Breathing Parameter Measurements for Lung Deposition Simulation

NCT05445349 | Completed

• 3 other identifiers: TBEP-2110/01 (2021 V2)OGYÉI/74-1/2022IV/657- 3 /2022/EKU
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 3

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.

Conditions

Asthma; COPD

Keywords

aerosol drug delivery; drug delivery optimization; inhalation therapy; breathing patterns; lung deposition modelling

Outcome Measures

Primary Outcomes (1)

• 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.

  July 1, 2023 - June 30, 2025

Secondary Outcomes (5)

• Inhalation time

  August 1, 2022 - June 30, 2023

• Peak inhalation flow

  August 1, 2022 - June 30, 2023

• Inhaled volume

  August 1, 2022 - June 30, 2023

• Ramp-up time

  August 1, 2022 - June 30, 2023

• Breath-hold time

  August 1, 2022 - June 30, 2023

Study Arms (2)

Asthma patients

Patients with proven record of asthma disease.

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

COPD patients

Patients with proven record of COPD disease.

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

Interventions

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.

Asthma patients; COPD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We are recruiting participants for our test from different levels of healthcare servicing (university centre, regional institute, county hospital, panel clinic) aiming to minimize centre specific effects.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medisol Development Kft.: lead
• Pest County Pulmonology Hospital: collaborator
• University of Debrecen: collaborator
• St. Borbala Hospital: collaborator
• Medical Centre Hungarian Defence Forces: collaborator
• Hospital of Komló: collaborator
• St. Pantaleon Hospital in Dunaújváros: collaborator

Study Sites (3)

University of Debrecen

Debrecen, Hungary

Location

St. Borbala Hospital

Tatabánya, Hungary

Location

Pest County Pulmonology Hospital

Törökbálint, 2045, Hungary

Location

Related Publications (12)

• Borgstrom L, Derom E, Stahl E, Wahlin-Boll E, Pauwels R. The inhalation device influences lung deposition and bronchodilating effect of terbutaline. Am J Respir Crit Care Med. 1996 May;153(5):1636-40. doi: 10.1164/ajrccm.153.5.8630614.

  PMID: 8630614 BACKGROUND

• Borghardt JM, Kloft C, Sharma A. Inhaled Therapy in Respiratory Disease: The Complex Interplay of Pulmonary Kinetic Processes. Can Respir J. 2018 Jun 19;2018:2732017. doi: 10.1155/2018/2732017. eCollection 2018.

  PMID: 30018677 BACKGROUND

• Busse WW, Brazinsky S, Jacobson K, Stricker W, Schmitt K, Vanden Burgt J, Donnell D, Hannon S, Colice GL. Efficacy response of inhaled beclomethasone dipropionate in asthma is proportional to dose and is improved by formulation with a new propellant. J Allergy Clin Immunol. 1999 Dec;104(6):1215-22. doi: 10.1016/s0091-6749(99)70016-3.

  PMID: 10589004 BACKGROUND

• Buttini F, Brambilla G, Copelli D, Sisti V, Balducci AG, Bettini R, Pasquali I. Effect of Flow Rate on In Vitro Aerodynamic Performance of NEXThaler((R)) in Comparison with Diskus((R)) and Turbohaler((R)) Dry Powder Inhalers. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):167-78. doi: 10.1089/jamp.2015.1220. Epub 2015 Sep 10.

  PMID: 26355743 BACKGROUND

• Corradi M, Chrystyn H, Cosio BG, Pirozynski M, Loukides S, Louis R, Spinola M, Usmani OS. NEXThaler, an innovative dry powder inhaler delivering an extrafine fixed combination of beclometasone and formoterol to treat large and small airways in asthma. Expert Opin Drug Deliv. 2014 Sep;11(9):1497-506. doi: 10.1517/17425247.2014.928282. Epub 2014 Jun 12.

  PMID: 24921434 BACKGROUND

• de Boer AH, Gjaltema D, Hagedoorn P, Frijlink HW. Can 'extrafine' dry powder aerosols improve lung deposition? Eur J Pharm Biopharm. 2015 Oct;96:143-51. doi: 10.1016/j.ejpb.2015.07.016. Epub 2015 Jul 26.

  PMID: 26220014 BACKGROUND

• Horvath A, Farkas A, Szipocs A, Tomisa G, Szalai Z, Galffy G. Numerical simulation of the effect of inhalation parameters, gender, age and disease severity on the lung deposition of dry powder aerosol drugs emitted by Turbuhaler(R), Breezhaler(R) and Genuair(R) in COPD patients. Eur J Pharm Sci. 2020 Nov 1;154:105508. doi: 10.1016/j.ejps.2020.105508. Epub 2020 Aug 21.

  PMID: 32836137 BACKGROUND

• Horvath A, Balashazy I, Tomisa G, Farkas A. Significance of breath-hold time in dry powder aerosol drug therapy of COPD patients. Eur J Pharm Sci. 2017 Jun 15;104:145-149. doi: 10.1016/j.ejps.2017.03.047. Epub 2017 Apr 4.

  PMID: 28389274 BACKGROUND

• Jokay A, Farkas A, Furi P, Horvath A, Tomisa G, Balashazy I. Computer modeling of airway deposition distribution of Foster((R)) NEXThaler((R)) and Seretide((R)) Diskus((R)) dry powder combination drugs. Eur J Pharm Sci. 2016 Jun 10;88:210-8. doi: 10.1016/j.ejps.2016.03.008. Epub 2016 Mar 11.

  PMID: 26976481 BACKGROUND

• Virchow JC, Poli G, Herpich C, Kietzig C, Ehlich H, Braeutigam D, Sommerer K, Haussermann S, Mariotti F. Lung Deposition of the Dry Powder Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Using NEXThaler(R) Device in Healthy Subjects, Asthmatic Patients, and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2018 Oct;31(5):269-280. doi: 10.1089/jamp.2016.1359. Epub 2018 Jul 10.

  PMID: 29989511 BACKGROUND

• Prime D, de Backer W, Hamilton M, Cahn A, Preece A, Kelleher D, Baines A, Moore A, Brealey N, Moynihan J. Effect of Disease Severity in Asthma and Chronic Obstructive Pulmonary Disease on Inhaler-Specific Inhalation Profiles Through the ELLIPTA(R) Dry Powder Inhaler. J Aerosol Med Pulm Drug Deliv. 2015 Dec;28(6):486-97. doi: 10.1089/jamp.2015.1224. Epub 2015 Sep 15.

  PMID: 26372467 BACKGROUND

• Hamilton M, Leggett R, Pang C, Charles S, Gillett B, Prime D. In Vitro Dosing Performance of the ELLIPTA(R) Dry Powder Inhaler Using Asthma and COPD Patient Inhalation Profiles Replicated with the Electronic Lung (eLung). J Aerosol Med Pulm Drug Deliv. 2015 Dec;28(6):498-506. doi: 10.1089/jamp.2015.1225. Epub 2015 Sep 15.

  PMID: 26372465 BACKGROUND

Related Links

• Global Initiative for asthma (GINA)
• Global Initiative for Chronic Obstructive Lung Disease (GOLD)

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriella Galffy, PhD

  Pest County Pulmonology Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 6, 2022
• Study Start: September 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Between months 9 and 36 after the publication of article(s).
• Access Criteria: IPD (individual patient data) will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. IPD will be shared to achieve aims in the approved proposal. Proposal may be submitted to farkasar@gmail.com.

Locations

HU (3)