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The goal of this clinical trial is to determine if triple inhaled therapy with Budesonide/Glycopyrronium/Formoterol (BGF) and Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.
The main questions it aims to answer are:
This study is a randomized crossover study. COPD patients aged 40 years or older with stable disease are included. Each patient receives four weeks of treatment with either BGF or FUV followed by a one-week washout period, and then four weeks of treatment with the other drug. Respiratory symptoms are assessed using modified Medical Research Council (mMRC) dyspnea scale and COPD Assessment Test (CAT). Pulmonary function is assessed by spirometry with bronchodilator testing, and adverse events were recorded. Spirometry data, including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and forced expiratory flow at 25-75% of FVC (FEF25-75) are also collected. Impulse oscillometry (IOS) is also performed, with results reported as R5, R20, R5-R20, X5, Fres, and Ax.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide/Glycopyrronium/Formoterol (BGF) | Experimental | BGF (160/7.2/5 mcg) 2 inhalations, twice daily for 4 weeks |
|
| Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) | Active Comparator | FUV (100/62.5/25 mcg) 1 inhalation, once daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/Glycopyrronium/Formoterol (BGF) | Drug | Each patient received 4 weeks of treatment with either BGF or FUV followed by a 1-week washout period, and then 4 weeks of treatment with the other drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in airway resistance at 5 Hz (R5) on COPD patients | Changes in R5 assessed by impulse oscillometry (IOS), reported as kPa/L/s and percent predicted value. | From enrollment to the end of treatment at 8 weeks |
| Changes in airway resistance at 20 Hz (R20) on COPD patients | Changes in R20 assessed by impulse oscillometry (IOS), reported as kPa/L/s and percent predicted value. | From enrollment to the end of treatment at 8 weeks |
| Difference of airway resistance between 5 Hz and 20 Hz (R5-R20) on COPD patients | Changes in R5-R20 assessed by impulse oscillometry (IOS), reported as kPa/L/s. | From enrollment to the end of treatment at 8 weeks |
| Reactance at 5 Hz (X5) on COPD patients | Changes in X5 assessed by impulse oscillometry (IOS), reported as kPa/L/s. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in forced expiratory volume in 1 second (FEV1) in COPD patients | Changes in FEV1 assessed by spirometry, reported as liter (L) and percent predicted value. | From enrollment to the end of treatment at 8 weeks |
| Changes in forced vital capacity (FVC) in COPD patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narongkorn Saiphoklang, MD | Thammasat University Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Narongkorn Saiphoklang | Pathum Thani | Changwat Pathum Thani | 12120 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37742015 | Result | Usmani O, Li G, De Backer J, Sadafi H, Wu L, Marshall J. Modeled small airways lung deposition of two fixed-dose triple therapy combinations assessed with in silico functional respiratory imaging. Respir Res. 2023 Sep 23;24(1):226. doi: 10.1186/s12931-023-02534-y. | |
| 33116458 | Result | Usmani OS, Scichilone N, Mignot B, Belmans D, Van Holsbeke C, De Backer J, De Maria R, Cuoghi E, Topole E, Georges G. Airway Deposition of Extrafine Inhaled Triple Therapy in Patients with COPD: A Model Approach Based on Functional Respiratory Imaging Computer Simulations. Int J Chron Obstruct Pulmon Dis. 2020 Oct 7;15:2433-2440. doi: 10.2147/COPD.S269001. eCollection 2020. |
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IPD and documents will be available for sharing immediately after publication for a period of 2 years.
IPD and documents will be available for sharing immediately after publication for a period of 2 years.
All researchers will be able to access the IPD and supporting information via the repository website without restriction.
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This study is a randomized crossover study. COPD patients aged 40 years or older with stable disease are included. Each patient receives four weeks of treatment with either BGF or FUV followed by a one-week washout period, and then four weeks of treatment with the other drug. Respiratory symptoms, pulmonary function, and safety are assessed.
