Breathing Parameter Measurements for Lung Deposition Simulation (CHOICE)

Medisol Development

Status: Completed

Conditions: Asthma; COPD

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05445349

IV/657- 3 /2022/EKU (Registry Identifier)

OGYÉI/74-1/2022 (Registry Identifier)

TBEP-2110/01 (2021 V2)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

163 participants in 2 patient groups

Asthma patients

Description:

Patients with proven record of asthma disease.

Treatment:

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

COPD patients

Description:

Patients with proven record of COPD disease.

Treatment:

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