Severe Paediatric Asthma Collaborative in Europe (SPACE): protocol for a European registry

Area of Science:

• Pulmonology
• Clinical Research
• Paediatric Medicine

Background:

• Establishing efficacy and safety of new severe asthma biologics in children requires robust clinical trial data.
• Recruitment challenges exist for paediatric severe asthma trials in Europe due to potentially insufficient patient numbers.
• The European Respiratory Society initiated the Severe Paediatric Asthma Collaborative in Europe (SPACE) to address these challenges.

Purpose of the Study:

• To report the protocol for a prospective, pan-European observational study on paediatric severe asthma.
• To establish a registry of well-phenotyped children with severe asthma eligible for clinical trials.
• To inform the design of future European clinical trials and facilitate observational research in paediatric severe asthma.

Main Methods:

• Prospective, pan-European observational study.
• Inclusion criteria: age 6-17 years, severe asthma for ≥6 months at a specialized center, clinical/spirometry evidence, and meeting treatment thresholds.
• Exclusion criterion: conditions mimicking asthma symptoms. Data collected: demographics, comorbidities, quality of life, history, asthma details, investigations, and treatment.

Main Results:

• The SPACE protocol outlines a comprehensive approach to data collection for paediatric severe asthma.
• The registry aims to identify a cohort of eligible children for clinical trials.
• Longitudinal data on asthma control and treatment changes will be collected.

Conclusions:

• The SPACE registry will facilitate the identification of suitable candidates for clinical trials in paediatric severe asthma.
• This observational study will provide valuable insights into the feasibility of European clinical trials.
• The findings will support the development of effective treatments for children with severe asthma.