Asthma Research in Children and Adolescents

Active, not recruitingOBSERVATIONAL
Enrollment

525

Participants

Timeline

Start Date

July 26, 2017

Primary Completion Date

October 31, 2025

Study Completion Date

December 31, 2030

Conditions
Persistent AsthmaAsthma in ChildrenAsthma Exacerbation
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).

Trial Locations (15)

11408

Centro de Salud de Jerez Sur, Cadiz

28005

Centro de Salud Segovia, Madrid

28022

Centro de Salud Canillejas, Madrid

28934

Centro de Salud Dos de Mayo Móstoles, Madrid

39300

Centro de Salud Dobra, Torrelavega

41006

Centro de Salud La Candelaria, Seville

46021

Centro de Salud República de Argentina, Valencia

50009

Hospital Miguel Servet, Zaragoza

500013

Centro de Salud Torre Ramona, Zaragoza

01009

Hospital Universitario Araba, Alava

08003

Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona

Hospital del Mar, Barcelona

08005

Centro de Atención Primaria de la Vila Olímpica, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

08208

Hospital Parc Taulí, Barcelona

All Listed Sponsors
lead

Parc de Salut Mar

OTHER

NCT04480242 - Asthma Research in Children and Adolescents | Biotech Hunter | Biotech Hunter