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| ID | Type | Description | Link |
|---|---|---|---|
| OGYÉI/74-1/2022 | Registry Identifier | National Institute of Pharmacy and Nutrition | |
| IV/657- 3 /2022/EKU | Registry Identifier | Medical Research Council |
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| Name | Class |
|---|---|
| Pest County Pulmonology Hospital | UNKNOWN |
| University of Debrecen | OTHER |
| St. Borbala Hospital | OTHER_GOV |
| Medical Centre Hungarian Defence Forces |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma patients | Patients with proven record of asthma disease. |
| |
| COPD patients | Patients with proven record of COPD disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Peak inhalation flow |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Gabriella Galffy, PhD | Pest County Pulmonology Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Debrecen | Debrecen | Hungary | ||||
| St. Borbala Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8630614 | Background | 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. | |
| 30018677 | 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. |
| Label | URL |
|---|---|
| Global Initiative for asthma (GINA) | View source |
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The data sharing plan contains statements on the availability of individual participant data (including data dictionaries), information on what data in particular will be shared, what other documents will be available, when will data be available, with whom, for what type of analyses. In addition, the plan specifies the mechanism the data are be made available.
According to the plan those IPD will be available that underlie the results published in research article(s) will be shared after deidentification.
The frame of IPD sharing is defined below:
Between months 9 and 36 after the publication of article(s).
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2022 | Jun 24, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2022 | Jun 26, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| UNKNOWN |
| Hospital of Komló | UNKNOWN |
| St. Pantaleon Hospital in Dunaújváros | UNKNOWN |
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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 |
| 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 |
| 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 |
| 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 |
| Tatabánya |
| Hungary |
| Pest County Pulmonology Hospital | Törökbálint | 2045 | Hungary |
| 10589004 | 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. |
| 26355743 | 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. |
| 24921434 | 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. |
| 26220014 | 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. |
| 32836137 | 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. |
| 28389274 | 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. |
| 26976481 | 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. |
| 29989511 | 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. |
| 26372467 | 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. |
| 26372465 | 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. |
| Global Initiative for Chronic Obstructive Lung Disease (GOLD) | View source |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |