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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTradeflex Ltd

About this trial

The primary aim of the OPTIPULM study is the evaluation of recorded pulmonary function curves and, based on them, the computer modelling of lung deposition for the individually used or potentially applicable inhalation drugs. The secondary aims include assessing the patients' inhalation device usage and providing recommendations for its optimization based on the recorded breathing curves and deposition calculations. The study also compares results across different flow rates and device resistances, aiming to identify the device with the highest modelled lung deposition for each patient.

Understanding and Improving Inhalation Therapy in Lung Disease The OPTIPULM study looks at how well inhaled medications reach the lungs of people living with asthma or COPD (chronic obstructive pulmonary disease). It aims to improve treatment by helping doctors choose the best inhaler for each patient based on how they breathe.

Every patient breathes differently, and not all inhalers work the same way. Sometimes the medicine doesn't reach deep enough into the lungs, which can make treatment less effective. This study helps doctors better understand which device works best for each individual.

What happens during the study? No new treatments or changes to medication are made.

Patients do a regular breathing test (like blowing into a tube). A computer program uses this breathing data to simulate how much medicine reaches the lungs with different inhalers.

Doctors can then make more personalized choices for inhalation therapy.

Who can take part? Adults with asthma or COPD who are able to use their inhaler correctly and complete a breathing test.

What is the benefit? Although the study does not change treatments directly, it helps improve future care by identifying the best-matching inhaler for each patient. This can lead to better symptom control and fewer exacerbations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population includes adult outpatients (≥18 years old) diagnosed with obstructive airway diseases, specifically asthma or chronic obstructive pulmonary disease (COPD). Patients must be under the care of a pulmonologist and capable of performing a routine pulmonary function test (spirometry). Participants are required to demonstrate the correct use of their prescribed inhaler following brief education and instruction. The population may include a range of disease severities (mild to severe) and treatment regimens, reflecting real-world inhaler usage. Both male and female participants are eligible, with no restriction on ethnicity or socioeconomic status. Participants must be mentally competent and able to provide informed consent.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Correlation of respiratory function with inhalation drug deposition deposition

The aims of the study are to evaluate the recorded respiratory function (spirometry), and on this basis, computer modelling of the lung deposition of inhalation drugs and selection of personalised therapy.

Time frame
01.01.2025 - 30.07.2025

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tradeflex Ltd

Lead sponsor

Medisol Development Kft.

Collaborator