NCT07145632 APP-based Medical Device for Education and Training of Inhalation Technique
| NCT ID | NCT07145632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Asthma (Part 1) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-06-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary aim: To investigate if app-based education and training of inhalation technique improves the rate of successful inhalation techniques compared with control group at 6-12 weeks follow-up visit. Secondary aims: To evaluate the feasibility, usability, and safety of the investigational during the study period. Study design: Two-armed, parallel-designed, individual single-blinded stratified randomisation by inhaler (DPI/MDI/both DPI and MDI) controlled trial with assignment (1:1) to (1) standard care and app-based education and training of inhalation technique or (2) standard education of inhalation technique over 6-12 weeks. Subjects: Subjects from the age of 16 years with documented diagnosis of asthma and/or COPD, daily treated with dry powder inhaler (DPI) or metered dose inhaler (MDI), or both, will be invited to voluntarily participate. Exclusion criteria is age \<16 years, no access to use BankID or similar electronic personal identification service, not using smartphone of type Android or iPhone, plan to stop use DPI and/or MDI the following 6-12 weeks from inclusion. No able to independently handle and inhale through DPI or MDI device. Total sample size: Eighty subjects (females and males) with daily treatment for COPD or asthma will be sufficient, based on the assumption of 25% percentage improvement in success rate of correct inhalation technique in the interventional group compared with control group (75% versus 50%) with 80% power at 5% significance level, including dropouts at 6-12 weeks follow-up visit. Intervention: At the baseline visit patients will be randomised to app-based intervention consisting of education and training of inhalation technique of all inhalers used on daily basis (the inhalation app-module). Stratified randomisation based on type of inhaler(s); MDI, DPI or both MDI and DPI will be applied. The intervention is the inhalation app-module, which is a medical device that is embedded the AsthmaTuner app. The AsthmaTuner app is a CE-marked cloud-based system (MDR Class 2b), provided by MediTuner AB, Stockholm, Sweden. The intervention group will be instructed to use the inhalation app-module on daily basis to improve their inhalation technique. Control group: Standard education of inhalation technique using list of standardised criteria and non-app-based education of inhaler technique. Endpoints: Primary endpoint is the rate of subjects with successful inhalation techniques based on subjective critical endpoints (CIP Table 2) and the following objective endpoints at the 6-12 weeks follow up visit: * DPI: PIF \> 30 L/Min, time to PIF \<0.5 seconds measured with the investigational device. * MDI: inspiration time (\> 3 seconds) and PIF less than 60 L/Min measured with the investigational device. Procedures: At baseline, a trained respiratory nurse will subjectively assess and train each patient's inhalation technique according to defined criteria of device handling (standard education). The AsthmaTuner app is downloaded to a smartphone or tablet computer (Ipad) that is wirelessly (Bluetooth) connected to a home spirometer. In this study the Bluetooth spirometer AsthmaTuner from MIR will be used. Education and training of inhalation technique will include measurement of inhalation flow with an adjustable resistance mounted on the spirometer, Airflow Trainer (MIR). The app gives instruction to set the resistance, so it corresponds to the selected inhaler. Questionnaires and interviews will collect information about the feasibility, safety and experienced usability of the investigational device. Analysis: The rate of subjects with successful inhalation technique at 6-12-week visit determined by fulfilling objective and subjective critical endpoints in intention-to-treat approach. The effect of using the inhalation app-module will be analysed with logistic regression analysis across randomisation groups. The secondary analysis of feasibility and the experienced benefit of using the inhalation app-module in clinical practice and for patient's education and training of inhalation technique is estimated on a Likert scale from 1 (not at all) to 5 (strongly agree) and presented as mean and median scores.
Eligibility Criteria
Inclusion Criteria: * Subjects at age \>16 years * Willing to voluntarily participate in the study and give electronic written informed consent * Prescribed with daily inhalation therapy through DPI and/or MDI for doctor's diagnosed asthma or COPD. Exclusion Criteria: * Age \<16 years, * No access to smartphone of type Android or iPhone * No access to electronic signature for informed consent * Plan to withdraw inhaler treatment including daily DPI and/or MDI the following 6-12 weeks. * Medical condition affecting the ability to independently inhale or use DPI or MDI device(s).
Frequently Asked Questions
Who can join the NCT07145632 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Asthma (Part 1). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07145632 currently recruiting?
Yes, NCT07145632 is actively recruiting participants. Visit ClinicalTrials.gov or contact Karolinska Institutet to inquire about joining.
Where is the NCT07145632 trial being conducted?
This trial is being conducted at Uppsala, Sweden, Styrsö, Sweden, Boxholm, Sweden.
Who is sponsoring the NCT07145632 clinical trial?
NCT07145632 is sponsored by Karolinska Institutet. The trial plans to enroll 80 participants.
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