Clinical trial NCT04158050: Comparison of Biologicals in Treatment of Severe Asthma
Official title: Comparison of Biologicals in Treatment of Severe Asthma - Real Life Experiences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Ida Montini Foundation
First posted: 2019-11-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Number of Exacerbations of the Participants
timeFrame: baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)
Secondary outcomes:
measure: Change in Oral Corticosteroid Dose in Milligrams
timeFrame: 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"
measure: Change in the Number of Courses of Antimicrobics
timeFrame: The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals
measure: Change in the Number of Emergency Room Visits of the Participants
timeFrame: The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals
Other outcomes:
measure: Change in Number of Polypectomy, FESS and Ethmoidectomy
timeFrame: The baseline (before biologicals) and the latest 12 months after initiation of biologicals
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Paula Kauppi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kotisalmi E, Hakulinen A, Makela M, Toppila-Salmi S, Kauppi P. A comparison of biologicals in the treatment of adults with severe asthma - real-life experiences. Asthma Res Pract. 2020 May 13;6:2. doi: 10.1186/s40733-020-00055-9. eCollection 2020.