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ACTIVE NOT RECRUITING
NCT04480242

Asthma Research in Children and Adolescents

Sponsor: Parc de Salut Mar

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

DRUG

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).

DRUG

Inhaler device

Pressurized metered-dose inhalers (pMDIs), Breath-actuated pMDIs, Dry powder inhalers (DPIs), Nebulizers, Soft Mist Inhalers.

BEHAVIORAL

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