Breathing Parameter Measurements for Lung Deposition Simulation

Asthma Clinical Trial

— CHOICE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05445349
• Other study ID #: TBEP-2110/01 (2021 V2)
• Secondary ID: OGYÉI/74-1/2022I
• Status: Active, not recruiting
• Start date: September 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Medisol Development Kft.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 163
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

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.

Locations

Country	Name	City	State
Hungary	University of Debrecen	Debrecen
Hungary	St. Borbala Hospital	Tatabánya
Hungary	Pest County Pulmonology Hospital	Törökbálint

Sponsors (7)

Lead Sponsor	Collaborator
Medisol Development Kft.	Hospital of Komló, Medical Centre Hungarian Defence Forces, Pest County Pulmonology Hospital, St. Borbala Hospital, St. Pantaleon Hospital in Dunaújváros, University of Debrecen

Country where clinical trial is conducted

Hungary, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Expert Opin Drug Deliv. 2014 Nov;11(11):1827. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	August 1, 2022 - June 30, 2023
Secondary	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.	August 1, 2022 - June 30, 2023
Secondary	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.	August 1, 2022 - June 30, 2023
Secondary	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.	August 1, 2022 - June 30, 2023
Secondary	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.	August 1, 2022 - June 30, 2023

External Links

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