Severe AsthmaNCT07393984
Digital Self-Monitoring in Severe Asthma
A study testing AioCare home spirometry system in people with Severe Asthma and Asthma, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.
Trial summary
This randomized controlled pilot study aimed to assess adherence to telemedicine-based home monitoring using the AioCare digital respiratory system in adults with severe asthma over a three-month period and to determine whether weekly reminder messages sent via SMS or through the AioCare platform enhanced adherence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma, Asthma
- What is being tested?
- AioCare home spirometry system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRomania
- Study dates
- 1 Oct 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of severe asthma according to GINA guidelines.
- Age ≥ 18 years.
- Ability to correctly perform spirometry maneuvers according to ATS/ERS standards after training.
- Access to a smartphone compatible with the AioCare application.
- Willingness to participate in weekly home-based spirometry monitoring and telemonitoring for three months.
- Stable maintenance asthma therapy for at least four weeks prior to enrollment.
- Ability and willingness to provide written informed consent.
Who cannot join
- Age < 18 years.
- Diagnosis of other significant respiratory diseases (including chronic obstructive pulmonary disease, interstitial lung disease, or bronchiectasis).
- Asthma exacerbation requiring hospitalization or systemic corticosteroids within the four weeks prior to enrollment.
- Severe psychiatric or cognitive impairment that could interfere with adherence to the monitoring protocol or ability to use the device independently.
- Inability to perform acceptable spirometry maneuvers despite training.
- Lack of smartphone or internet access required for AioCare telemonitoring.
- Pregnancy or breastfeeding.
- Refusal or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Romania1 site
Dr. Victor Babeș Clinical Hospital for Infectious Diseases and Pulmonology, Timișoara
Timișoara, Timiș County, 300310
About this study
Official title: Effect of Digital Self-Monitoring on Patient Engagement and Clinical Outcomes in Severe Asthma: A Randomized Controlled Pilot Study
This randomized controlled pilot study aimed to assess adherence to telemedicine-based home monitoring using the AioCare digital respiratory system in adults with severe asthma over a three-month period and to determine whether weekly reminder messages sent via SMS or through the AioCare platform enhanced adherence compared with standard remote monitoring.
The study was conducted at a single center in Timișoara, Romania, between October 2024 and October 2025. Thirty adult patients with severe asthma were randomized 1:1 to either an intervention group receiving weekly reminders via SMS or in-app notifications, or a control group without reminders. All participants performed weekly home spirometry for 12 weeks using the AioCare system.
Read more
The primary objective of the study was to assess adherence to telemedicine-based home monitoring over the three-month period and to evaluate the effect of weekly reminder messages on adherence compared with standard remote monitoring.
The study found that patients who received reminder messages demonstrated higher adherence to home monitoring compared with those who did not receive reminders. No device-related adverse events were reported.
Read the detailed description
This study investigated telemedicine-based home monitoring in adults with severe asthma using the AioCare digital respiratory system in a real-world clinical setting.
Participants were equipped with a portable AioCare spirometry device and trained to use the associated mobile application for home measurements. The system enabled wireless transmission of spirometric data to a secure cloud-based platform, allowing remote review of patient-generated data by the study team.
After enrollment and training, patients performed regular home spirometry over a three-month monitoring period. Measurements were conducted in the patients' home environment and automatically uploaded through the AioCare platform. Data quality was assessed according to international acceptability and repeatability criteria.
One study group additionally received automated weekly reminder messages delivered via SMS or through the AioCare application, depending on technical availability and patient preference. These reminders were standardized and intended to support regular performance of home measurements. The comparator group used the same monitoring system without reminders.
Throughout the study, participants continued their usual standard-of-care treatment. No experimental medications or therapeutic interventions were introduced. Study procedures focused on remote data collection, monitoring feasibility, and patient interaction with the digital health system.
At the end of the monitoring period, patient-reported questionnaires were administered to document user experience with the telemonitoring system. Safety was monitored throughout the study, with specific attention to device-related adverse events.
- Conditions
- Severe Asthma, Asthma
- Being tested
- AioCare home spirometry system
- Keywords
- Severe asthma, Telemedicine, Digital health, Home spirometry, Adherence, Patient engagement, Reminders, eHealth
- Medical subject headings
- Asthma, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AioCare home spirometry systemDevice
The AioCare digital respiratory system was used to perform weekly home spirometry and to transmit lung function data to a secure telemedicine platform for remote monitoring by the study team.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Reminder) | Experimental | Adults with severe asthma who used the AioCare digital respiratory system for home spirometry and received weekly reminder messages via SMS or in-app notifications to support adherence. Receives: Device: AioCare home spirometry system |
| Control group | Active comparator | Adults with severe asthma who used the AioCare digital respiratory system for home spirometry without receiving reminder messages (standard remote monitoring). Receives: Device: AioCare home spirometry system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to telemedicine-based home monitoring
Proportion of prescribed weekly home spirometry sessions successfully completed and transmitted via the AioCare system during the 12-week monitoring period.
