Investigation of the Respiratory Profile of Patients With Obstructive Pulmonary Disease (ASTHMA, COPD)

Study Title:

Assessment of the Relationship Between Inhalation Therapy Effectiveness and Breathing Profiles in Patients with Obstructive Pulmonary Diseases (OPTIPULM)

The primary goal of this observational cross-sectional study is to analyze the relationship between patients' breathing characteristics and the effectiveness of their inhaled therapies. The study targets adult patients diagnosed with asthma or chronic obstructive pulmonary disease (COPD).

Background and Rationale:

Asthma and COPD are chronic obstructive airway diseases with increasing prevalence worldwide. Despite the availability of a wide range of inhaled medications and delivery devices, therapy is often suboptimal due to patient-specific factors such as improper inhalation technique or mismatch between inhaler resistance and the patient's inspiratory capacity.

Emerging data suggest that aerosol deposition in the lungs-and therefore the efficacy of treatment-can be significantly influenced by the individual's breathing profile and the inhalation device used. However, this is rarely taken into account in routine clinical practice.

Study Objectives:

Primary Objective:

To evaluate individual pulmonary function test (PFT) data and, based on this, to model and estimate drug deposition in the lungs using computer simulation for various inhaler-drug combinations.

Secondary Objectives:

To assess the inhalation techniques of patients.

To recommend device optimization strategies based on flow-resistance matching.

To identify which device (among commercially available options) is most likely to deliver the highest lung deposition for the individual patient.

Primary Outcome Measure:

Estimated Lung Deposition of Inhaled Medication (% of Emitted Dose): The proportion of the inhaled drug dose predicted to deposit in the lungs, calculated via computer modeling using each participant's individual pulmonary function curve and inhalation parameters.

Inclusion criteria

• Diagnosed obstructive pulmonary disease (asthma or COPD) confirmed by a pulmonologist.
• Proper use of inhalation device after training.
• Routine pulmonary function test performed during medical visit.
• Ambulatory (non-hospitalized) patient.
• Age over 18 years.
• Mentally competent and able to consent.

Exclusion criteria

• Failure to meet any of the inclusion criteria.
• Inability to complete the relevant parts of the questionnaire.
• Refusal to consent to participation.
• Presence of untreated severe chronic illness.
• Invalid or improperly conducted pulmonary function test.