Comparison of Budesonide/formoterol versus Fluticasone furoate/vilanterol as maintenance and reliever therapy for asthma control: a real-world observational study.
Humans
Male
Female
Benzyl Alcohols
/ administration & dosage
Retrospective Studies
Asthma
/ drug therapy
Middle Aged
Chlorobenzenes
/ administration & dosage
Adult
Drug Combinations
Bronchodilator Agents
/ administration & dosage
Administration, Inhalation
Androstadienes
/ administration & dosage
Budesonide
/ administration & dosage
Anti-Asthmatic Agents
/ therapeutic use
Aged
Formoterol Fumarate
/ administration & dosage
Treatment Outcome
Nitric Oxide
/ analysis
Budesonide, Formoterol Fumarate Drug Combination
/ administration & dosage
Respiratory Function Tests
Eosinophils
/ drug effects
Journal
BMC pulmonary medicine
ISSN: 1471-2466
Titre abrégé: BMC Pulm Med
Pays: England
ID NLM: 100968563
Informations de publication
Date de publication:
01 Aug 2024
01 Aug 2024
Historique:
received:
09
03
2024
accepted:
30
07
2024
medline:
1
8
2024
pubmed:
1
8
2024
entrez:
31
7
2024
Statut:
epublish
Résumé
Previous studies have reported reduced acute exacerbation rates and improved symptom control in asthma patients treated using inhaled corticosteroids plus formoterol maintenance and reliever therapy (MART). Fluticasone furoate (FF) and vilanterol (VIL) also provide rapid bronchodilation and sustained anti-inflammatory effects, however no studies have investigated FF/VIL as MART for asthma control. From October 1, 2021 to September 30, 2023, this retrospective study included asthma patients classified as step 3 or 4 according to the Global Initiative for Asthma guidelines, who were then divided into two groups. One group received BUD/FOR as MART, while the other received FF/VIL as MART. Pulmonary function tests, exacerbation rates, Asthma Control Test (ACT), fractional exhaled nitric oxide (FeNO) levels, and blood eosinophil counts were measured before and after 12 months of treatment. A total of 161 patients were included, of whom 36 received BUD/FOR twice daily as MART, and 125 received FF/VIL once daily as MART. After 12 months of treatment, the FF/VIL group showed a significant increase in ACT scores by 1.57 (p < 0.001), while the BUD/FOR group had an increase of 0.88 (p = 0.11). In terms of FeNO levels, the BUD/FOR group experienced a decline of -0.2 ppb (p = 0.98), whereas the FF/VIL group had a mild increase of + 0.8 ppb (p = 0.7). Notably, there was a significant difference in the change of FeNO between the two groups (∆ FeNO: -0.2 ppb in BUD/FOR; + 0.8 ppb in FF/VIL, p < 0.001). There were no significant alterations observed in FEV1, blood eosinophil count, or acute exacerbation decline in either group. In the current study, patients treated with FF/VIL as MART showed improvements in ACT scores, while those treated with BUD/FOR as MART exhibited a reduction in FeNO levels. However, the difference between the two treatment groups did not reach clinical significance. Thus, FF/VIL as MART showed similar effectiveness to BUD/FOR as MART.
Sections du résumé
BACKGROUND
BACKGROUND
Previous studies have reported reduced acute exacerbation rates and improved symptom control in asthma patients treated using inhaled corticosteroids plus formoterol maintenance and reliever therapy (MART). Fluticasone furoate (FF) and vilanterol (VIL) also provide rapid bronchodilation and sustained anti-inflammatory effects, however no studies have investigated FF/VIL as MART for asthma control.
METHODS
METHODS
From October 1, 2021 to September 30, 2023, this retrospective study included asthma patients classified as step 3 or 4 according to the Global Initiative for Asthma guidelines, who were then divided into two groups. One group received BUD/FOR as MART, while the other received FF/VIL as MART. Pulmonary function tests, exacerbation rates, Asthma Control Test (ACT), fractional exhaled nitric oxide (FeNO) levels, and blood eosinophil counts were measured before and after 12 months of treatment.
