Similarities and Differences of Biological Therapies for Severe Asthma.
1 other identifier
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedStudy Start
First participant enrolled
April 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedApril 27, 2021
December 1, 2020
1.6 years
December 1, 2020
April 23, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
Treatment dose scheduling and changes of dose throughout the study.
2 years after inclusion
Number of treatment discontinuations and causes of interruption throughout the study.
2 years after inclusion
Incidence of Relevant Treatment-Related Adverse Events recorded throughout the study.
2 years after inclusion
Severity of Treatment-Related Adverse Events recorded throughout the study.
2 years after inclusion
Change of asthma control during the treatment.
Number of asthma exacerbations, change in FEV1, ACT, and blood eosinophilia, need of add-on medication, inhaled medication and systemic corticosteroids.
2 years after inclusion
Study Arms (2)
Standard of care
Patients with severe asthma being treated with non-biological standard therapies, mainly systemic corticosteroids.
Biological therapies
Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab.
Interventions
Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.
Omalizumab will be prescribed freely by the treating physician according to real-life conditions.
Reslizumab will be prescribed freely by the treating physician according to real-life conditions.
Benralizumab will be prescribed freely by the treating physician according to real-life conditions.
Dupilumab will be prescribed freely by the treating physician according to real-life conditions.
Eligibility Criteria
All patients, adults and children, with a diagnosis of severe asthma in the participating centers.
You may qualify if:
- 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.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clinica Universidad de Navarra, Universidad de Navarralead
- Hospital Clinic of Barcelonacollaborator
- Hospital Regional de Malagacollaborator
Study Sites (1)
Hospital Civil-Hospital Regional Universitario de Málaga
Málaga, 29009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2020
First Posted
December 11, 2020
Study Start
April 7, 2021
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
April 27, 2021
Record last verified: 2020-12