NCT06966271 Investigation of the Respiratory Profile of Patients With Obstructive Pulmonary Disease (ASTHMA, COPD)
| NCT ID | NCT06966271 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tradeflex Ltd |
| Condition | Asthma Bronchiale |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-01-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
János Varga, Prof.
PRINCIPAL INVESTIGATOR
Semmelweis University
Frequently Asked Questions
Who can join the NCT06966271 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Asthma Bronchiale. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06966271 currently recruiting?
Yes, NCT06966271 is actively recruiting participants. Visit ClinicalTrials.gov or contact Tradeflex Ltd to inquire about joining.
Where is the NCT06966271 trial being conducted?
This trial is being conducted at Budapest, Hungary, Csorna, Hungary, Debrecen, Hungary, Dunakeszi, Hungary and 3 additional locations.
Who is sponsoring the NCT06966271 clinical trial?
NCT06966271 is sponsored by Tradeflex Ltd. The principal investigator is János Varga, Prof. at Semmelweis University. The trial plans to enroll 150 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.