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Completed

NCT Number: NCT05445349

Breathing Parameter Measurements for Lung Deposition Simulation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Debrecen, Debrecen, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Device

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.

Primary outcomes

  1. Lung deposition fraction

    Time frame: July 1, 2023 - June 30, 2025

    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.

Secondary outcomes

  1. Inhalation time

    Time frame: August 1, 2022 - June 30, 2023

    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.

  2. Peak inhalation flow

    Time frame: August 1, 2022 - June 30, 2023

    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.

  3. Inhaled volume

    Time frame: August 1, 2022 - June 30, 2023

    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.

  4. Ramp-up time

    Time frame: August 1, 2022 - June 30, 2023

    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.

  5. Breath-hold time

    Time frame: August 1, 2022 - June 30, 2023

    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.

Sponsors and collaborators

Lead sponsor

Medisol Development Kft.

Industry

Collaborators

  • Hospital of Komló
  • Medical Centre Hungarian Defence Forces
  • Pest County Pulmonology Hospital
  • St. Borbala Hospital
  • St. Pantaleon Hospital in Dunaújváros
  • University of Debrecen

Registry information

Official study 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

Acronym: CHOICE

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 6, 2022
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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