CompletedNot Applicable

Breathing Parameter Measurements for Lung Deposition Simulation

Hungary163 participantsStarted 2022-09-01

Plain-language summary

This study aims to simulate the deposition of aerosol drugs within the airways of asthma and COPD patients based on realistic breathing patterns measured at different pulmonology centers. Further goal of the study is to find correlations between the amount of drug depositing in the lungs and the measured breathing parameters, as well as disease status and demographic data. The results of the study will be part of a major objective targeting the optimization and personalization of aerosol drug therapy.

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.

Inclusion Criteria: * diagnosed obstructive lung disease (asthma or COPD) * proper usage of inhalation tool after being educated * availability of whole body plethysmography measurement data from the last 6 months or the possibility to perform them before the start of the study * subject under outpatient/inpatient therapy * capable of acting and cooperating Exclusion Criteria: * the patient doesn't align with any of the criteria mentioned above * the patient is incapable of filling out the questionnaire/questionnaires' parts that are accorded to him/her * the patient doesn't agree to have data collected of him/her * diagnosed heavy, not treated chronic illness * not properly carried out /not evaluable lung function (spirometry) examination

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

Lung deposition fraction

Timeframe: July 1, 2023 - June 30, 2025

Trial details

NCT IDNCT05445349

SponsorMedisol Development Kft.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Asthma trials