Improving how adults with COPD and asthma stick to and use their inhalers
Adherence to Inhaled Therapy - a Globally Overlooked Problem in Patients With Chronic Obstructive Pulmonary Disease and Bronchial Asthma
This project will test whether a mobile/web app plus targeted training helps adults with COPD or asthma use their inhalers correctly and keep taking their inhaled medicines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Hradec Králové) |
| Trial ID | NCT07183657 on ClinicalTrials.gov |
What this trial studies
This is a multicenter prospective observation-interventional project enrolling about 800 outpatients and nursing home residents with COPD or bronchial asthma and 200 healthcare professionals. It uses a validated Five Steps Assessment tool plus artificial intelligence methods to develop, implement, and validate a mobile/web app for patients and clinicians. Interventions include training on inhalation technique, educational materials, telephone/online contact, e-learning for professionals, and repeated follow-up to measure change. The study will compare adherence and technique before and after the interventions across participating sites.
Who should consider this trial
Good fit: Adults (≥18) with physician-diagnosed COPD or bronchial asthma per GOLD/GINA, clinically stable for at least 8 weeks, who have used the same inhaler for ≥3 months and can cooperate and provide informed consent.
Not a fit: Patients in a pre-terminal stage, those with major cognitive or mobility impairments, or those unwilling or unable to use the app or participate in training are unlikely to benefit.
Why it matters
Potential benefit: If successful, patients could achieve better inhaler technique, improved symptom control, fewer exacerbations, and reduced healthcare visits.
How similar studies have performed: Previous inhaler training and digital reminder programs have produced modest improvements in technique and adherence, while combining the Five Steps Assessment with an AI-driven app represents a relatively new approach.
Eligibility criteria
Show full inclusion / exclusion criteria
PATIENTS Inclusion Criteria: 1. signed informed consent, 2. age ≥ 18 years, 3. previously diagnosed BA/COPD meeting GOLD 2024 and GINA 2024 diagnostic criteria, 4. ability to cooperate, 5. at least 8 weeks without exacerbation, 6. use of a particular inhaler for at least 3 months. Exclusion Criteria: 1. pre-terminal/terminal stage of any disease, 2. uncooperative patient, 3. significant limitation of mobility or cognitive functions. HEALTHCARE PROFESSIONALS Inclusion Criteria: 1. signed informed consent, 2. completed education in medicine, pharmacy, or nursing, 3. more than one year of working experience, 4. care for patients taking inhaled therapy for BA/COPD.
Where this trial is running
Hradec Králové
- University Hospital Hradec Králové — Hradec Králové, Czechia (Recruiting)
Study contacts
- Study coordinator: Josef Malý, Assoc. Prof. PhD.
- Email: malyj@faf.cuni.cz
- Phone: 00420 495 067 421
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.