Can a smart app tame childhood asthma?
NCT ID NCT07472283
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a digital health assistant called 'Alex' to help children and teens aged 10 to 19 with asthma. Over six months, the app tracks lung function, symptoms, and medication use, and later gives personalized advice. The goal is to see if it improves asthma control and makes it easier for kids to manage their condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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10 to 19 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Observational study population: Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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: Inclusion criteria: * 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 Exclusion criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Pediatric Pulmonology Clinic, County Hospital, Victor Babes University of Medicine
Timișoara, Romania
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Spitalul Clinic Judetean Timisoara and OncoGen Centre, Timisoara University of Medicine and Pharmacy Victor Babes
Timișoara, Romania
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Spitalul Judetean De Urgenta
Suceava, Romania
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Theramed Healthcare and Transylvania University
Brasov, Romania
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University Carol Davila and Componenta de Pediatrie - Institutul Național pentru Sănătatea Mamei și Copilului "Alessandrescu-Rusescu" București (INSMC)
Bucharest, Romania
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