Persistent AsthmaARCANCT04480242
Asthma Research in Children and Adolescents
An observational study of Persistent Asthma and Asthma in Children, run by Parc de Salut Mar at 15 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Persistent Asthma, Asthma in Children, Asthma Exacerbation
- What is being tested?
- Inhaled Corticosteroids (ICs), Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA) and Other treatments
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 525 participants
- Where
- 15 sitesSpain
- Study dates
- 26 Jul 2017to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Spanish children and adolescents with persistent asthma seen in the outpatient pediatric pulmonology clinics and primary care pediatricians.
Who may be able to join
- 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').
Who cannot join
- Concomitant respiratory diseases:
- Chronic obstructive pulmonary disease
- Cystic fibrosis
- Pulmonary fibrosis
- Bronchiectasis
- Active tuberculosis,
- Immunodeficiency associated with alpha 1 antitrypsin deficiency
- Ciliary diseases
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Hospital Universitario Araba
Alava, Basque Country, 01009
Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute
Barcelona, Catalonia, 08003
Hospital del Mar
Barcelona, Catalonia, 08003
Centro de Atención Primaria de la Vila Olímpica
Barcelona, Catalonia, 08005
Hospital Vall d'Hebron
Barcelona, Catalonia, 08035
Hospital Parc Taulí
Barcelona, Catalonia, 08208
Centro de Salud de Jerez Sur
Cadiz, Andalusia, 11408
Centro de Salud Segovia
Madrid, Madrid, 28005
Centro de Salud Canillejas
Madrid, Madrid, 28022
Centro de Salud Dos de Mayo Móstoles
Madrid, Madrid, 28934
Centro de Salud La Candelaria
Seville, Andalusia, 41006
Centro de Salud Dobra
Torrelavega, Cantabria, 39300
Centro de Salud República de Argentina
Valencia, Valencia, 46021
Centro de Salud Torre Ramona
Zaragoza, Aragon, 500013
Hospital Miguel Servet
Zaragoza, Aragon, 50009
About this study
Official title: Assessment of Children and Adolescents With Asthma: An Observational Prospective Study
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).
Read the detailed description
Primary Objectives:
- To evaluate the asthma control in children and adolescents with persistent asthma, and its relationship with patient characteristics, treatment and health-related variables (treatment adherence, inhalation technique, inhaler device, asthma triggers, and smoking exposure, among others).
- To assess the health-related quality of life of children and adolescents with persistent asthma, and its relationship with patient characteristics, treatment and health-related variables (asthma control, treatment adherence and inhalation technique, inhaler device, asthma triggers, and smoking exposure, among others).
- To assess the risk of severe asthma exacerbations in children and adolescents with persistent asthma and its relationship with patient characteristics, treatment, and health-related variables (asthma control, treatment adherence and inhalation technique, inhaler device, health-related quality of life, asthma triggers, and smoking exposure, among others).
Secondary Objectives:
- To evaluate the effect of monitoring inhalation techniques on patients' performance according to recommended actions when using inhalers, and outcomes such as asthma control, health-related quality of life, and asthma exacerbations.
- To assess the treatment adherence in children and adolescents with persistent asthma, and its relationship with other treatment-related factors (inhaler technique, inhaler device, adherence attitudes, and beliefs about illness, inhaler and exacerbations, among others).
- To evaluate health inequalities in children and adolescents with asthma in Spain.
ARCA is a prospective multicenter observational study in children and adolescents with a clinical diagnosis of persistent asthma. This clinical diagnosis of asthma is defined as the presence of wheezing three times in the last year that improves with the use of bronchodilators. Participants are consecutively recruited in outpatient pediatric pulmonology hospital consultations and primary care physicians.
Patient-reported information is obtained by computer-assisted telephone interviews (CATI) and a mobile application (ARCA App). Telephone interviews are performed by trained interviewers to children 8-16 years old and parents/caregivers of children 6-7 years of age, immediately after recruitment and every 6 months. It includes the evaluation of asthma control, prescribed asthma treatment, adherence, and severe asthma exacerbations. Information about inhalation techniques, socioeconomic status, smoking exposure, triggers, use of peak flow, symptom diary, perceived asthma care, adherence attitudes, and beliefs about illness, inhaler and exacerbations is also collected.
The 'ARCA app' combines 3 age versions: parents/guardians (proxy response) for children 6-7 years old, children aged 8-11 years (self-response), and adolescents aged 12-16 years (self-response). The application consists in an interactive chat, simulating a conversation by Short Message Service (SMS) or Instant Messaging Application (WhatsApp) with someone in real time. It includes the monthly administration of 2 questions (global rating of change and severe asthma exacerbations). At the beginning, after downloading the app, and every two months different standardized questionnaires are administered by turns: the EuroQol (EQ-5D), the Pediatric Asthma Impact Scale (PAIS), inhalation techniques scale, and environment support. These latter scales are administered randomly to two groups of equal size, defined within the subsample recruited by each pediatrician.
