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 volunteersQualifiers
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
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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Tradeflex Ltd
Lead sponsor
Medisol Development Kft.
Collaborator