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Comparison of Biologicals in Treatment of Severe Asthma

NCT ID: NCT04158050

Last Updated: 2023-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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anti-IL5/IL5R-therapy group

Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R

IL5 Antagonist or anti-IL5R-antibody or Omalizumab

Intervention Type DRUG

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

IL5 Antagonist or anti-IL5R-antibody or Omalizumab

Intervention Type DRUG

mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma

Interventions

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IL5 Antagonist or anti-IL5R-antibody or Omalizumab

mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ida Montini Foundation

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Paula Kauppi, MD, PhD

Chief Specialist of Allergy Department, Principal Investigator, Adj Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paula Kauppi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 32467765 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HUS/25/2019

Identifier Type: -

Identifier Source: org_study_id