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- Title
Severe Paediatric Asthma Collaborative in Europe (SPACE): protocol for a European registry.
- Authors
Liu, Norrice M.; van Aalderen, Wim; Carlsen, Karin C. L.; Coleman, Courtney; Chalmers, James D.; Cunningham, Steve; Fernandes, Ricardo M.; Fleming, Louise J.; Gappa, Monika; Karadag, Biilent; Midulla, Fabio; Pijnenburg, Marielle W. H.; Rutjes, Niels W.; Rusconi, Franca; Grigg, Jonathan
- Abstract
The development of new asthma biologics and receptor blockers for the treatment of paediatric severe asthma raises challenges. It is unclear whether there are sufficient children in Europe to recruit into randomised placebo-control led trials to establish efficacy and safety in this age group. In February 2016, the European Respiratory Society funded a clinical research collaboration entitled "Severe Paediatric Asthma Collaborative in Europe" (SPACE). We now report the SPACE protocol for a prospective pan-European observational study of paediatric severe asthma. Inclusion criteria are: 1) age 6-17 years, 2) severe asthma managed a a specialised centre for >6 months, 3) clinical and spirometry evidence of asthma, and 4) reaching a pre-defined treatment threshold. The exclusion criterion is the presence of conditions which mimic asthma symptoms . Eligible children will be prospectively recruited in to a registry, recording demographics, comorbidities, quality of life, family history, neonatal history, smoking history, asthma background, investigations, and treatment. Follow-up will provide longitudinal data on asthma control and treatment changes. The SPACE registry, by identifying well-phenotyped children eligible for clinical trials, and the amount of overlap in eligibility criteria, will inform the design of European trials in paediatric severe asthma, and facilitate observational research where data from single centres are limited.
- Subjects
EUROPE; GENETICS of asthma; ASTHMA prevention; PSYCHOLOGY of asthma; CLINICAL medicine research; REPORTING of diseases; INTERPROFESSIONAL relations; MEDICAL protocols; NONPROFIT organizations; SCIENTIFIC observation; QUALITY of life; SPIROMETRY; PHENOTYPES; DISEASE management; COMORBIDITY; SEVERITY of illness index; FAMILY history (Medicine); CHILDREN
- Publication
Breathe, 2018, Vol 14, Issue 2, p93
- ISSN
1810-6838
- Publication type
Article
- DOI
10.1183/20734735.002018