Breathing Parameter Measurements for Lung Deposition Simulation

Active, not recruiting

• Conditions: Asthma; COPD

• Registration Number: NCT05445349
• Lead Sponsor: Medisol Development Kft.

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.

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 Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-06
• Study Start: 2022-09-01
• Primary Completion: 2024-06-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (3)

University of Debrecen; 🇭🇺 Debrecen, Hungary

St. Borbala Hospital; 🇭🇺 Tatabánya, Hungary

Pest County Pulmonology Hospital; 🇭🇺 Törökbálint, Hungary