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

NCT07183657 | Recruiting

• 1 other identifier: NW25-09-00434
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Bronchial Asthma

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Intervention; Mobile Application; Bronchial asthma; Adherence; Inhaled therapy

Outcome Measures

Primary Outcomes (4)

• Adherence to inhaled treatment measured by Five Steps Assessment (FSA).

  Assessment of adherence to inhaled treatment measured by patients' behavior towards inhaled treatment and a number of mistakes in inhalation technique.

  Assessment of adherence to inhaled treatment within 12 months.

• Adherence to inhaled treatment measured by the Medication Adherence Report Scale (MARS).

  Assessment of adherence to inhaled treatment measured by patients' behavior towards inhaled treatment and a number of mistakes in inhalation technique.

  Assessment of adherence to inhaled treatment within 12 months.

• Critical knowledge measured by our own questionnaire in healthcare professionals caring for patients with COPD and bronchial asthma.

  Assessment of Critical knowledge by questions on correct usage of particular inhalation systems related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma.

  Critical knowledge related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma within 12 months

• Critical skills related to inhalation techniques measured by FSA in healthcare professionals caring for patients with COPD and bronchial asthma.

  Assessment of critical skills measured by a number of mistakes in inhalation technique in particular inhalation systems related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma.

  Critical skills related to inhalation techniques in healthcare professionals caring for patients with COPD and bronchial asthma within 12 months.

Secondary Outcomes (1)

• Assessment of clinical (e.g. CAT in patients with COPD) and laboratory (e.g. white blood cell count) biomarkers potentially indicating the stability of COPD and bronchial asthma in a subgroup of patients.

  Assessment of clinical and laboratory biomarkers potentially indicating the stability of COPD and bronchial asthma within 12 months.

Study Arms (1)

All project participants

OTHER

Education of inhalation technique

Other: Education in inhalation technique

Interventions

Education in inhalation technique OTHER

Education in inhalation technique

All project participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consent,
• age ≥ 18 years,
• previously diagnosed BA/COPD meeting GOLD 2024 and GINA 2024 diagnostic criteria,
• ability to cooperate,
• at least 8 weeks without exacerbation,
• use of a particular inhaler for at least 3 months.

You may not qualify if:

• pre-terminal/terminal stage of any disease,
• uncooperative patient,
• significant limitation of mobility or cognitive functions.
• HEALTHCARE PROFESSIONALS
• signed informed consent,
• completed education in medicine, pharmacy, or nursing,
• more than one year of working experience,
• care for patients taking inhaled therapy for BA/COPD.

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Ministry of Health, Czech Republic: collaborator
• University Hospital Hradec Kralove: collaborator
• University of Hradec Hralove: collaborator

Study Sites (1)

University Hospital Hradec Králové

Hradec Králové, 500 05, Czechia

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Josef Malý, Assoc. Prof. PhD.

CONTACT

00420 495 067 421; malyj@faf.cuni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: September 19, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-07

Locations

CZ (1)