Asthma Control with ICS-formoterol Reliever Versus Maintenance ICS and SABA Reliever Therapy: a Post Hoc Analysis of Two Randomised Controlled Trials

Overview

Journal BMJ Open Respir Res

Date 2022 Aug 25

PMID 36007980

Authors

Lee Hatter

Claire Houghton

Pepa Bruce

Mark Holliday

Allie Eathorne

Ian Pavord

Helen K Reddel

Robert J Hancox

Irene Braithwaite

Karen Oldfield

Alberto Papi

Mark Weatherall

Richard Beasley

Affiliations

Soon will be listed here.

Abstract

Background: In randomised controlled trials, as-needed inhaled corticosteroid (ICS)-formoterol reliever therapy reduces severe exacerbation risk compared with maintenance ICS plus short-acting beta-agonist (SABA) reliever in adolescent and adult asthma, but results in slightly worse control of asthma symptoms, as measured by mean Asthma Control Questionnaire-5 (ACQ-5) score.

Objective: To assess the levels and changes in asthma control for as-needed budesonide-formoterol versus maintenance budesonide plus SABA in post hoc analyses from the Novel START and PRACTICAL clinical trials.

Methods: The number and proportion of participants at study end in each ACQ-5 category ('well-controlled', 'partly controlled' or 'inadequately controlled' symptoms), and in each responder category based on the minimal clinically important difference for ACQ-5 of 0.5 (improved, no change and worse) with as-needed budesonide-formoterol and maintenance budesonide plus SABA treatment were calculated.

Results: With last observation carried forwards, 189/214 (88.3%) and 354/434 (81.6%) of patients in the budesonide-formoterol group had 'well-controlled' or 'partly controlled' symptoms at the end of the study, vs 183/214 (85.5%) and 358/431 (83.1%) in the budesonide maintenance group, for Novel START and PRACTICAL, respectively. The proportion of patients whose symptom control was either improved or unchanged from baseline was 190/214 (88.8%) and 368/434 (84.8%) for budesonide-formoterol, vs 185/214 (86.4%) and 376/431 (87.2%) for maintenance budesonide, in Novel START and PRACTICAL respectively.

Conclusions: There were no clinically important differences in the proportions of patients with 'well-controlled' or 'partly controlled' asthma symptoms, or proportions who improved or maintained their level of control, with as-needed budesonide-formoterol versus maintenance budesonide plus SABA.

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References

Bateman E, Reddel H, OByrne P, Barnes P, Zhong N, Keen C . As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl J Med. 2018; 378(20):1877-1887. DOI: 10.1056/NEJMoa1715275. View

Juniper E, Svensson K, Mork A, Stahl E . Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med. 2005; 99(5):553-8. DOI: 10.1016/j.rmed.2004.10.008. View

Hatter L, Bruce P, Braithwaite I, Holliday M, Fingleton J, Weatherall M . ICS-formoterol reliever ICS and short-acting β-agonist reliever in asthma: a systematic review and meta-analysis. ERJ Open Res. 2021; 7(1). PMC: 7836558. DOI: 10.1183/23120541.00701-2020. View

Rogliani P, Ritondo B, Ora J, Cazzola M, Calzetta L . SMART and as-needed therapies in mild-to-severe asthma: a network meta-analysis. Eur Respir J. 2020; 56(3). DOI: 10.1183/13993003.00625-2020. View

Williams L, Joseph C, Peterson E, Wells K, Wang M, Chowdhry V . Patients with asthma who do not fill their inhaled corticosteroids: a study of primary nonadherence. J Allergy Clin Immunol. 2007; 120(5):1153-9. DOI: 10.1016/j.jaci.2007.08.020. View

Foster J, Beasley R, Braithwaite I, Harrison T, Holliday M, Pavord I . Perspectives of mild asthma patients on maintenance versus as-needed preventer treatment regimens: a qualitative study. BMJ Open. 2022; 12(1):e048537. PMC: 8785165. DOI: 10.1136/bmjopen-2020-048537. View

Baggott C, Reddel H, Hardy J, Sparks J, Holliday M, Corin A . Patient preferences for symptom-driven or regular preventer treatment in mild to moderate asthma: findings from the PRACTICAL study, a randomised clinical trial. Eur Respir J. 2020; 55(4). DOI: 10.1183/13993003.02073-2019. View

Beasley R, Holliday M, Reddel H, Braithwaite I, Ebmeier S, Hancox R . Controlled Trial of Budesonide-Formoterol as Needed for Mild Asthma. N Engl J Med. 2019; 380(21):2020-2030. DOI: 10.1056/NEJMoa1901963. View

Bender B, Pedan A, Varasteh L . Adherence and persistence with fluticasone propionate/salmeterol combination therapy. J Allergy Clin Immunol. 2006; 118(4):899-904. DOI: 10.1016/j.jaci.2006.07.002. View

10.

Wu A, Butler M, Li L, Fung V, Kharbanda E, Larkin E . Primary adherence to controller medications for asthma is poor. Ann Am Thorac Soc. 2015; 12(2):161-6. PMC: 4342835. DOI: 10.1513/AnnalsATS.201410-459OC. View

11.

Foster J, Beasley R, Braithwaite I, Harrison T, Holliday M, Pavord I . Patient experiences of as-needed budesonide-formoterol by Turbuhaler® for treatment of mild asthma; a qualitative study. Respir Med. 2020; 175:106154. DOI: 10.1016/j.rmed.2020.106154. View

12.

Hardy J, Baggott C, Fingleton J, Reddel H, Hancox R, Harwood M . Budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): a 52-week, open-label, multicentre, superiority, randomised controlled trial. Lancet. 2019; 394(10202):919-928. DOI: 10.1016/S0140-6736(19)31948-8. View

13.

OByrne P, FitzGerald J, Bateman E, Barnes P, Zhong N, Keen C . Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. N Engl J Med. 2018; 378(20):1865-1876. DOI: 10.1056/NEJMoa1715274. View

14.

Juniper E, Bousquet J, Abetz L, Bateman E . Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respir Med. 2005; 100(4):616-21. DOI: 10.1016/j.rmed.2005.08.012. View