Paediatric AsthmaALEXNCT07472283
Design, Development and Evaluation of a Digital Health Assistant for Paediatric Asthma
An observational study of Paediatric Asthma, run by University Children's Hospital Basel at 5 sites in Romania.
Trial summary
This study is to evaluate the efficacy of the digital health assistant (DHA) "Alex" in improving asthma control in asthmatic children and adolescents aged 10 to 19 compared to their baseline values. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Paediatric Asthma
- What is being tested?
- Phase I (months 1-3): DHA core functionality, Phase II (months 3-6): platform augmentation and Embedded qualitative study
- How many people
- 42 participants
- Where
- 5 sitesRomania
- Study dates
- Apr 2026to May 2027
- 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents, age 10 to 19 years, attending tertiary referral asthma clinics in the Romanian cities Brasov, Bucharest, Timisoara, and Suceava. For the Qualitative Substudy (IDIs and focus group discussions with adolescents), a sub-sample of participants from the observational study will be recruited, purposively selected to include roughly equal numbers of younger (10-14) and older (15-19) adolescents, as well as including both those that are identified as having higher and lower engagement, based on the app usage data.
Who may be able to join
- Written informed assent or consent, and parental/caregivers consent, depending on age.
- Age 10 to 19 years.
- Sufficient understanding of the Romanian language.
- Digital literacy, including the parents/caregivers, as assessed by the treating physician and/or by the recruiting healthcare provider using a multiple-choice questionnaire administered to the patient and their parents after a brief introduction to the functionalities of the Alex app.
- Confirmed asthma, i.e., history of recurrent wheeze, at least one spirometry in the three years prior to inclusion showing reversible obstruction (increase in forced expiratory volume at one second (FEV1) of ≥12% and/or ≥200ml) and/or a positive airway challenge test142.
- Participants need to be under treatment with regular prescribed asthma drugs, including inhaled corticosteroids, Long-acting β adrenoceptor agonists (LABA), and/or leukotriene receptor antagonists at recruitment, with no change in their medication in the last month.
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- Enrolled in the observational study
- Have had access to the DHA for at least 6 weeks
- Provide informed assent (and parental/guardian consent where applicable) or consent, according to age
- Able to participate in interviews or group discussions in Romanian
Who cannot join
- Inability to perform adequate lung function measurements due to physical and/or intellectual disability.
- Acute asthma exacerbation requiring systemic corticosteroids within four weeks prior to recruitment.
- Not willing to use smartphones.
- Underlying chronic respiratory disease other than asthma (cystic fibrosis, primary ciliary dyskinesia).
- Acute lower respiratory tract infections (e.g., pneumonia, bronchitis) diagnosed by physician within past 4 to 6 weeks. For tuberculosis, see next exclusion criterion.
- Active tuberculosis as per Quantiferon test.
Show all 12Show fewer
- Other causes of nocturnal cough such as postnasal drip, and vocal cord dysfunction.
- Active smoking as per urinary Cotinin test.
- Substance abuse as per urinary drug test.
- Qualitative study population:
- Significant cognitive or communication difficulties that would limit participation in interviews or group discussions
- Withdrawn from the observational study prior to data collection for qualitative work
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Romania5 sites
Theramed Healthcare and Transylvania University
Brasov
Ioana Agache
University Carol Davila and Componenta de Pediatrie - Institutul Național pentru Sănătatea Mamei și Copilului "Alessandrescu-Rusescu" București (INSMC)
Bucharest
Mihai Craiu
Spitalul Judetean De Urgenta
Suceava
Elena Tataranu
Pediatric Pulmonology Clinic, County Hospital, Victor Babes University of Medicine
Timișoara
Ioana Ciuca
Spitalul Clinic Judetean Timisoara and OncoGen Centre, Timisoara University of Medicine and Pharmacy Victor Babes
Timișoara
Carmen Bunu
About this study
This study is to evaluate the efficacy of the digital health assistant (DHA) "Alex" in improving asthma control in asthmatic children and adolescents aged 10 to 19 compared to their baseline values. It is designed to track over a period of six consecutive months lung function parameters, lung inflammation, asthma symptoms and burden, medication adherence, and passively recorded nocturnal asthma symptoms and markers related to sleep quality.
