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NCT06966271Recruiting

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

Investigation of the Relationship Between the Respiratory Profile of Patients With Obstructive Pulmonary Disease and the Effectiveness of the Inhalation Therapies

Source: ClinicalTrials.gov · Last updated 11 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
2 May 2025
Start date
1 Jan 2025
Primary completion date
30 Sept 2025
Lead sponsor
Tradeflex Ltd
Diseases
Asthma, COPD
NCT number
NCT06966271

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 1 Jan 2025 to the primary completion date, 30 Sept 2025
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Failure to meet any of the inclusion criteria.
  • Presence of untreated severe chronic illness.

Other

  • Inability to complete the relevant parts of the questionnaire.
  • Refusal to consent to participation.
  • Invalid or improperly conducted pulmonary function test.

Who the study is looking for

  • 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.

Criteria the registry did not label

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Orszagos Koranyi Pulmonologiai Intezet
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BudapestHungaryNot yet recruiting
Csornai Margit Kórház Pulmonológiai és Allergológia Szakambulancia
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CsornaHungaryNot yet recruiting
Debreceni Egyetem Tüdőgyógyászati Klinika
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DebrecenHungaryNot yet recruiting
Dunakeszi-SZTK Nonprofit Kft. Tüdőgyógyászat
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DunakesziHungaryNot yet recruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryNot yet recruiting
• Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Tüdőgyógyászati Klinika
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SzegedHungaryNot yet recruiting
Református Pulmonológiai Centrum
Coordinator of this site? Confirm its status
TörökbálintHungaryRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.