Asthma BronchialeOPTIPULMNCT06966271
Investigation of the Respiratory Profile of Patients With Obstructive Pulmonary Disease (ASTHMA, COPD)
An observational study of Asthma Bronchiale and COPD, run by Tradeflex Ltd at 7 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Bronchiale, COPD
- How many people
- 150 participants
- Where
- 7 sitesHungary
- Study dates
- 1 Jan 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Hungary7 sites, 7 recruiting
- Not yet recruiting
Országos Korányi Pulmonológiai Intézet
Budapest
- Not yet recruiting
Csornai Margit Kórház Pulmonológiai és Allergológia Szakambulancia
Csorna
- Not yet recruiting
Debreceni Egyetem Tüdőgyógyászati Klinika
Debrecen
- Not yet recruiting
Dunakeszi-SZTK Nonprofit Kft. Tüdőgyógyászat
Dunakeszi
- Not yet recruiting
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr
- Not yet recruiting
• Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Tüdőgyógyászati Klinika
Szeged
- Recruiting
Református Pulmonológiai Centrum
Törökbálint
Alpár Horváth, MD, +36302363122, horvath65881@gmai.com
About this study
Official title: Investigation of the Relationship Between the Respiratory Profile of Patients With Obstructive Pulmonary Disease and the Effectiveness of the Inhalation Therapies
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.
Read more
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.
Read the detailed description
Study Title:
Assessment of the Relationship Between Inhalation Therapy Effectiveness and Breathing Profiles in Patients with Obstructive Pulmonary Diseases (OPTIPULM)
The primary goal of this observational cross-sectional study is to analyze the relationship between patients' breathing characteristics and the effectiveness of their inhaled therapies. The study targets adult patients diagnosed with asthma or chronic obstructive pulmonary disease (COPD).
Background and Rationale:
Asthma and COPD are chronic obstructive airway diseases with increasing prevalence worldwide. Despite the availability of a wide range of inhaled medications and delivery devices, therapy is often suboptimal due to patient-specific factors such as improper inhalation technique or mismatch between inhaler resistance and the patient's inspiratory capacity.
Emerging data suggest that aerosol deposition in the lungs-and therefore the efficacy of treatment-can be significantly influenced by the individual's breathing profile and the inhalation device used. However, this is rarely taken into account in routine clinical practice.
Study Objectives:
Primary Objective:
To evaluate individual pulmonary function test (PFT) data and, based on this, to model and estimate drug deposition in the lungs using computer simulation for various inhaler-drug combinations.
Secondary Objectives:
To assess the inhalation techniques of patients.
To recommend device optimization strategies based on flow-resistance matching.
To identify which device (among commercially available options) is most likely to deliver the highest lung deposition for the individual patient.
- Conditions
- Asthma Bronchiale, COPD
- Keywords
- inhalation therapy, computer modelling, aerosol drug delivery
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 01.01.2025 - 30.07.2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jan 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma BronchialeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tradeflex Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medisol Development Kft.
- Responsible party
- Sponsor
- Investigators
- János Varga, Prof., Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966271
- Sponsor's protocol ID
- NNGYK/GYSZ/36422-4/2024
- Acronym
- OPTIPULM
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32836137
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between the Respiratory Profile of Patients With Obstructive Pulmonary Disease and the Effectiveness of the Inhalation Therapies
- ClinicalTrials.gov ID
- NCT06966271
- Acronym / sponsor ID
- OPTIPULM / NNGYK/GYSZ/36422-4/2024
- Conditions
- Asthma Bronchiale, COPD
- Keywords
- inhalation therapy, computer modelling, aerosol drug delivery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tradeflex LtdIndustry (pharma, biotech, devices)
- Collaborators
- Medisol Development Kft.
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Title:
Assessment of the Relationship Between Inhalation Therapy Effectiveness and Breathing Profiles in Patients with Obstructive Pulmonary Diseases (OPTIPULM)
The primary goal of this observational cross-sectional study is to analyze the relationship between patients' breathing characteristics and the effectiveness of their inhaled therapies. The study targets adult patients diagnosed with asthma or chronic obstructive pulmonary disease (COPD).
Background and Rationale:
Asthma and COPD are chronic obstructive airway diseases with increasing prevalence worldwide. Despite the availability of a wide range of inhaled medications and delivery devices, therapy is often suboptimal due to patient-specific factors such as improper inhalation technique or mismatch between inhaler resistance and the patient's inspiratory capacity.
Emerging data suggest that aerosol deposition in the lungs-and therefore the efficacy of treatment-can be significantly influenced by the individual's breathing profile and the inhalation device used. However, this is rarely taken into account in routine clinical practice.
Study Objectives:
Primary Objective:
To evaluate individual pulmonary function test (PFT) data and, based on this, to model and estimate drug deposition in the lungs using computer simulation for various inhaler-drug combinations.
Secondary Objectives:
To assess the inhalation techniques of patients.
To recommend device optimization strategies based on flow-resistance matching.
To identify which device (among commercially available options) is most likely to deliver the highest lung deposition for the individual patient.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of respiratory function with inhalation drug deposition deposition
Time frame: 01.01.2025 - 30.07.2025
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Results publication: PubMed 32836137Horvath 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
János Varga, Prof. principal investigator
Semmelweis University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Bronchiale and COPD, run by Tradeflex Ltd at 7 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of respiratory function with inhalation drug deposition deposition (time frame: 01.01.2025 - 30.07.2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06966271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.