In Phase I (months 1-3), Digital Health Assistant (DHA) 's core functionality will be deployed.
Read more
In Phase II (months 3-6), the platform will be augmented with lung-function-fluctuations analysis-informed therapeutic recommendations, allowing to quantify the incremental benefit of targeted decision support beyond the gamified DHA alone.
An embedded qualitative study will be conducted to evaluate acceptability of and engagement with the DHA.
Read the detailed description
This cohort study is designed to track over a period of six consecutive months lung function parameters, lung inflammation, asthma symptoms and burden, medication adherence, and passively recorded nocturnal asthma symptoms and markers related to sleep quality. The study is comprised of two phases:
In Phase I (months 1-3), Digital Health Assistant (DHA) 's core functionality will be deployed, i.e., active collection of daily lung function, and fortnightly administration of the Asthma Control Questionnaire (ACQ), together with passive monitoring of controller asthma medication use and nocturnal physiological metrics (respiratory rate, SpO₂, heart rate, cough frequency) via inhaler sensor, smartwatch and bedside microphone. Moreover, Digital Health Assistant will act as an engagement/adherence enhancing patient coach, providing behavioral economics informed reminders and incentives, and educational materials on asthma and asthma treatment. This phase will enable to determine the effect of these core features of the Digital Health Assistant on asthma control.
In Phase II (months 3-6), the platform will be augmented with lung-function-fluctuations analysis-informed therapeutic recommendations, allowing to quantify the incremental benefit of targeted decision support beyond the gamified DHA alone.
In addition, an embedded qualitative study will be conducted to evaluate acceptability of and engagement with the DHA. This will include in-depth interviews (IDIs) with adolescents and focus group discussions (FGDs) with adolescents and healthcare providers.
- Conditions
- Paediatric Asthma
- Being tested
- Phase I (months 1-3): DHA core functionality, Phase II (months 3-6): platform augmentation, Embedded qualitative study
- Keywords
- Artificial Intelligence (AI), Chronic Obstructive Pulmonary Disease (COPD), Digital Health Assistant (DHA), Fractional Exhaled Nitric Oxide (FeNo), Arterial blood oxygen saturation (SpO2), In-depth Interview (IDI), Focus Group Discussion (FGD), Gamification, Digital health technologies, Asthma control
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I (months 1-3): DHA core functionalityOther
Active collection of daily lung function, and fortnightly administration of the Asthma Control Questionnaire (ACQ), together with passive monitoring of controller asthma medication use and nocturnal physiological metrics (respiratory rate, SpO₂, heart rate, cough frequency) via inhaler sensor, smartwatch and bedside microphone. Moreover, ALEX will act as an engagement/adherence enhancing patient coach, providing behavioral economics informed reminders and incentives, and educational materials on asthma and asthma treatment. This phase will enable to determine the effect of these core features of the DHA on asthma control.
Phase II (months 3-6): platform augmentationOther
Platform augmentation with lung-function-fluctuations analysis-informed therapeutic recommendations, allowing to quantify the incremental benefit of targeted decision support beyond the gamified DHA alone.
