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AsthmaCHOICENCT05445349

Breathing Parameter Measurements for Lung Deposition Simulation

An observational study of Asthma and COPD, run by Medisol Development Kft. at 3 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma, COPD
What is being tested?
Emptied dry powder inhalers (DPI) used in routine asthma and COPD therapy
Type of treatment
Medical device
How many people
163 participants
Where
3 sitesHungary
Study dates
1 Sep 2022to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

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: We are recruiting participants for our test from different levels of healthcare servicing (university centre, regional institute, county hospital, panel clinic) aiming to minimize centre specific effects.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Hungary3 sites

  • University of Debrecen

    Debrecen

  • St. Borbala Hospital

    Tatabánya

  • Pest County Pulmonology Hospital

    Törökbálint, 2045

Other trials in Hungary

About this study

Official title: Measurement of Breathing Parameters of Asthma and COPD Patients With Different Degrees of Disease Severity for the Computer Simulation of Lung Deposition of Aerosol Drugs

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.

Read the detailed description

The inhalation of aerosol drugs is a key element of current asthma and COPD treatment. The efficiency of the therapy is highly influenced by the dose depositing in the lungs. However, the amount of drug depositing in the lung is a result of complex drug particle-inhaler-patient interaction, thus it is inhaler-, drug- and patient-specific. Assuming that the airflow dependent aerodynamic characteristics of the drugs are known, the lung dose depends on the patient's breathing parameters during the inhalation of drug through the inhaler. In this study the inhalation parameters of asthmatic and COPD patients are measured and lung deposition assessed by a validated numerical lung deposition model. Effects of different breathing parameters (inhalation time, inhaled volume, average flow rate, peak flow rate, time until peak flow rate is reached, breath-hold time) as well as patient demographic data, disease type and disease severity on the lung dose are studied. The correlations are analysed for asthma and COPD groups separately.

Conditions
Asthma, COPD
Being tested
Emptied dry powder inhalers (DPI) used in routine asthma and COPD therapy
Keywords
aerosol drug delivery, drug delivery optimization, inhalation therapy, breathing patterns, lung deposition modelling
Medical subject headings
Asthma, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emptied dry powder inhalers (DPI) used in routine asthma and COPD therapyDevice

    The DPI inhaler devices are empty, without any active ingredient or/and carrier substances. Patients are not inhaling drug doses because of the study. They are inhaling only the type and quantity of aerosol drugs that they would inhale because of their treatment. The study does not influences the undergoing treatment by medication in any way.

Study groups in NCT05445349
Study groupRoleWhat they receive
Asthma patientsPatients with proven record of asthma disease.
Receives: Device: Emptied dry powder inhalers (DPI) used in routine asthma and COPD therapy
COPD patientsPatients with proven record of COPD disease.
Receives: Device: Emptied dry powder inhalers (DPI) used in routine asthma and COPD therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lung deposition fraction

    Lung deposition fraction is the ratio of the drug dose depositing in the lungs to the dose available in the device. Lung dose will be evaluated by means of computer modelling based on input data (breathing parameters) measured in this study.

    Measured: July 1, 2023 - June 30, 2025

Secondary outcomes (5)

  1. Inhalation time

    Inhalation time is measured while patients inhale through the empty inhalers mimicking the inhalation of aerosol drug. It expresses the duration of the inhalation in seconds.

    Measured: August 1, 2022 - June 30, 2023

  2. Peak inhalation flow

    Peak inhalation flow is measured while patients inhale through the empty inhalers mimicking the inhalation of aerosol drug. It expresses the maximum value of the flow rate expressed in Liter/min.

    Measured: August 1, 2022 - June 30, 2023

  3. Inhaled volume

    Inhaled volume is measured while patients inhale through the empty inhalers mimicking the inhalation of aerosol drug. It expresses the quantity of inhaled air expressed in Liter.

    Measured: August 1, 2022 - June 30, 2023

  4. Ramp-up time

    Ramp-up time is determined from the inhalation curve measured while patients inhale through the empty inhalers mimicking the inhalation of aerosol drug. It expresses the time duration from the beginning of inhalation to the moment when the inhalation flow rate reaches its maximum value.

    Measured: August 1, 2022 - June 30, 2023

  5. Breath-hold time

    Breath-hold time is measured by the investigator and expresses the duration in seconds from the end of inhalation through the device until the beginning of exhalation.

    Measured: August 1, 2022 - June 30, 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start1 Sep 2022
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2025

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05445349
Sponsor's protocol ID
TBEP-2110/01 (2021 V2)
Other IDs
OGYÉI/74-1/2022, IV/657- 3 /2022/EKU
Acronym
CHOICE
Status last verified
Nov 2025
First submitted
27 Jun 2022
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: The data sharing plan contains statements on the availability of individual participant data (including data dictionaries), information on what data in particular will be shared, what other documents will be available, when will data be available, with whom, for what type of analyses. In addition, the plan specifies the mechanism the data are be made available. According to the plan those IPD will be available that underlie the results published in research article(s) will be shared after deidentification. The frame of IPD sharing is defined below:

Publications

  • Borgstrom L, Derom E, Stahl E, Wahlin-Boll E, Pauwels R. The inhalation device influences lung deposition and bronchodilating effect of terbutaline. Am J Respir Crit Care Med. 1996 May;153(5):1636-40. doi: 10.1164/ajrccm.153.5.8630614.

