Comparison of Biologicals in Treatment of Severe Asthma

Asthma Clinical Trial

— BiSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158050
• Other study ID #: HUS/25/2019
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: February 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Ida Montini foundation, www.tb-foundation.org

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Number of Polypectomy, FESS and Ethmoidectomy	Change in number of Polypectomy, FESS and ethmoidectomy	The baseline (before biologicals) and the latest 12 months after initiation of biologicals
Primary	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.	baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)
Secondary	Change in Oral Corticosteroid Dose in Milligrams	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"
Secondary	Change in the Number of Courses of Antimicrobics	Change in the number of courses of antimicrobics	The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals
Secondary	Change in the Number of Emergency Room Visits of the Participants	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