Embedded qualitative studyOther
An embedded qualitative study will be conducted to evaluate acceptability of and engagement with the DHA. This will include in-depth interviews (IDIs) with adolescents and focus group discussions (FGDs) with adolescents and healthcare providers.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Patients will be handed out and instructed on the use of the hardware (smartphone, portable spirometer, smartwatch, and usage sensor for personal controller medication inhaler). The smartphone application Alex will be preinstalled on the smartphones.Participants and their parents/caregivers will be interviewed at inclusion to decide on the preferred type of incentives for preventing disengagement with the tele-monitoring system. An embedded qualitative study will be conducted to evaluate acceptability of and engagement with the DHA. This will include in-depth interviews (IDIs) with adolescents and focus group discussions (FGDs) with adolescents and healthcare providers. Receives: Other: Phase I (months 1-3): DHA core functionality; Other: Phase II (months 3-6): platform augmentation; Other: Embedded qualitative study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the asthma control questionnaire (ACQ) score
The Asthma Control Questionnaire (ACQ) measures asthma control over the past week, with scores ranging from 0 (well-controlled) to 6 (extremely poorly controlled).
Measured: After 3 months relative to baseline (= Visit 2)
Secondary outcomes (8)
Change in the asthma control questionnaire (ACQ) score
The Asthma Control Questionnaire (ACQ) measures asthma control over the past week, with scores ranging from 0 (well-controlled) to 6 (extremely poorly controlled).
Measured: At Visit 2 (3 months after baseline), at Visit 3 (4.5 months after baseline),at Visit 4 (6 months after baseline)
Change in adherence to preventive inhaled corticosteroids
Adherence is defined as the proportion of preventer doses taken relative to the number of doses prescribed for a given time window.
Measured: At 1.5 months, 3 months, 4.5 months and 6 months after baseline
Number of days off school
Proportion of days off school for any reason with respect to the total number of available official school days since last visit (as reported by the patient and/or their parents/caregivers).
Measured: From Baseline to Visit 4 (6 months after baseline)
Number of unplanned attendances to general practitioner/emergency department for asthma
Number of unplanned attendances to general practitioner/emergency department for asthma. since last visit (as reported by the patient and/or their parents/caregivers).
Measured: From Baseline to Visit 4 (6 months after baseline)
Number of days of reliever (fast acting β-agonists) use
Number of days of reliever (fast acting β-agonists) use since last visit (as reported by the patient and/or their parents/caregivers).
Measured: From Baseline to Visit 4 (6 months after baseline)
Number of participants with one or more asthma exacerbations
Number of participants with one or more asthma exacerbations (as reported by the treating physician).
Measured: From Baseline to Visit 4 (6 months after baseline)
Absence from work the patient (as reported by the parents/caregivers).
Whether or not parents or caregivers were absent from work for one or more days since last visit due to health issues concerning the patient (as reported by the parents/caregivers).
Measured: From Baseline to Visit 4 (6 months after baseline)
Correlation between nocturnal breathing and nocturnal cough frequency measured passively using the smartphone and the smartwatch
Correlation between nocturnal breathing and nocturnal cough frequency measured passively using the smartphone and the smartwatch
Measured: From Baseline to Visit 4 (6 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Basel Research Center for Child Health
- Responsible party
- Sponsor
- Investigators
- Edgar Delgado-Eckert, Prof. Dr. med., Principal investigator, University Children's Hospital at University of Basel, Basel, SwitzerlandTorsten Schmitz Cherdron, Principal investigator, Swiss Tropical and Public Health Institute (Swiss TPH), Basel, SwitzerlandFilipe Da Conceicao Barata, Principal investigator, Center for Digital Health Interventions at ETH Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472283
- Sponsor's protocol ID
- ks25DelgadoEckert
- Acronym
- ALEX
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Development and Evaluation of a Digital Health Assistant for Paediatric Asthma
- ClinicalTrials.gov ID
- NCT07472283
- Acronym / sponsor ID
- ALEX / ks25DelgadoEckert
- Conditions
- Paediatric Asthma
- Keywords
- Artificial Intelligence (AI), Chronic Obstructive Pulmonary Disease (COPD), Digital Health Assistant (DHA), Fractional Exhaled Nitric Oxide (FeNo), Arterial blood oxygen saturation (SpO2), In-depth Interview (IDI), Focus Group Discussion (FGD), Gamification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Collaborators
- Basel Research Center for Child Health
- Study start
- Apr 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
This study is to evaluate the efficacy of the digital health assistant (DHA) "Alex" in improving asthma control in asthmatic children and adolescents aged 10 to 19 compared to their baseline values. It is designed to track over a period of six consecutive months lung function parameters, lung inflammation, asthma symptoms and burden, medication adherence, and passively recorded nocturnal asthma symptoms and markers related to sleep quality.
