ICS/Ultra LABA in the Treatment of Obstructive Airway Diseases: A Consensus of Indian Experts

Overview

Journal Adv Respir Med

Publisher MDPI

Specialties Allergy & Immunology
Pulmonary Medicine

Date 2022 Oct 26

PMID 36285979

Authors

Raja Dhar

Deepak Talwar

Prince James

Ashwini Mishra

Judo Vachaparambil

Saiprasad Patil

Nishtha Khatri

Sagar Bhagat

Hanmant Barkate

Affiliations

Soon will be listed here.

Abstract

Inhaled corticosteroid and ultra-long-acting beta-agonist (ICS/uLABA) combination is a recent advancement in the armamentarium against obstructive airways diseases (OADs). The combination of ICS/uLABA has several advantages, creating a favorable landscape for its utilization. Fluticasone furoate/vilanterol trifenatate (FF/Vi) is one such example of an ICS/uLABA. It offers several benefits from both drugs, such as a convenient once daily dosing schedule; high lipophilicity; high receptor affinity of fluticasone furoate along with high functional selectivity and a quick onset of action of vilanterol. However, the Global Initiative for Asthma (GINA) as well as the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines do not clearly define the positioning of ICS/uLABA compared to conventional ICS/LABAs. There are a few areas of uncertainty especially around the appropriate reliever strategy with ICS/uLABA in Asthma. The current consensus was planned with a group of Indian pulmonology experts to provide more clarity on the potential use of FF/Vi in Asthma and COPD. The clinical statements highlighted in this consensus manuscript address crucial clinical questions revolving around the efficacy and safety of FF/Vi as compared to conventional ICS/LABAs and identify the ideal patient profile for its use. This consensus paper also sheds light upon the appropriate reliever to be used along with FF/Vi in Asthma and the utilization of FF/Vi-based triple therapy in OADs. Expert recommendations mentioned in this paper will serve as guidance to pulmonologists as well as consultant physicians who are involved in providing care to OAD patients and will help them weigh the various factors that need to be taken into account while prescribing ICS/uLABA combination.

References

Slack R, Barrett V, Morrison V, Sturton R, Emmons A, Ford A . In vitro pharmacological characterization of vilanterol, a novel long-acting β2-adrenoceptor agonist with 24-hour duration of action. J Pharmacol Exp Ther. 2012; 344(1):218-30. DOI: 10.1124/jpet.112.198481. View

Bernstein D, Bateman E, Woodcock A, Toler W, Forth R, Jacques L . Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma. J Asthma. 2015; 52(10):1073-83. DOI: 10.3109/02770903.2015.1056350. View

Kerwin E, Scott-Wilson C, Sanford L, Rennard S, Agusti A, Barnes N . A randomised trial of fluticasone furoate/vilanterol (50/25 μg; 100/25 μg) on lung function in COPD. Respir Med. 2013; 107(4):560-9. DOI: 10.1016/j.rmed.2012.12.014. View

Furuhashi K, Fujisawa T, Hashimoto D, Kamiya Y, Yasui H, Karayama M . 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; 12:253-261. PMC: 6756272. DOI: 10.2147/JAA.S223093. View

Rogliani P, Calzetta L, Braido F, Cazzola M, Clini E, Pelaia G . LABA/LAMA fixed-dose combinations in patients with COPD: a systematic review. Int J Chron Obstruct Pulmon Dis. 2018; 13:3115-3130. PMC: 6174911. DOI: 10.2147/COPD.S170606. View

Braithwaite I, Williams M, Power S, Pilcher J, Weatherall M, Baines A . Randomised, double-blind, placebo-controlled, cross-over single dose study of the bronchodilator duration of action of combination fluticasone furoate/vilanterol inhaler in adult asthma. Respir Med. 2016; 119:115-121. DOI: 10.1016/j.rmed.2016.09.006. View

Chapman K, An L, Bosnic-Anticevich S, Campomanes C, Espinosa J, Jain P . Asthma patients' and physicians' perspectives on the burden and management of asthma. Respir Med. 2021; 186:106524. DOI: 10.1016/j.rmed.2021.106524. View

Bardsley G, Daley-Yates P, Baines A, Kempsford R, Williams M, Mallon T . Anti-inflammatory duration of action of fluticasone furoate/vilanterol trifenatate in asthma: a cross-over randomised controlled trial. Respir Res. 2018; 19(1):133. PMC: 6044077. DOI: 10.1186/s12931-018-0836-6. View

Hartley B, Barnes N, Lettis S, Compton C, Papi A, Jones P . Risk factors for exacerbations and pneumonia in patients with chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2020; 21(1):5. PMC: 6945447. DOI: 10.1186/s12931-019-1262-0. View

10.

Svedsater H, Jones R, Bosanquet N, Jacques L, Lay-Flurrie J, Leather D . 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. View

11.

Stone I, Barnes N, James W, Midwinter D, Boubertakh R, Follows R . Lung Deflation and Cardiovascular Structure and Function in Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2015; 193(7):717-26. PMC: 5440091. DOI: 10.1164/rccm.201508-1647OC. View

12.

Calzetta L, Ritondo B, De Marco P, Cazzola M, Rogliani P . Evaluating triple ICS/LABA/LAMA therapies for COPD patients: a network meta-analysis of ETHOS, KRONOS, IMPACT, and TRILOGY studies. Expert Rev Respir Med. 2020; 15(1):143-152. DOI: 10.1080/17476348.2020.1816830. View

13.

Qureshi H, Sharafkhaneh A, Hanania N . Chronic obstructive pulmonary disease exacerbations: latest evidence and clinical implications. Ther Adv Chronic Dis. 2014; 5(5):212-27. PMC: 4131503. DOI: 10.1177/2040622314532862. View

14.

Sin D, Paul Man S . Pharmacotherapy for mortality reduction in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2006; 3(7):624-9. DOI: 10.1513/pats.200603-096SS. View

15.

Bianco A, Contoli M, Di Marco F, Mennini F, Papi A . As-needed anti-inflammatory reliever therapy for asthma management: evidence and practical considerations. Clin Exp Allergy. 2020; 51(7):873-882. DOI: 10.1111/cea.13795. View

16.

Kerkhof M, Voorham J, Dorinsky P, Cabrera C, Darken P, Kocks J . The Long-Term Burden of COPD Exacerbations During Maintenance Therapy and Lung Function Decline. Int J Chron Obstruct Pulmon Dis. 2020; 15:1909-1918. PMC: 7418151. DOI: 10.2147/COPD.S253812. View

17.

Stanford R, Parker E, Reinsch T, Buikema A, Blauer-Peterson C . Assessment of COPD-related outcomes in patients initiating a once daily or twice daily ICS/LABA. Respir Med. 2019; 150:1-7. DOI: 10.1016/j.rmed.2019.01.019. View

18.

Calzetta L, Rinaldi B, Cazzola M, Matera M . Pharmacodynamic and pharmacokinetic assessment of fluticasone furoate + vilanterol for the treatment of asthma. Expert Opin Drug Metab Toxicol. 2016; 12(7):813-22. DOI: 10.1080/17425255.2016.1192125. View

19.

Lipson D, Crim C, Criner G, Day N, Dransfield M, Halpin D . Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2020; 201(12):1508-1516. PMC: 7301738. DOI: 10.1164/rccm.201911-2207OC. View

20.

Rogliani P, Ritondo B, Calzetta L . Triple therapy in uncontrolled asthma: a network meta-analysis of phase III studies. Eur Respir J. 2021; 58(3). DOI: 10.1183/13993003.04233-2020. View