Measured: 12 weeks
Asthma control assessed by ACT
Change in Asthma Control Test (ACT) score from baseline to week 12. The ACT is a validated 5-item questionnaire, with scores ranging from 5 to 25, where higher scores indicate better asthma control. Scores ≥20 indicate well-controlled asthma, 16-19 partially controlled, and ≤15 poorly controlled. A change of ≥3 points is considered clinically meaningful.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Oct 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a single-center, randomized, parallel-group pilot study. Participants were randomized in a 1:1 ratio to either an intervention group receiving weekly reminder messages via SMS or via the AioCare platform, or to a control group receiving standard telemedicine-based home monitoring without reminders.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norbert Wellmann, University of Medicine and Pharmacy "Victor Babes" Timisoara
- Investigators
- Norbert Wellmann, MD, Phd student, Principal investigator, Victor Babes Hospital for Infectious and Pulmonary Diseases, Timisoara, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393984
- Sponsor's protocol ID
- AIOCARE-SEV-ASTHMA
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digital Self-Monitoring on Patient Engagement and Clinical Outcomes in Severe Asthma: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07393984
- Acronym / sponsor ID
- AIOCARE-SEV-ASTHMA
- Conditions
- Severe Asthma, Asthma
- Keywords
- Severe asthma, Telemedicine, Digital health, Home spirometry, Adherence, Patient engagement, Reminders, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" TimisoaraUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 6 Feb 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 randomized controlled pilot study aimed to assess adherence to telemedicine-based home monitoring using the AioCare digital respiratory system in adults with severe asthma over a three-month period and to determine whether weekly reminder messages sent via SMS or through the AioCare platform enhanced adherence compared with standard remote monitoring.
The study was conducted at a single center in Timișoara, Romania, between October 2024 and October 2025. Thirty adult patients with severe asthma were randomized 1:1 to either an intervention group receiving weekly reminders via SMS or in-app notifications, or a control group without reminders. All participants performed weekly home spirometry for 12 weeks using the AioCare system.
The primary objective of the study was to assess adherence to telemedicine-based home monitoring over the three-month period and to evaluate the effect of weekly reminder messages on adherence compared with standard remote monitoring.
The study found that patients who received reminder messages demonstrated higher adherence to home monitoring compared with those who did not receive reminders. No device-related adverse events were reported.
Detailed description
This study investigated telemedicine-based home monitoring in adults with severe asthma using the AioCare digital respiratory system in a real-world clinical setting.
Participants were equipped with a portable AioCare spirometry device and trained to use the associated mobile application for home measurements. The system enabled wireless transmission of spirometric data to a secure cloud-based platform, allowing remote review of patient-generated data by the study team.
After enrollment and training, patients performed regular home spirometry over a three-month monitoring period. Measurements were conducted in the patients' home environment and automatically uploaded through the AioCare platform. Data quality was assessed according to international acceptability and repeatability criteria.
One study group additionally received automated weekly reminder messages delivered via SMS or through the AioCare application, depending on technical availability and patient preference. These reminders were standardized and intended to support regular performance of home measurements. The comparator group used the same monitoring system without reminders.
Throughout the study, participants continued their usual standard-of-care treatment. No experimental medications or therapeutic interventions were introduced. Study procedures focused on remote data collection, monitoring feasibility, and patient interaction with the digital health system.
At the end of the monitoring period, patient-reported questionnaires were administered to document user experience with the telemonitoring system. Safety was monitored throughout the study, with specific attention to device-related adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a single-center, randomized, parallel-group pilot study. Participants were randomized in a 1:1 ratio to either an intervention group receiving weekly reminder messages via SMS or via the AioCare platform, or to a control group receiving standard telemedicine-based home monitoring without reminders.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Reminder) | Experimental | Device: AioCare home spirometry systemAdults with severe asthma who used the AioCare digital respiratory system for home spirometry and received weekly reminder messages via SMS or in-app notifications to support adherence. |
| Control group | Active comparator | Device: AioCare home spirometry systemAdults with severe asthma who used the AioCare digital respiratory system for home spirometry without receiving reminder messages (standard remote monitoring). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of severe asthma according to GINA guidelines.
- Age ≥ 18 years.
- Ability to correctly perform spirometry maneuvers according to ATS/ERS standards after training.
- Access to a smartphone compatible with the AioCare application.
- Willingness to participate in weekly home-based spirometry monitoring and telemonitoring for three months.
Key exclusion criteria (8 listed)
- Age < 18 years.
- Diagnosis of other significant respiratory diseases (including chronic obstructive pulmonary disease, interstitial lung disease, or bronchiectasis).
- Asthma exacerbation requiring hospitalization or systemic corticosteroids within the four weeks prior to enrollment.
- Severe psychiatric or cognitive impairment that could interfere with adherence to the monitoring protocol or ability to use the device independently.
- Inability to perform acceptable spirometry maneuvers despite training.
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 |
|---|---|---|
| AioCare home spirometry systemThe AioCare digital respiratory system was used to perform weekly home spirometry and to transmit lung function data to a secure telemedicine platform for remote monitoring by the study team. | Device | Control group, Intervention group (Reminder) |
Primary outcome
Adherence to telemedicine-based home monitoring
Time frame: 12 weeks
Proportion of prescribed weekly home spirometry sessions successfully completed and transmitted via the AioCare system during the 12-week monitoring period.
Asthma control assessed by ACT
Time frame: Baseline and 12 weeks
Change in Asthma Control Test (ACT) score from baseline to week 12. The ACT is a validated 5-item questionnaire, with scores ranging from 5 to 25, where higher scores indicate better asthma control. Scores ≥20 indicate well-controlled asthma, 16-19 partially controlled, and ≤15 poorly controlled. A change of ≥3 points is considered clinically meaningful.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Norbert Wellmann, MD, Phd student principal investigator
Victor Babes Hospital for Infectious and Pulmonary Diseases, Timisoara, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AioCare home spirometry system in people with Severe Asthma and Asthma, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site 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 7 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: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence to telemedicine-based home monitoring (time frame: 12 weeks). The study lists 2 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 6 Feb 2026.