CHOICE: Breathing Parameter Measurements for Lung Deposition Simulation

Sponsor

Medisol Development Kft. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05445349

Collaborator

Pest County Pulmonology Hospital (Other), University of Debrecen (Other), St. Borbala Hospital (Other), Medical Centre Hungarian Defence Forces (Other), Hospital of Komló (Other), St. Pantaleon Hospital in Dunaújváros (Other)

200

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma COPD	Device: Emptied dry powder inhalers (DPI) used in routine asthma and COPD therapy

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Asthma patients Patients with proven record of asthma disease.	Device: Emptied dry powder inhalers (DPI) used in routine asthma and COPD therapy 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.
COPD patients Patients with proven record of COPD disease.	Device: Emptied dry powder inhalers (DPI) used in routine asthma and COPD therapy 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.

Arm

Intervention/Treatment

Asthma patients

Patients with proven record of asthma disease.

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

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.

COPD patients

Patients with proven record of COPD disease.

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

Outcome Measures

Primary Outcome Measures

Lung deposition fraction [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 Outcome Measures

Inhalation time [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.
Peak inhalation flow [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.
Inhaled volume [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.
Ramp-up time [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.
Breath-hold time [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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