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NCT Number: NCT04158050

Comparison of Biologicals in Treatment of Severe Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Central Hospital

Helsinki, 00029, Finland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IL5 Antagonist or anti-IL5R-antibody or Omalizumab

Drug

mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma

Primary outcomes

  1. Change in Number of Exacerbations of the Participants

    Time frame: 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 outcomes

  1. 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 oral corticosteroid dose in milligrams

  2. 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 courses of antimicrobics

  3. 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

    Change in the number of emergency room visits of the participants

Other outcomes

  1. Change in Number of Polypectomy, FESS and Ethmoidectomy

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

    Change in number of Polypectomy, FESS and ethmoidectomy

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Ida Montini Foundation

Registry information

Official study title

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

Acronym: BiSA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2019
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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