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|
| Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) | Drug | Each patient received 4 weeks of treatment with either BGF or FUV followed by a 1-week washout period, and then 4 weeks of treatment with the other drug. |
|
|
Changes in FVC assessed by spirometry, reported as liter (L) and percent predicted value. |
| From enrollment to the end of treatment at 8 weeks |
| Changes in FEV1/FVC ratio in COPD patients | Changes in FEV1/FVC ratio assessed by spirometry, reported as percent. | From enrollment to the end of treatment at 8 weeks |
| Changes in forced expiratory flow at 25-75% of FVC (FEF25-75) in COPD patients | Changes in FEF25-75 assessed by spirometry, reported as liter/second (L/s) and percent predicted value. | From enrollment to the end of treatment at 8 weeks |
| Changes in modified Medical Research Council dyspnea scale in COPD patients | Changes in this dyspnea scale are reported in points, with a minimum range of 0 and a maximum of 5. Higher scores indicate more symptoms. | From enrollment to the end of treatment at 8 weeks |
| Changes in COPD assessment test score in COPD patients | Changes in this score are reported in points, with a minimum range of 0 and a maximum of 40. Higher scores indicate more symptoms. | From enrollment to the end of treatment at 8 weeks |
| 29370819 | Result | Bremner PR, Birk R, Brealey N, Ismaila AS, Zhu CQ, Lipson DA. Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study. Respir Res. 2018 Jan 25;19(1):19. doi: 10.1186/s12931-018-0724-0. |
| 34035312 | Result | Bansal S, Anderson M, Anzueto A, Brown N, Compton C, Corbridge TC, Erb D, Harvey C, Kaisermann MC, Kaye M, Lipson DA, Martin N, Zhu CQ, Papi A. Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD. NPJ Prim Care Respir Med. 2021 May 25;31(1):29. doi: 10.1038/s41533-021-00241-z. |
| 28375647 | Result | Lipson DA, Barnacle H, Birk R, Brealey N, Locantore N, Lomas DA, Ludwig-Sengpiel A, Mohindra R, Tabberer M, Zhu CQ, Pascoe SJ. FULFIL Trial: Once-Daily Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Aug 15;196(4):438-446. doi: 10.1164/rccm.201703-0449OC. |
| 39458663 | Result | Maneechotesuwan K, Sawatdee S, Srichana T. In Vitro Analysis of Aerodynamic Properties and Co-Deposition of a Fixed-Dose Combination of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate. Pharmaceutics. 2024 Oct 18;16(10):1334. doi: 10.3390/pharmaceutics16101334. |
| 34171789 | Result | Martinez FJ, Rabe KF, Ferguson GT, Wedzicha JA, Trivedi R, Jenkins M, Darken P, Aurivillius M, Dorinsky P. Benefits of budesonide/glycopyrrolate/formoterol fumarate (BGF) on symptoms and quality of life in patients with COPD in the ETHOS trial. Respir Med. 2021 Aug-Sep;185:106509. doi: 10.1016/j.rmed.2021.106509. Epub 2021 Jun 18. |
| 32103926 | Result | Ishiura Y, Fujimura M, Ohkura N, Hara J, Kasahara K, Ishii N, Sawai Y, Shimizu T, Tamaki T, Nomura S. Triple Therapy with Budesonide/Glycopyrrolate/Formoterol Fumarate Improves Inspiratory Capacity in Patients with Asthma-Chronic Obstructive Pulmonary Disease Overlap. Int J Chron Obstruct Pulmon Dis. 2020 Feb 5;15:269-277. doi: 10.2147/COPD.S231004. eCollection 2020. |
| 34428980 | Result | Rabe KF, Martinez FJ, Singh D, Trivedi R, Jenkins M, Darken P, Aurivillius M, Dorinsky P. Improvements in lung function with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler versus dual therapies in patients with COPD: a sub-study of the ETHOS trial. Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211034329. doi: 10.1177/17534666211034329. |
| 30232048 | Result | Ferguson GT, Rabe KF, Martinez FJ, Fabbri LM, Wang C, Ichinose M, Bourne E, Ballal S, Darken P, DeAngelis K, Aurivillius M, Dorinsky P, Reisner C. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):747-758. doi: 10.1016/S2213-2600(18)30327-8. Epub 2018 Sep 16. |
| 34620167 | Result | Usmani O, Roche N, Wahab E, Israel S, Jenkins M, Trivedi R, Dorinsky P, Aurivillius M. A scintigraphy study of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2021 Oct 7;22(1):261. doi: 10.1186/s12931-021-01813-w. |
| 25180727 | Result | Bickel S, Popler J, Lesnick B, Eid N. Impulse oscillometry: interpretation and practical applications. Chest. 2014 Sep;146(3):841-847. doi: 10.1378/chest.13-1875. |
| 26557240 | Result | McNulty W, Usmani OS. Techniques of assessing small airways dysfunction. Eur Clin Respir J. 2014 Oct 17;1. doi: 10.3402/ecrj.v1.25898. eCollection 2014. |
| 39046133 | Result | Lazarinis N, Fouka E, Linden A, Bossios A. Small airways disease in chronic obstructive pulmonary disease. Expert Rev Respir Med. 2024 Jul;18(7):539-552. doi: 10.1080/17476348.2024.2380070. Epub 2024 Jul 24. |
| 31688242 | Result | Singh D, Long G, Cancado JED, Higham A. Small airway disease in chronic obstructive pulmonary disease: insights and implications for the clinician. Curr Opin Pulm Med. 2020 Mar;26(2):162-168. doi: 10.1097/MCP.0000000000000637. |
| 38055196 | Result | Verleden SE, Hendriks JMH, Snoeckx A, Mai C, Mentens Y, Callebaut W, De Belie B, Van Schil PE, Verplancke V, Janssens A, Jacob J, Pakzad A, Conlon TM, Guvenc G, Yildirim AO, Pauwels P, Koljenovic S, Kwakkel-Van Erp JM, Lapperre TS. Small Airway Disease in Pre-Chronic Obstructive Pulmonary Disease with Emphysema: A Cross-Sectional Study. Am J Respir Crit Care Med. 2024 Mar 15;209(6):683-692. doi: 10.1164/rccm.202301-0132OC. |
| 39219564 | Result | Sudi A, Santa B, Horvath A, Tomisa G, Abonyi-Toth Z, Rokszin G, Eszes N, Muller V, Tamasi L. The Real-World Efficacy of Fixed Triple Inhalation Therapy in the Treatment of Moderate COPD Patients (RATIONALE Study). Int J Chron Obstruct Pulmon Dis. 2024 Aug 28;19:1943-1955. doi: 10.2147/COPD.S474354. eCollection 2024. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| C523187 | fluticasone furoate |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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