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

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dc.contributor.authorKARADAĞ, BÜLENT TANER
dc.contributor.authorsLiu, 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, Bulent; Midulla, Fabio; Pijnenburg, Marielle W. H.; Rutjes, Niels W.; Rusconi, Franca; Grigg, Jonathan
dc.date.accessioned2022-03-10T11:39:44Z
dc.date.available2022-03-10T11:39:44Z
dc.date.issued2018-06
dc.description.abstractThe 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-controlled 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 at 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 into 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.
dc.identifier.doi10.1183/20734735.002018
dc.identifier.eissn2073-4735
dc.identifier.issn1810-6838
dc.identifier.pubmed29875828
dc.identifier.urihttps://hdl.handle.net/11424/219910
dc.identifier.wosWOS:000434262800004
dc.language.isoeng
dc.publisherEUROPEAN RESPIRATORY SOC JOURNALS LTD
dc.relation.ispartofBREATHE
dc.rightsinfo:eu-repo/semantics/openAccess
dc.titleSevere Paediatric Asthma Collaborative in Europe (SPACE): protocol for a European registry
dc.typereview
dspace.entity.typePublication
local.avesis.id9959d355-ab74-4a86-b76d-d4e6e9d71762
local.import.packageSS4
local.indexed.atWOS
local.indexed.atSCOPUS
local.journal.numberofpages7
oaire.citation.endPage99
oaire.citation.issue2
oaire.citation.startPage93
oaire.citation.titleBREATHE
oaire.citation.volume14
relation.isAuthorOfPublication218b489d-97ab-49dd-9db6-0c2a732f1999
relation.isAuthorOfPublication.latestForDiscovery218b489d-97ab-49dd-9db6-0c2a732f1999

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