In Phase I (months 1-3), Digital Health Assistant (DHA) 's core functionality will be deployed.
In Phase II (months 3-6), the platform will be augmented with lung-function-fluctuations analysis-informed therapeutic recommendations, allowing to quantify the incremental benefit of targeted decision support beyond the gamified DHA alone.
An embedded qualitative study will be conducted to evaluate acceptability of and engagement with the DHA.
Detailed description
This cohort study is designed to track over a period of six consecutive months lung function parameters, lung inflammation, asthma symptoms and burden, medication adherence, and passively recorded nocturnal asthma symptoms and markers related to sleep quality. The study is comprised of two phases:
In Phase I (months 1-3), Digital Health Assistant (DHA) 's core functionality will be deployed, i.e., active collection of daily lung function, and fortnightly administration of the Asthma Control Questionnaire (ACQ), together with passive monitoring of controller asthma medication use and nocturnal physiological metrics (respiratory rate, SpO₂, heart rate, cough frequency) via inhaler sensor, smartwatch and bedside microphone. Moreover, Digital Health Assistant will act as an engagement/adherence enhancing patient coach, providing behavioral economics informed reminders and incentives, and educational materials on asthma and asthma treatment. This phase will enable to determine the effect of these core features of the Digital Health Assistant on asthma control.
In Phase II (months 3-6), the platform will be augmented with lung-function-fluctuations analysis-informed therapeutic recommendations, allowing to quantify the incremental benefit of targeted decision support beyond the gamified DHA alone.
In addition, an embedded qualitative study will be conducted to evaluate acceptability of and engagement with the DHA. This will include in-depth interviews (IDIs) with adolescents and focus group discussions (FGDs) with adolescents and healthcare providers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Phase I (months 1-3): DHA core functionality, Other: Phase II (months 3-6): platform augmentation, Other: Embedded qualitative studyPatients will be handed out and instructed on the use of the hardware (smartphone, portable spirometer, smartwatch, and usage sensor for personal controller medication inhaler). The smartphone application Alex will be preinstalled on the smartphones.Participants and their parents/caregivers will be interviewed at inclusion to decide on the preferred type of incentives for preventing disengagement with the tele-monitoring system. An embedded qualitative study will be conducted to evaluate acceptability of and engagement with the DHA. This will include in-depth interviews (IDIs) with adolescents and focus group discussions (FGDs) with adolescents and healthcare providers. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents, age 10 to 19 years, attending tertiary referral asthma clinics in the Romanian cities Brasov, Bucharest, Timisoara, and Suceava. For the Qualitative Substudy (IDIs and focus group discussions with adolescents), a sub-sample of participants from the observational study will be recruited, purposively selected to include roughly equal numbers of younger (10-14) and older (15-19) adolescents, as well as including both those that are identified as having higher and lower engagement, based on the app usage data.
Key inclusion criteria (10 listed)
- Written informed assent or consent, and parental/caregivers consent, depending on age.
- Age 10 to 19 years.
- Sufficient understanding of the Romanian language.
- Digital literacy, including the parents/caregivers, as assessed by the treating physician and/or by the recruiting healthcare provider using a multiple-choice questionnaire administered to the patient and their parents after a brief introduction to the functionalities of the Alex app.
- Confirmed asthma, i.e., history of recurrent wheeze, at least one spirometry in the three years prior to inclusion showing reversible obstruction (increase in forced expiratory volume at one second (FEV1) of ≥12% and/or ≥200ml) and/or a positive airway challenge test142.
