Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

525

participants targeted

Target at P75+ for all trials

Timeline

57mo left

Started Jul 2017

Longer than P75 for all trials

Geographic Reach

1 country

15 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

13.4 years study duration

Study Progress65%

Jul 2017Dec 2030

Study Start

First participant enrolled

July 26, 2017

Completed

3 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2020

Completed

8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed

5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected

Last Updated

July 31, 2025

Status Verified

May 1, 2025

Enrollment Period

8.3 years

First QC Date

July 13, 2020

Last Update Submit

July 29, 2025

Conditions

Persistent Asthma Asthma in Children Asthma Exacerbation

Outcome Measures

Primary Outcomes (3)

Change from baseline in symptoms control, measured with the Asthma Control Questionnaire (ACQ)
Symptoms control is measured with the Asthma Control Questionnaire (ACQ-symptoms) only, which assesses the frequency of 5 asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, and wheeze) during the previous week on a 7-point Likert scale from 0 (no impairment) to 6 (maximum impairment). The overall score, calculated as the mean of item responses, ranges from 0 to 6. A score \>1.5 is considered not well-controlled asthma, and scores \<0.75 well-controlled asthma.
2, 5, 7 and 10 years after inclusion
Change from baseline in Health-Related Quality of Life, measured with the EuroQol
The EQ-5D consists of 5 dimensions ("mobility", "looking after myself", "doing usual activities", "having pain/discomfort" and "feeling worried/sad/unhappy). It includes also a visual analogue scale (EQ-VAS) on the general health status from 0 (worst health status) to 100 (best health status possible). The EQ-5D index ranges from 1 (best health state) to negative values (health states valued as worse than death), where 0 is equal to death, allowing the calculation of Quality-Adjusted Life-Years (QALYs).
2, 5, 7 and 10 years after downloading the ARCA app
Number of severe asthmatic exacerbations
As a screening to detect asthma exacerbation, the experience of asthma worsening question is administered through the ARCA app: "In the last month, have you had to take any pill, syrup, oral solution or go to the doctor or hospital, due to asthma worsening?" (Yes/No). If the answer is "yes", a phone call confirms or discards a severe asthma exacerbation through the following questions: "Did you visit or phone your general practitioner, out-of-hours, or walk-in center because your asthma got worse?", "Did you call an ambulance or go to the hospital because of your asthma?", "Did you take steroids tablets (such as Prednisolone or Deltacortril) for at least 2 days because of your asthma?" If the participant answers "yes" to at least one of the 3 questions, an asthma exacerbation is confirmed. These questions were constructed applying the definition of the American Thoracic Society and the European Respiratory Society.
5 and 10 years after inclusion

Secondary Outcomes (3)

Change from baseline in adherence to the treatment, measured with the Medication Intake Survey adherence scale-Asthma (MIS-A)
2, 5, 7 and 10 years after inclusion
Change from baseline in quality of the inhaler technique, measured with the Inhalation Technique Scale
2, 5, 7 and 10 years after downloading the ARCA app
Change from baseline in the Pediatric Asthma Impact Scale (PAIS)
2, 5, 7 and 10 years after downloading the ARCA app

Study Arms (1)

Asthma Research in Children and Adolescents - Spanish Cohort

Groups defined according to treatments prescribed during regular clinical practice and to the exposure to inhalation techniques monitoring

Drug: Inhaled Corticosteroids (ICs)Drug: Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA)Drug: Other treatmentsDrug: Inhaler deviceBehavioral: Regularly monitoring of the Inhalation technique through mobile app

Interventions

Inhaled Corticosteroids (ICs)DRUG

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.

Also known as: Treatments prescribed during regular clinical practice