Active — Not RecruitingNot Applicable

Asthma Research in Children and Adolescents

Spain525 participantsStarted 2017-07-26

Plain-language 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).

Who can participate

Age range6 Years – 14 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children or adolescents aged 6-14. * Clinical diagnosis of asthma. * Undergoing treatment with inhaled corticosteroids (alone or combined with long-acting beta-agonists) for more than 6 months in the previous year. * With access to a smart phone (their own, or their parents'). Exclusion Criteria: * Concomitant respiratory diseases: * Chronic obstructive pulmonary disease * Cystic fibrosis * Pulmonary fibrosis * Bronchiectasis * Active tuberculosis, * Immunodeficiency associated with alpha 1 antitrypsin deficiency * Ciliary diseases

What they're measuring

Change from baseline in symptoms control, measured with the Asthma Control Questionnaire (ACQ)

Timeframe: 2, 5, 7 and 10 years after inclusion

Change from baseline in Health-Related Quality of Life, measured with the EuroQol

Timeframe: 2, 5, 7 and 10 years after downloading the ARCA app

Number of severe asthmatic exacerbations

Timeframe: 5 and 10 years after inclusion

Trial details

NCT IDNCT04480242

SponsorParc de Salut Mar

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Persistent Asthma trials