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Asthma Research in Children and Adolescents
Sponsor: Parc de Salut Mar
Summary
The purpose of this study is to assess the evolution of disease control, health-related quality of life, and the risk of severe asthma exacerbations in children and adolescents with persistent asthma in Spain at short, mid and long-term follow-up. Patient-reported information in this project is collected by computer assisted telephone interviews (CATI) and a mobile application (ARCA App).
Official title: Assessment of Children and Adolescents With Asthma: An Observational Prospective Study
Key Details
Gender
All
Age Range
6 Years - 14 Years
Study Type
OBSERVATIONAL
Enrollment
525
Start Date
2017-07-26
Completion Date
2030-12-31
Last Updated
2025-07-31
Healthy Volunteers
No
Interventions
Inhaled Corticosteroids (ICs)
Any corticosteroid (beclomethasone, budesonide, ciclesonide, fluticasone propionate, fluticasone furoate, mometasone, and triamcinolone) prescribed by the pediatrician as an inhaled controller medication, for daily management of asthma. The daily dose of ICs prescribed will be translated into beclomethasone equivalent.
Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA)
Beclomethasone/formoterol, budesonide/formoterol, fluticasone furoate/vilanterol, fluticasone propionate/formoterol, fluticasone propionate/salmeterol, and mometasone/formoterol. Any of these combinations prescribed by the pediatrician as an inhaled controller medication, for daily management of asthma.
Other treatments
Low-dose oral corticosteroids, long-acting muscarinic antagonist (tiotropium), low-dose macrolides (azithromycin), leukotrienes receptor antagonists (i.e. montelukast), or biologic agents (i.e. omalizumab).
Inhaler device
Pressurized metered-dose inhalers (pMDIs), Breath-actuated pMDIs, Dry powder inhalers (DPIs), Nebulizers, Soft Mist Inhalers.
Regularly monitoring of the Inhalation technique through mobile app
App users are randomized within each pediatrician into two groups of equal size defined within the subsample recruited, so that 50% of the participants are allocated to answer the inhalation techniques, and the other 50% are allocated to answer the environment support scales. Once the app is downloaded, at month 2 and every 6 months thereafter the intervention group answers the inhalation techniques scale (group 1) and the control group answers the environment support scale (group 2).
Locations (15)
Centro de Salud de Jerez Sur
Cadiz, Andalusia, Spain
Centro de Salud La Candelaria
Seville, Andalusia, Spain
Centro de Salud Torre Ramona
Zaragoza, Aragon, Spain
Hospital Miguel Servet
Zaragoza, Aragon, Spain
Hospital Universitario Araba
Alava, Basque Country, Spain
Centro de Salud Dobra
Torrelavega, Cantabria, Spain
Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute
Barcelona, Catalonia, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Centro de Atención Primaria de la Vila Olímpica
Barcelona, Catalonia, Spain
Hospital Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Parc Taulí
Barcelona, Catalonia, Spain
Centro de Salud Segovia
Madrid, Madrid, Spain
Centro de Salud Canillejas
Madrid, Madrid, Spain
Centro de Salud Dos de Mayo Móstoles
Madrid, Madrid, Spain
Centro de Salud República de Argentina
Valencia, Valencia, Spain