RecruitingNot Applicable

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

Hungary150 participantsStarted 2025-01-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation of respiratory function with inhalation drug deposition deposition

Timeframe: 01.01.2025 - 30.07.2025

Trial details

NCT IDNCT06966271

SponsorTradeflex Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Asthma Bronchiale trials