All the information that each participant answers through the app can be viewed by the pediatrician through a specific platform. The results of the different questionnaires are shown in charts reflecting the patient's answers over time, using the traffic lights code: green for good outcomes, amber for intermediate, and red for poor. Clinical data is registered at recruitment and annually during the follow-up.
Sample size: To detect differences between two groups in the Asthma Control Questionnaire score of 0.3 SD, 175 patients per group would be required to have a statistical power of 80%, at a significance level of 5%.
- Conditions
- Persistent Asthma, Asthma in Children, Asthma Exacerbation
- Being tested
- Inhaled Corticosteroids (ICs), Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA), Other treatments, Inhaler device, Regularly monitoring of the Inhalation technique through mobile app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Corticosteroids (ICs)Drug
Also called Treatments prescribed during regular clinical practice
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)Drug
Also called Treatments prescribed during regular clinical practice
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 treatmentsDrug
Also called Treatments prescribed during regular clinical practice
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 deviceDrug
Also called Treatments prescribed during regular clinical practice
Pressurized metered-dose inhalers (pMDIs), Breath-actuated pMDIs, Dry powder inhalers (DPIs), Nebulizers, Soft Mist Inhalers.
Regularly monitoring of the Inhalation technique through mobile appBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Inhaled Corticosteroids (ICs); Drug: Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA); Drug: Other treatments; Drug: Inhaler device; Behavioral: Regularly monitoring of the Inhalation technique through mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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)
Adherence is assessed separately for each controller inhaler, based on self-reported prescription start date, daily dosage recommendations and 3 questions on controller use over increasing time periods (day before, previous week, and previous month). Percentages of medication used versus prescribed are calculated first for each question, and subsequently as composite scores (0-100). The total score is categorized into complete (100%), intermediate, and low (50%) adherence. Medication abuse (temporary occasional) is also evaluated for each treatment.
Measured: 2, 5, 7 and 10 years after inclusion
Change from baseline in quality of the inhaler technique, measured with the Inhalation Technique Scale
The Inhalation Technique Scale includes five questions on how often participants perform recommended actions when using inhalers, on a 5-point Likert scale from 0 (never) to 4 (always). The overall score, calculated as the mean of items responses, ranges from 0 to 4 points. Higher values indicate better inhaler technique.
Measured: 2, 5, 7 and 10 years after downloading the ARCA app
Change from baseline in the Pediatric Asthma Impact Scale (PAIS)
The Patient-Reported Outcomes Measurement Information System (PROMIS) developed the short version of the Pediatric Asthma Impact Scale (PAIS), composed of 8 items assessing the past seven days in a 5-point response scale with the options: never, almost never, sometimes, often, and almost always. The total raw score (adding the values of the response to each question) is translated into a T-score with a mean of 50 and a standard deviation (SD) of 10. A score lower than 50 is one SD lower than the mean of the reference population.
Measured: 2, 5, 7 and 10 years after downloading the ARCA app
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start26 Jul 2017
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 525 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Montse Ferrer Fores, MD,PhD, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480242
- Sponsor's protocol ID
- ARCA2017
- Other IDs
- PI15/00449
- Acronym
- ARCA
- Status last verified
- May 2025
- First submitted
- 13 Jul 2020
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Children and Adolescents With Asthma: An Observational Prospective Study
- ClinicalTrials.gov ID
- NCT04480242
- Acronym / sponsor ID
- ARCA / ARCA2017
- Conditions
- Persistent Asthma, Asthma in Children, Asthma Exacerbation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Primary Objectives:
- To evaluate the asthma control in children and adolescents with persistent asthma, and its relationship with patient characteristics, treatment and health-related variables (treatment adherence, inhalation technique, inhaler device, asthma triggers, and smoking exposure, among others).
- To assess the health-related quality of life of children and adolescents with persistent asthma, and its relationship with patient characteristics, treatment and health-related variables (asthma control, treatment adherence and inhalation technique, inhaler device, asthma triggers, and smoking exposure, among others).
- To assess the risk of severe asthma exacerbations in children and adolescents with persistent asthma and its relationship with patient characteristics, treatment, and health-related variables (asthma control, treatment adherence and inhalation technique, inhaler device, health-related quality of life, asthma triggers, and smoking exposure, among others).
Secondary Objectives:
- To evaluate the effect of monitoring inhalation techniques on patients' performance according to recommended actions when using inhalers, and outcomes such as asthma control, health-related quality of life, and asthma exacerbations.
- To assess the treatment adherence in children and adolescents with persistent asthma, and its relationship with other treatment-related factors (inhaler technique, inhaler device, adherence attitudes, and beliefs about illness, inhaler and exacerbations, among others).
- To evaluate health inequalities in children and adolescents with asthma in Spain.
