Comparison of Biologicals in Treatment of Severe Asthma (BiSA)

February 28, 2023 updated by: Paula Kauppi, MD, PhD, Helsinki University Central Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Asthma patients that have received biologicals (anti-IL5/IL5R or anti-IgE) for asthma with or without chronic rhinitis and nasal polyps.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
anti-IL5/IL5R-therapy group
Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R
Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab
mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
anti-IgE-therapy group
Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy
Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab
mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The baseline (before biologicals) and the latest 12 months after initiation of biologicals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

Ida Montini foundation, www.tb-foundation.org

Investigators

  • Principal Investigator: Paula Kauppi, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

November 3, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (Actual)

November 8, 2019

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/25/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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