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Review
. 2018 Jun;14(2):93-98.
doi: 10.1183/20734735.002018.

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

Norrice M Liu  1 , Wim van Aalderen  1 , Karin C L Carlsen  1 , Courtney Coleman  1 , James D Chalmers  1 , Steve Cunningham  1 , Ricardo M Fernandes  1 , Louise J Fleming  1 , Monika Gappa  1 , Bülent Karadag  1 , Fabio Midulla  1 , Marielle W H Pijnenburg  1 , Niels W Rutjes  1 , Franca Rusconi  1 , Jonathan Grigg  1
Affiliations
Review

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

Norrice M Liu et al. Breathe (Sheff). 2018 Jun.

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-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.

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Conflict of interest statement

Conflict of interest: N.M. Liu has nothing to disclose. Conflict of interest: W. van Aalderen has nothing to disclose. Conflict of interest: K.C.L. Carlsen has received financial support from governmental and other bodies for studies not related to the present project, andhas no conflict of interest to declare. Conflict of interest: C. Coleman is an employee of the European Lung Foundation. Conflict of interest: J.D. Chalmers reports grants and personal fees from Glaxosmithkline (research grants for COPD), Boehringer-Ingelheim (research grants for COPD studies), Pfizer (research grants for COPD), Bayer Healthcare (research into bronchiectasis) and Grifols (research into bronchiectasis); grants from AstraZeneca (research grants for COPD); personal fees from Napp (for consulting), outside the submitted work. Conflict of interest: S. Cunningham has nothing to disclose. Conflict of interest: R.M. Fernandes has nothing to disclose. Conflict of interest: L.J. Fleming reports other from Novartis (lecture fees and advisory board fees paid to her institution), Vectura (consultancy fees, paid to her institution), Boehringer Ingelheim (advisory board fees, paid to her institution) and AstraZeneca (lecture fees paid to her institution), outside the submitted work. Conflict of interest: M. Gappa reports personal fees from GSK (advisory board), Boehringer (advisory board and speaker honorarium) and Novartis (advisory board and speaker honorarium), outside the submitted work. Conflict of interest: B. Karadag has nothing to disclose. Conflict of interest: F. Midulla has nothing to disclose. Conflict of interest: M.W.H. Pijnenburg has nothing to disclose. Conflict of interest: N.W. Rutjes has nothing to disclose. Conflict of interest: F.Rusconi has nothing to disclose. Conflict of interest: J. Grigg reports personal fees (honorarium for advisory board) from GSK and Vifor Pharmaceuticals, outside the submitted work.

Figures

Figure 1
Figure 1
The SPACE registry data collection platform.
See this image and copyright information in PMC

References

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