RESULTS
RESULTS
A total of 161 patients were included, of whom 36 received BUD/FOR twice daily as MART, and 125 received FF/VIL once daily as MART. After 12 months of treatment, the FF/VIL group showed a significant increase in ACT scores by 1.57 (p < 0.001), while the BUD/FOR group had an increase of 0.88 (p = 0.11). In terms of FeNO levels, the BUD/FOR group experienced a decline of -0.2 ppb (p = 0.98), whereas the FF/VIL group had a mild increase of + 0.8 ppb (p = 0.7). Notably, there was a significant difference in the change of FeNO between the two groups (∆ FeNO: -0.2 ppb in BUD/FOR; + 0.8 ppb in FF/VIL, p < 0.001). There were no significant alterations observed in FEV1, blood eosinophil count, or acute exacerbation decline in either group.
CONCLUSIONS
CONCLUSIONS
In the current study, patients treated with FF/VIL as MART showed improvements in ACT scores, while those treated with BUD/FOR as MART exhibited a reduction in FeNO levels. However, the difference between the two treatment groups did not reach clinical significance. Thus, FF/VIL as MART showed similar effectiveness to BUD/FOR as MART.
Identifiants
pubmed: 39085818
doi: 10.1186/s12890-024-03190-8
pii: 10.1186/s12890-024-03190-8
doi:
Substances chimiques
Benzyl Alcohols
0
Chlorobenzenes
0
Drug Combinations
0
Bronchodilator Agents
0
Androstadienes
0
Budesonide
51333-22-3
Anti-Asthmatic Agents
0
fluticasone furoate
JS86977WNV
vilanterol
028LZY775B
Formoterol Fumarate
W34SHF8J2K
fluticasone furoate-vilanterol trifenatate
0
Nitric Oxide
31C4KY9ESH
Budesonide, Formoterol Fumarate Drug Combination
0
Types de publication
Journal Article
Observational Study
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
374Informations de copyright
© 2024. The Author(s).
Références
Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002;109(2 Suppl):S447-460.
doi: 10.1067/mai.2002.121409
pubmed: 11842317
Venkatesan P. 2023 GINA report for asthma. Lancet Respir Med. 2023;11(7):589.
doi: 10.1016/S2213-2600(23)00230-8
pubmed: 37302397
Rabe KF, Atienza T, Magyar P, Larsson P, Jorup C, Lalloo UG. Effect of budesonide in combination with formoterol for reliever therapy in asthma exacerbations: a randomised controlled, double-blind study. Lancet. 2006;368(9537):744–53.
doi: 10.1016/S0140-6736(06)69284-2
pubmed: 16935685
Bousquet J, Boulet LP, Peters MJ, Magnussen H, Quiralte J, Martinez-Aguilar NE, Carlsheimer A. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med. 2007;101(12):2437–46.
doi: 10.1016/j.rmed.2007.07.014
pubmed: 17905575
Beasley R, Harrison T, Peterson S, Gustafson P, Hamblin A, Bengtsson T, Fageras M. Evaluation of Budesonide-Formoterol for Maintenance and Reliever Therapy Among Patients With Poorly Controlled Asthma: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022;5(3): e220615.
doi: 10.1001/jamanetworkopen.2022.0615
pubmed: 35230437
pmcid: 8889464
Bateman ED, Reddel HK, FitzGerald JM. As-Needed Budesonide-Formoterol in Mild Asthma. N Engl J Med. 2018;379(9):898.
pubmed: 30157403
Bateman ED, Reddel HK, O’Byrne PM, Barnes PJ, Zhong N, Keen C, Jorup C, Lamarca R, Siwek-Posluszna A, FitzGerald JM. As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl J Med. 2018;378(20):1877–87.
doi: 10.1056/NEJMoa1715275
pubmed: 29768147
Boulet LP, Vervloet D, Magar Y, Foster JM. Adherence: the goal to control asthma. Clin Chest Med. 2012;33(3):405–17.
doi: 10.1016/j.ccm.2012.06.002
pubmed: 22929091
Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011;105(6):930–8.
doi: 10.1016/j.rmed.2011.01.005
pubmed: 21367593
Salter M, Biggadike K, Matthews JL, West MR, Haase MV, Farrow SN, Uings IJ, Gray DW. Pharmacological properties of the enhanced-affinity glucocorticoid fluticasone furoate in vitro and in an in vivo model of respiratory inflammatory disease. Am J Physiol Lung Cell Mol Physiol. 2007;293(3):L660-667.
doi: 10.1152/ajplung.00108.2007
pubmed: 17575011
Slack RJ, Barrett VJ, Morrison VS, Sturton RG, Emmons AJ, Ford AJ, Knowles RG. In vitro pharmacological characterization of vilanterol, a novel long-acting beta2-adrenoceptor agonist with 24-hour duration of action. J Pharmacol Exp Ther. 2013;344(1):218–30.
