Similarities and Differences of Biological Therapies for Severe Asthma.

• Conditions: Asthma
• Interventions: Biological: Mepolizumab; Biological: Omalizumab; Biological: Reslizumab; Biological: Benralizumab; Biological: Dupilumab

• Registration Number: NCT04665141
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

This is an ambispective multicenter longitudinal observational study to evaluate the efficacy and safety profile of biological therapies in patients diagnosed with severe asthma in real life conditions.

Detailed Description

The use of biologicals to treat severe asthma has been implemented in a regular basis while information on long term effectiveness and safety is lacking. It is necessary to establish strategies to closely monitor the possible occurrence of reactions, adverse effects of innovative biological medicines used to treat severe asthma.

In this study the investigators want to evaluate the comparative effectiveness, utilization patterns, long-term safety, and use in special groups in real-life conditions in severe asthma.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-11
• Study Start: 2021-04-07
• Last Update Submitted: 2021-04-23
• Last Update Posted: 2021-04-27
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Individuals of any age: adults and children.
• Diagnosis of severe asthma as given by the treating physician, and defined as an asthma that remains uncontrolled in despite adherence with maximal optimized therapy and treatment of contributed factors, or asthma that worsens when high dose treatment is decreased.
• Being treated or not (control group) with biological drugs.
• Signed Informed Consent.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biological therapies	Dupilumab	Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab.
Biological therapies	Mepolizumab	Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab.
Biological therapies	Omalizumab	Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab.
Biological therapies	Reslizumab	Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab.
Biological therapies	Benralizumab	Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab.

Primary Outcome Measures

Name	Time	Method
Severity of Treatment-Related Adverse Events recorded throughout the study.	2 years after inclusion
Change of asthma control during the treatment.	2 years after inclusion	Number of asthma exacerbations, change in FEV1, ACT, and blood eosinophilia, need of add-on medication, inhaled medication and systemic corticosteroids.
Treatment dose scheduling and changes of dose throughout the study.	2 years after inclusion
Incidence of Relevant Treatment-Related Adverse Events recorded throughout the study.	2 years after inclusion
Number of treatment discontinuations and causes of interruption throughout the study.	2 years after inclusion

Trial Locations

Locations (1)

Hospital Civil-Hospital Regional Universitario de Málaga; 🇪🇸 Málaga, Spain