P272 Improvements in exacerbation rates with single inhaler triple therapy versus dual ics/laba therapy in patients with advanced chronic obstructive pulmonary disease (copd): subgroup analyses of the phase iii fulfil study

Hilton, Emma; Brealey, Noushin; Birk, Ruby; Zhu, Chang‐Qing; Criner, G.J.; Dransfield, M.T.; Halpin, David; Lomas, DA; Lipson, D.A.

doi:10.1136/thoraxjnl-2017-210983.414

Cited by 2 publications

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“…This study has previously been presented in abstract form at the 2017 ERS International Congress (Milan, Italy) [ 13 ] and the 2017 British Thoracic Society Winter Meeting (London, UK) [ 14 ].…”

Section: Acknowledgementsmentioning

confidence: 99%

Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses

Halpin

Birk²,

Brealey³

et al. 2018

ERJ Open Res

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Triple inhaled corticosteroid (ICS)/long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) therapy is recommended for symptomatic patients with chronic obstructive pulmonary disease (COPD) and at risk of exacerbations. However, the benefits versus side-effects of triple inhaled therapy for COPD, based on distinct patient clinical profiles, are unclear.FULFIL, a phase III, randomised, double-blind study, compared 24 weeks of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 µg using the Ellipta inhaler with twice-daily budesonide/formoterol (BUD/FOR) 400/12 µg using the Turbuhaler. Subgroup analyses of forced expiratory volume in 1 s (FEV1), St George's Respiratory Questionnaire (SGRQ) Total score and exacerbation rates were carried out. Subgroups were defined by COPD medication at screening (ICS+LABA, BUD+FOR, ICS+LABA+LAMA, LAMA alone, tiotropium alone and LAMA+LABA), by disease severity (lung function and exacerbations) and by exacerbation history (exacerbation severity and frequency).In the intent-to-treat population (n=1810) at week 24, FF/UMEC/VI (n=911) versus BUD/FOR (n=899) improved FEV1 and SGRQ Total score and reduced mean annual exacerbation rates in all disease severity and exacerbation history subgroups. FF/UMEC/VI versus BUD/FOR improved FEV1 and SGRQ Total score in all medication subgroups and reduced mean annual exacerbation rates in all medication subgroups, except LAMA+LABA. Adverse events were similar across subgroups.These findings support the benefit of FF/UMEC/VI compared with dual ICS/LABA therapy in patients with symptomatic COPD regardless of disease severity or prior treatment and may help to inform clinical decision making.

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Section: Acknowledgementsmentioning

confidence: 99%

Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses

Halpin

Birk²,

Brealey³

et al. 2018

ERJ Open Res

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“…A full-text analysis led to the removal of 90, leaving 15 records (seven abstracts/posters) belonging to six studies for inclusion ( Fig. 1) [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30]. Detailed reasons for exclusion are outlined in Additional file 1: Table S3.…”

Section: Resultsmentioning

confidence: 99%

Single-inhaler triple therapy in patients with chronic obstructive pulmonary disease: a systematic review

Langham¹,

Lewis²,

Pooley³

et al. 2019

Respir Res

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Background: Guidelines recommend that treatment with a long-acting β 2 agonist (LABA), a long-acting muscarinic antagonist (LAMA), and inhaled corticosteroids (ICS), i.e. triple therapy, is reserved for a select group of symptomatic patients with chronic obstructive pulmonary disease (COPD) who continue to exacerbate despite treatment with dual therapy (LABA/LAMA). A number of single-inhaler triple therapies are now available and important clinical questions remain over their role in the patient pathway. We compared the efficacy and safety of single-inhaler triple therapy to assess the magnitude of benefit and to identify patients with the best risk-benefit profile for treatment. We also evaluated and compared study designs and population characteristics to assess the strength of the evidence base. Methods: We conducted a systematic search, from inception to December 2018, of randomised controlled trials (RCTs) of single-inhaler triple therapy in patients with COPD. The primary outcome was the annual rate of moderate and severe exacerbations. Results: We identified 523 records, of which 15 reports/abstracts from six RCTs were included. Triple therapy resulted in the reduction of the annual rate of moderate or severe exacerbations in the range of 15-52% compared with LAMA/LABA, 15-35% compared to LABA/ICS and 20% compared to LAMA. The patient-based number needed to treat for the moderate or severe exacerbation outcome ranged between approximately 25-50 (preventing one patient from having an event) and the event-based number needed to treat of around 3-11 (preventing one event). The absolute benefit appeared to be greater in patients with higher eosinophil counts or historical frequency of exacerbations and ex-smokers. In the largest study, there was a significantly higher incidence of pneumonia in the triple therapy arm. There were important differences in study designs and populations impacting the interpretation of the results and indicating there would be significant heterogeneity in cross-trial comparisons. Conclusion: The decision to prescribe triple therapy should consider patient phenotype, magnitude of benefit and increased risk of adverse events. Future research on specific patient phenotype thresholds that can support treatment and funding decisions is now required from well-designed, robust, clinical trials. Trial registration: PROSPERO #CRD42018102125.

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P272 Improvements in exacerbation rates with single inhaler triple therapy versus dual ics/laba therapy in patients with advanced chronic obstructive pulmonary disease (copd): subgroup analyses of the phase iii fulfil study

Cited by 2 publications

References 0 publications

Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses

Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses

Single-inhaler triple therapy in patients with chronic obstructive pulmonary disease: a systematic review

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