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

NCT06966271 | Recruiting

• 1 other identifier: NNGYK/GYSZ/36422-4/2024
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 7

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.

Conditions

Asthma Bronchiale; COPD

Keywords

inhalation therapy; computer modelling; aerosol drug delivery

Outcome Measures

Primary Outcomes (1)

• 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.

  01.01.2025 - 30.07.2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tradeflex Ltd: lead
• Medisol Development Kft.: collaborator

Study Sites (7)

Országos Korányi Pulmonológiai Intézet

Budapest, Hungary

NOT YET RECRUITING

Csornai Margit Kórház Pulmonológiai és Allergológia Szakambulancia

Csorna, Hungary

NOT YET RECRUITING

Debreceni Egyetem Tüdőgyógyászati Klinika

Debrecen, Hungary

NOT YET RECRUITING

Dunakeszi-SZTK Nonprofit Kft. Tüdőgyógyászat

Dunakeszi, Hungary

NOT YET RECRUITING

Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

Győr, Hungary

NOT YET RECRUITING

• Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Tüdőgyógyászati Klinika

Szeged, Hungary

NOT YET RECRUITING

Református Pulmonológiai Centrum

Törökbálint, Hungary

RECRUITING

Related Publications (1)

• Horvath A, Farkas A, Szipocs A, Tomisa G, Szalai Z, Galffy G. Numerical simulation of the effect of inhalation parameters, gender, age and disease severity on the lung deposition of dry powder aerosol drugs emitted by Turbuhaler(R), Breezhaler(R) and Genuair(R) in COPD patients. Eur J Pharm Sci. 2020 Nov 1;154:105508. doi: 10.1016/j.ejps.2020.105508. Epub 2020 Aug 21.

  PMID: 32836137 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• János Varga, Prof.

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: January 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

HU (7)