    PubMed 8630614

  • Borghardt JM, Kloft C, Sharma A. Inhaled Therapy in Respiratory Disease: The Complex Interplay of Pulmonary Kinetic Processes. Can Respir J. 2018 Jun 19;2018:2732017. doi: 10.1155/2018/2732017. eCollection 2018.

    PubMed 30018677

  • Busse WW, Brazinsky S, Jacobson K, Stricker W, Schmitt K, Vanden Burgt J, Donnell D, Hannon S, Colice GL. Efficacy response of inhaled beclomethasone dipropionate in asthma is proportional to dose and is improved by formulation with a new propellant. J Allergy Clin Immunol. 1999 Dec;104(6):1215-22. doi: 10.1016/s0091-6749(99)70016-3.

    PubMed 10589004

  • Buttini F, Brambilla G, Copelli D, Sisti V, Balducci AG, Bettini R, Pasquali I. Effect of Flow Rate on In Vitro Aerodynamic Performance of NEXThaler((R)) in Comparison with Diskus((R)) and Turbohaler((R)) Dry Powder Inhalers. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):167-78. doi: 10.1089/jamp.2015.1220. Epub 2015 Sep 10.

    PubMed 26355743

  • Corradi M, Chrystyn H, Cosio BG, Pirozynski M, Loukides S, Louis R, Spinola M, Usmani OS. NEXThaler, an innovative dry powder inhaler delivering an extrafine fixed combination of beclometasone and formoterol to treat large and small airways in asthma. Expert Opin Drug Deliv. 2014 Sep;11(9):1497-506. doi: 10.1517/17425247.2014.928282. Epub 2014 Jun 12.

    PubMed 24921434

  • de Boer AH, Gjaltema D, Hagedoorn P, Frijlink HW. Can 'extrafine' dry powder aerosols improve lung deposition? Eur J Pharm Biopharm. 2015 Oct;96:143-51. doi: 10.1016/j.ejpb.2015.07.016. Epub 2015 Jul 26.

    PubMed 26220014

  • 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

  • Horvath A, Balashazy I, Tomisa G, Farkas A. Significance of breath-hold time in dry powder aerosol drug therapy of COPD patients. Eur J Pharm Sci. 2017 Jun 15;104:145-149. doi: 10.1016/j.ejps.2017.03.047. Epub 2017 Apr 4.

    PubMed 28389274

  • Jokay A, Farkas A, Furi P, Horvath A, Tomisa G, Balashazy I. Computer modeling of airway deposition distribution of Foster((R)) NEXThaler((R)) and Seretide((R)) Diskus((R)) dry powder combination drugs. Eur J Pharm Sci. 2016 Jun 10;88:210-8. doi: 10.1016/j.ejps.2016.03.008. Epub 2016 Mar 11.

    PubMed 26976481

  • Virchow JC, Poli G, Herpich C, Kietzig C, Ehlich H, Braeutigam D, Sommerer K, Haussermann S, Mariotti F. Lung Deposition of the Dry Powder Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Using NEXThaler(R) Device in Healthy Subjects, Asthmatic Patients, and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2018 Oct;31(5):269-280. doi: 10.1089/jamp.2016.1359. Epub 2018 Jul 10.

    PubMed 29989511

  • Prime D, de Backer W, Hamilton M, Cahn A, Preece A, Kelleher D, Baines A, Moore A, Brealey N, Moynihan J. Effect of Disease Severity in Asthma and Chronic Obstructive Pulmonary Disease on Inhaler-Specific Inhalation Profiles Through the ELLIPTA(R) Dry Powder Inhaler. J Aerosol Med Pulm Drug Deliv. 2015 Dec;28(6):486-97. doi: 10.1089/jamp.2015.1224. Epub 2015 Sep 15.

    PubMed 26372467

  • Hamilton M, Leggett R, Pang C, Charles S, Gillett B, Prime D. In Vitro Dosing Performance of the ELLIPTA(R) Dry Powder Inhaler Using Asthma and COPD Patient Inhalation Profiles Replicated with the Electronic Lung (eLung). J Aerosol Med Pulm Drug Deliv. 2015 Dec;28(6):498-506. doi: 10.1089/jamp.2015.1225. Epub 2015 Sep 15.

    PubMed 26372465

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and COPD, run by Medisol Development Kft. at 3 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 5 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: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung deposition fraction (time frame: July 1, 2023 - June 30, 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 NCT05445349, which also lists 12 linked publications.

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 28 Nov 2025.

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