Comparison of Biologicals in Treatment of Severe Asthma

NCT04158050 | Completed Results FDA Drug

• 1 other identifier: HUS/25/2019
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  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 Outcomes (1)

• Change in Number of Polypectomy, FESS and Ethmoidectomy

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

Study Arms (2)

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

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

Interventions

IL5 Antagonist or anti-IL5R-antibody or Omalizumab DRUG

mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma

anti-IL5/IL5R-therapy group; anti-IgE-therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• patients without asthma

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Ida Montini Foundation: collaborator

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Related Publications (1)

• 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.

  PMID: 32467765 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr Paula Kauppi
• Organization: Helsinki University Hospital

paula.kauppi@hus.fi

+358504286802

Study Officials

• Paula Kauppi, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Specialist of Allergy Department, Principal Investigator, Adj Prof.

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 8, 2019
• Study Start: January 1, 2018
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: December 4, 2023
• Results First Posted: December 4, 2023

Record last verified: 2023-02

Locations

FI (1)