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.
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.
Study Type
OBSERVATIONAL
Enrollment
163
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.
University of Debrecen
Debrecen, Hungary
St. Borbala Hospital
Tatabánya, Hungary
Pest County Pulmonology Hospital
Törökbálint, Hungary
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.
Time frame: July 1, 2023 - June 30, 2025
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.
Time frame: August 1, 2022 - June 30, 2023
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.
Time frame: August 1, 2022 - June 30, 2023
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.
Time frame: August 1, 2022 - June 30, 2023
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.
Time frame: August 1, 2022 - June 30, 2023
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.
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Time frame: August 1, 2022 - June 30, 2023