NCT07183657

Adherence to Inhaled Therapy - a Globally Overlooked Problem in Patients With Chronic Obstructive Pulmonary Disease and Bronchial Asthma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comprehensive assessment and interventions to promote adherence to inhaled therapy in patients with bronchial asthma and chronic obstructive pulmonary disease involving health care professionals caring for these patients in different settings and using the Five Steps Assessment tool and artificial intelligence methods and tools.

Detailed description

Nonadherence to inhaled therapy is a significant problem in patients with bronchial asthma (BA) and chronic obstructive pulmonary disease (COPD), which has a negative impact on the patients´ health as well as increases the healthcare system costs. The present project focuses on multimodal assessment of adherence to inhaled therapy in patients with BA and COPD and knowledge and skills related to inhalation technique in healthcare professionals caring for patients with BA and COPD at different levels of care using our simple and validated Five Steps Assessment (FSA) tool. This is a multicenter prospective observation-interventional study planning to include 800 outpatients treated in health care facilities and nursing home residents and 200 health care professionals. During the project, a mobile/web-based app using artificial intelligence applicable to patients and healthcare professionals will be developed, implemented, and validated. Interventions (e.g., training on correct inhalation technique, educational materials, telephone/online contact, mobile/web app) to promote adherence to inhaled therapy in BA and COPD will be developed and implemented in patients. In the case of healthcare professionals, interventions (e.g., course including e-learning, mobile/web app) will be directed at increasing knowledge and skills related to inhalation technique. The impact of the interventions on patients and healthcare professionals will be verified by repeated follow-up. To be able to assess the improvement in adherence to inhaled therapy in depth, clinical and laboratory biomarkers potentially indicating the stability of COPD and BA will be measured. The outputs of the project may help to identify patients with given diagnoses at high risk of medication nonadherence and to offer simple, effective, and widely available interventions to promote medication adherence as well as to educate healthcare professionals and thereby to improve patient care.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)
• Bronchial Asthma

Interventions

Type	Name	Description
OTHER	Education in inhalation technique	Education in inhalation technique

Timeline

• Start date: 2025-06-03
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2025-09-19
• Last updated: 2025-09-30

Locations

1 site across 1 country: Czechia