doi: 10.1124/jpet.112.198481
pubmed: 23131596
Lotvall J, Bateman ED, Bleecker ER, Busse WW, Woodcock A, Follows R, Lim J, Stone S, Jacques L, Haumann B. 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids. Eur Respir J. 2012;40(3):570–9.
doi: 10.1183/09031936.00121411
pubmed: 22362859
Svedsater H, Jones R, Bosanquet N, Jacques L, Lay-Flurrie J, Leather DA, Vestbo J, Collier S, Woodcock A. Patient-reported outcomes with initiation of fluticasone furoate/vilanterol versus continuing usual care in the Asthma Salford Lung Study. Respir Med. 2018;141:198–206.
doi: 10.1016/j.rmed.2018.06.003
pubmed: 30053967
Woodcock A, Vestbo J, Bakerly ND, New J, Gibson JM, McCorkindale S, Jones R, Collier S, Lay-Flurrie J, Frith L, et al. Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial. Lancet. 2017;390(10109):2247–55.
doi: 10.1016/S0140-6736(17)32397-8
pubmed: 28903864
Williams LK, Peterson EL, Wells K, Ahmedani BK, Kumar R, Burchard EG, Chowdhry VK, Favro D, Lanfear DE, Pladevall M. Quantifying the proportion of severe asthma exacerbations attributable to inhaled corticosteroid nonadherence. J Allergy Clin Immunol. 2011;128(6):1185-1191. e1182.
doi: 10.1016/j.jaci.2011.09.011
pubmed: 22019090
pmcid: 3229671
Wells KE, Peterson EL, Ahmedani BK, Williams LK. Real-world effects of once vs greater daily inhaled corticosteroid dosing on medication adherence. Ann Allergy Asthma Immunol. 2013;111(3):216–20.
doi: 10.1016/j.anai.2013.06.008
pubmed: 23987199
pmcid: 3763990
Loh ZC, Hussain R, Balan S, Saini B, Muneswarao J, Ong SC, Babar ZU. Perceptions, attitudes, and behaviors of asthma patients towards the use of short-acting beta2-agonists: A systematic review. PLoS ONE. 2023;18(4): e0283876.
doi: 10.1371/journal.pone.0283876
pubmed: 37079594
pmcid: 10118161
Virchow JC, Backer V, de Blay F, Kuna P, Ljorring C, Prieto JL, Villesen HH. Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement. Respir Med. 2015;109(5):547–56.
doi: 10.1016/j.rmed.2015.01.012
pubmed: 25676887
American Thoracic S, European Respiratory S. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005;171(8):912–30.
doi: 10.1164/rccm.200406-710ST
Beasley R, Bruce P, Houghton C, Hatter L. The ICS/Formoterol Reliever Therapy Regimen in Asthma: A Review. J Allergy Clin Immunol Pract. 2023;11(3):762-772.e761.
doi: 10.1016/j.jaip.2023.01.002
pubmed: 36639054
Lipworth B, Chan R, Kuo CR. Anti-inflammatory reliever therapy for asthma. Ann Allergy Asthma Immunol. 2020;124(1):13–5.
doi: 10.1016/j.anai.2019.10.002
pubmed: 31610234
Lipworth B, Kuo CR, Stewart K, Chan R: Budesonide/formoterol or budesonide/albuterol as anti-inflammatory reliever therapy for asthma. J Allergy Clin Immunol Pract. 2024;12(4):889–93.
Kuna P, Peters MJ, Manjra AI, Jorup C, Naya IP, Martinez-Jimenez NE, Buhl R. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract. 2007;61(5):725–36.
doi: 10.1111/j.1742-1241.2007.01338.x
pubmed: 17362472
Papi A, Corradi M, Pigeon-Francisco C, Baronio R, Siergiejko Z, Petruzzelli S, Fabbri LM, Rabe KF. Beclometasone-formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial. Lancet Respir Med. 2013;1(1):23–31.
doi: 10.1016/S2213-2600(13)70012-2
pubmed: 24321801
Syed YY. Fluticasone furoate/vilanterol: a review of its use in patients with asthma. Drugs. 2015;75(4):407–18.