Key exclusion criteria (12 listed)
- Inability to perform adequate lung function measurements due to physical and/or intellectual disability.
- Acute asthma exacerbation requiring systemic corticosteroids within four weeks prior to recruitment.
- Not willing to use smartphones.
- Underlying chronic respiratory disease other than asthma (cystic fibrosis, primary ciliary dyskinesia).
- Acute lower respiratory tract infections (e.g., pneumonia, bronchitis) diagnosed by physician within past 4 to 6 weeks. For tuberculosis, see next exclusion criterion.
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 |
|---|---|---|
| Phase I (months 1-3): DHA core functionalityActive collection of daily lung function, and fortnightly administration of the Asthma Control Questionnaire (ACQ), together with passive monitoring of controller asthma medication use and nocturnal physiological metrics (respiratory rate, SpO₂, heart rate, cough frequency) via inhaler sensor, smartwatch and bedside microphone. Moreover, ALEX will act as an engagement/adherence enhancing patient coach, providing behavioral economics informed reminders and incentives, and educational materials on asthma and asthma treatment. This phase will enable to determine the effect of these core features of the DHA on asthma control. | Other | Observational group |
| Phase II (months 3-6): platform augmentationPlatform augmentation with lung-function-fluctuations analysis-informed therapeutic recommendations, allowing to quantify the incremental benefit of targeted decision support beyond the gamified DHA alone. | Other | Observational group |
| Embedded qualitative studyAn embedded qualitative study will be conducted to evaluate acceptability of and engagement with the DHA. This will include in-depth interviews (IDIs) with adolescents and focus group discussions (FGDs) with adolescents and healthcare providers. | Other | Observational group |
Primary outcome
Change in the asthma control questionnaire (ACQ) score
Time frame: After 3 months relative to baseline (= Visit 2)
The Asthma Control Questionnaire (ACQ) measures asthma control over the past week, with scores ranging from 0 (well-controlled) to 6 (extremely poorly controlled).
8 secondary outcomes
Change in the asthma control questionnaire (ACQ) score
Time frame: At Visit 2 (3 months after baseline), at Visit 3 (4.5 months after baseline),at Visit 4 (6 months after baseline)
Change in adherence to preventive inhaled corticosteroids
Time frame: At 1.5 months, 3 months, 4.5 months and 6 months after baseline
Number of days off school
Time frame: From Baseline to Visit 4 (6 months after baseline)
Number of unplanned attendances to general practitioner/emergency department for asthma
Time frame: From Baseline to Visit 4 (6 months after baseline)
Number of days of reliever (fast acting β-agonists) use
Time frame: From Baseline to Visit 4 (6 months after baseline)
Number of participants with one or more asthma exacerbations
Time frame: From Baseline to Visit 4 (6 months after baseline)
Absence from work the patient (as reported by the parents/caregivers).
Time frame: From Baseline to Visit 4 (6 months after baseline)
Correlation between nocturnal breathing and nocturnal cough frequency measured passively using the smartphone and the smartwatch
Time frame: From Baseline to Visit 4 (6 months after baseline)
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 16 Mar 2026.
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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.
Edgar Delgado-Eckert, Prof. Dr. med. principal investigator
University Children's Hospital at University of Basel, Basel, Switzerland
Torsten Schmitz Cherdron principal investigator
Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland
Filipe Da Conceicao Barata principal investigator
Center for Digital Health Interventions at ETH Zurich, Zurich, Switzerland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatric Asthma, run by University Children's Hospital Basel at 5 sites in Romania.
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 10 inclusion and 12 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Romania. 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?
Contact Edgar Delgado-Eckert, Prof. Dr. med. (+41 61 704 18 37, Edgar.Delgado-Eckert@ukbb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the asthma control questionnaire (ACQ) score (time frame: After 3 months relative to baseline (= Visit 2)). 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 16 Mar 2026.