ARCA is a prospective multicenter observational study in children and adolescents with a clinical diagnosis of persistent asthma. This clinical diagnosis of asthma is defined as the presence of wheezing three times in the last year that improves with the use of bronchodilators. Participants are consecutively recruited in outpatient pediatric pulmonology hospital consultations and primary care physicians.
Patient-reported information is obtained by computer-assisted telephone interviews (CATI) and a mobile application (ARCA App). Telephone interviews are performed by trained interviewers to children 8-16 years old and parents/caregivers of children 6-7 years of age, immediately after recruitment and every 6 months. It includes the evaluation of asthma control, prescribed asthma treatment, adherence, and severe asthma exacerbations. Information about inhalation techniques, socioeconomic status, smoking exposure, triggers, use of peak flow, symptom diary, perceived asthma care, adherence attitudes, and beliefs about illness, inhaler and exacerbations is also collected.
The 'ARCA app' combines 3 age versions: parents/guardians (proxy response) for children 6-7 years old, children aged 8-11 years (self-response), and adolescents aged 12-16 years (self-response). The application consists in an interactive chat, simulating a conversation by Short Message Service (SMS) or Instant Messaging Application (WhatsApp) with someone in real time. It includes the monthly administration of 2 questions (global rating of change and severe asthma exacerbations). At the beginning, after downloading the app, and every two months different standardized questionnaires are administered by turns: the EuroQol (EQ-5D), the Pediatric Asthma Impact Scale (PAIS), inhalation techniques scale, and environment support. These latter scales are administered randomly to two groups of equal size, defined within the subsample recruited by each pediatrician.
All the information that each participant answers through the app can be viewed by the pediatrician through a specific platform. The results of the different questionnaires are shown in charts reflecting the patient's answers over time, using the traffic lights code: green for good outcomes, amber for intermediate, and red for poor. Clinical data is registered at recruitment and annually during the follow-up.
Sample size: To detect differences between two groups in the Asthma Control Questionnaire score of 0.3 SD, 175 patients per group would be required to have a statistical power of 80%, at a significance level of 5%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma Research in Children and Adolescents - Spanish Cohort | – | Drug: Inhaled Corticosteroids (ICs), Drug: Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA), Drug: Other treatments, Drug: Inhaler device, Behavioral: Regularly monitoring of the Inhalation technique through mobile appGroups defined according to treatments prescribed during regular clinical practice and to the exposure to inhalation techniques monitoring |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Spanish children and adolescents with persistent asthma seen in the outpatient pediatric pulmonology clinics and primary care pediatricians.
Key inclusion criteria (4 listed)
- 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').
Key exclusion criteria (8 listed)
- Concomitant respiratory diseases:
- Chronic obstructive pulmonary disease
- Cystic fibrosis
- Pulmonary fibrosis
- Bronchiectasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled Corticosteroids (ICs)Also: Treatments prescribed during regular clinical practiceAny 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 | Asthma Research in Children and Adolescents - Spanish Cohort |
| Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA)Also: Treatments prescribed during regular clinical practiceBeclomethasone/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 | Asthma Research in Children and Adolescents - Spanish Cohort |
| Other treatmentsAlso: Treatments prescribed during regular clinical practiceLow-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 | Asthma Research in Children and Adolescents - Spanish Cohort |
| Inhaler deviceAlso: Treatments prescribed during regular clinical practicePressurized metered-dose inhalers (pMDIs), Breath-actuated pMDIs, Dry powder inhalers (DPIs), Nebulizers, Soft Mist Inhalers. | Drug | Asthma Research in Children and Adolescents - Spanish Cohort |
| Regularly monitoring of the Inhalation technique through mobile appApp 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). | Behavioural | Asthma Research in Children and Adolescents - Spanish Cohort |
Primary outcome
Change from baseline in symptoms control, measured with the Asthma Control Questionnaire (ACQ)
Time frame: 2, 5, 7 and 10 years after inclusion
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.
Change from baseline in Health-Related Quality of Life, measured with the EuroQol
Time frame: 2, 5, 7 and 10 years after downloading the ARCA app
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).
Number of severe asthmatic exacerbations
Time frame: 5 and 10 years after inclusion
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.
3 secondary outcomes
Change from baseline in adherence to the treatment, measured with the Medication Intake Survey adherence scale-Asthma (MIS-A)
Time frame: 2, 5, 7 and 10 years after inclusion
Change from baseline in quality of the inhaler technique, measured with the Inhalation Technique Scale
Time frame: 2, 5, 7 and 10 years after downloading the ARCA app
Change from baseline in the Pediatric Asthma Impact Scale (PAIS)
Time frame: 2, 5, 7 and 10 years after downloading the ARCA app
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Recruitment platformLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montse Ferrer Fores, MD,PhD principal investigator
Parc de Salut Mar
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Asthma and Asthma in Children, run by Parc de Salut Mar at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in symptoms control, measured with the Asthma Control Questionnaire (ACQ) (time frame: 2, 5, 7 and 10 years after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.