit after
    • Oral corticosteroid dose in milligrams
  • Change in the number of courses of antimicrobics
    • Time Frame: Change from baseline (at 12 months before biologicals) at the latest 12 months after initiation of biologicals
    • Use of antimicrobics for respiratory infections
  • Change in the number of emergency room visits of the participants
    • Time Frame: Change for baseline (at 12 months before biologicals) at the latest 12 months after initiation of biologicals
    • Emergency room visits

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Helsinki University Central Hospital
  • Collaborator
    • Foundation of Ida Montin, Tb foundation of Finland
  • Provider of Information About this Clinical Study
    • Principal Investigator: Paula Kauppi, MD, PhD, Principal Investigator – Helsinki University Central Hospital
  • Overall Official(s)
    • Paula Kauppi, MD, PhD, Principal Investigator, Helsinki University Central Hospital

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