doi: 10.1007/s40265-015-0354-5
pubmed: 25648266
Derendorf H, Meltzer EO. Molecular and clinical pharmacology of intranasal corticosteroids: clinical and therapeutic implications. Allergy. 2008;63(10):1292–300.
doi: 10.1111/j.1398-9995.2008.01750.x
pubmed: 18782107
Hanania NA, Feldman G, Zachgo W, Shim JJ, Crim C, Sanford L, Lettis S, Barnhart F, Haumann B. The efficacy and safety of the novel long-acting beta2 agonist vilanterol in patients with COPD: a randomized placebo-controlled trial. Chest. 2012;142(1):119–27.
doi: 10.1378/chest.11-2231
pubmed: 22241764
Shimizu Y, Shiobara T, Arai R, Chibana K, Takemasa A. Real-life effectiveness of fluticasone furoate/vilanterol after switching from fluticasone/salmeterol or budesonide/formoterol therapy in patients with symptomatic asthma: Relvar Ellipta for Real Asthma Control Study (RERACS study). J Thorac Dis. 2020;12(5):1877–83.
doi: 10.21037/jtd-19-3913
pubmed: 32642091
pmcid: 7330400
Furuhashi K, Fujisawa T, Hashimoto D, Kamiya Y, Yasui H, Karayama M, Suzuki Y, Hozumi H, Enomoto N, Nakamura Y, et al. Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial. J Asthma Allergy. 2019;12:253–61.
doi: 10.2147/JAA.S223093
pubmed: 31571932
pmcid: 6756272
Dal Negro RW. Dry powder inhalers and the right things to remember: a concept review. Multidiscip Respir Med. 2015;10(1):13.
doi: 10.1186/s40248-015-0012-5
Busse WW, Kraft M, Rabe KF, Deniz Y, Rowe PJ, Ruddy M, Castro M: Understanding the key issues in the treatment of uncontrolled persistent asthma with type 2 inflammation. Eur Respir J. 2021;58(2):2003393.
Bardsley G, Daley-Yates P, Baines A, Kempsford R, Williams M, Mallon T, Braithwaite I, Riddell K, Joshi S, Bareille P, et al. Anti-inflammatory duration of action of fluticasone furoate/vilanterol trifenatate in asthma: a cross-over randomised controlled trial. Respir Res. 2018;19(1):133.
doi: 10.1186/s12931-018-0836-6
pubmed: 30001712
pmcid: 6044077
Dweik RA, Boggs PB, Erzurum SC, Irvin CG, Leigh MW, Lundberg JO, Olin AC, Plummer AL, Taylor DR. American Thoracic Society Committee on Interpretation of Exhaled Nitric Oxide Levels for Clinical A: An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications. Am J Respir Crit Care Med. 2011;184(5):602–15.
doi: 10.1164/rccm.9120-11ST
pubmed: 21885636
pmcid: 4408724
Price DB, Rigazio A, Campbell JD, Bleecker ER, Corrigan CJ, Thomas M, Wenzel SE, Wilson AM, Small MB, Gopalan G, et al. Blood eosinophil count and prospective annual asthma disease burden: a UK cohort study. Lancet Respir Med. 2015;3(11):849–58.
doi: 10.1016/S2213-2600(15)00367-7
pubmed: 26493938
Corren J, Du E, Gubbi A, Vanlandingham R. Variability in blood eosinophil counts in patients with eosinophilic asthma. J Allergy Clin Immunol Pract. 2021;9(3):1224-1231. e1229.
doi: 10.1016/j.jaip.2020.10.033
pubmed: 33130147
Mathur SK, Fichtinger PS, Evans MD, Schwantes EA, Jarjour NN. Variability of blood eosinophil count as an asthma biomarker. Annals of allergy, asthma & immunology: official publication of the American College of Allergy, Asthma, & Immunology. 2016;117(5):551.
doi: 10.1016/j.anai.2016.08.010
Kim Y, Lee H, Chung SJ, Yeo Y, Park TS, Park DW, Min KH, Kim S-H, Kim T-H, Sohn JW: The Usefulness of FEF25–75 in Predicting Airway Hyperresponsiveness to Mannitol. J Asthma Allergy. 2023;60(9):1761–6.
Sagmen SB, Eraslan BZ, Demirer E, Kiral N, Comert S. Small airway disease and asthma control. J Asthma. 2023;60(9):1761–6.
doi: 10.1080/02770903.2023.2185894
pubmed: 36847658