The Efficacy and Safety of Once-daily Fluticasone Furoate/Umeclidinium/Vilanterol Versus Twice-daily Budesonide/Formoterol in a Subgroup of Patients from China with Symptomatic COPD at Risk of Exacerbations (FULFIL Trial)

Abstract

The FULFIL study evaluated once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100 µg/62.5 µg/25 µg versus twice-daily budesonide/formoterol (BUD/FOR) 400 µg/12 µg in patients with symptomatic COPD at risk of exacerbations. FULFIL demonstrated clinically meaningful and statistically significant improvements at Week 24 in trough forced expiratory volume in 1 second (FEV₁), St George’s Respiratory Questionnaire (SGRQ) Total scores and reduced exacerbation frequency. Predefined analyses were performed to evaluate treatment effects in a subgroup of patients recruited in China (China subgroup; FF/UMEC/VI, n = 32; BUD/FOR, n = 29). Analyses included treatment by region (China versus non-China) to allow estimated treatment effects in patients from China to be compared with those of the non-China subgroup and the overall FULFIL intent-to-treat (ITT) population. In the China subgroup at Week 24: the mean change from baseline in trough FEV₁ was 125 mL (95% confidence interval [CI] 36, 214) for FF/UMEC/VI and -70 mL (95% CI -163, 23) BUD/FOR (between-treatment difference: 195 mL [95% CI 67, 323]; p = 0.003) and in SGRQ Total score was -5.6 units (95% CI -10.5, -0.7) and -0.3 units (95% CI -5.4, 4.7), respectively (between-treatment difference: -5.3 [95% CI -12.3, 1.7]; p = 0.140). Fewer moderate/severe exacerbations occurred with FF/UMEC/VI than BUD/FOR (16% and 28%, respectively). The overall incidence of adverse events was similar between arms (FF/UMEC/VI: 38%; BUD/FOR: 31%). This prespecified subgroup analysis of patients recruited in China to FULFIL demonstrated comparable efficacy and safety to that observed in the non-China and in the overall ITT populations, for FF/UMEC/VI versus BUD/FOR.

Keywords:

• China
• health-related quality of life
• lung function
• single inhaler triple therapy

ClinicalTrials.gov Identifier::

• NCT02345161
• GSK study CTT116853

Acknowledgments

We would like to thank the patients for participating in this study, the study investigators and their staff, and the FULFIL study team.

Medical writing support in the form of development of the draft outline and manuscript drafts in consultation with the authors, editorial suggestions to draft versions of this paper, assembling tables and figures, collating author comments, copyediting, referencing and graphic services was provided by Thomas Burton, BMBS and Louise Kelly, BSc, of Gardiner-Caldwell Communications, Macclesfield, UK, and was funded by GSK.

ELLIPTA is owned by or licensed to the GSK group of companies; Turbuhaler is a registered trademark of AstraZeneca.

Disclosure statement

• Jinping Zheng: participating in advisory board activities for GSK

• Nanshan Zhong: no conflicts of interest

• Changzheng Wang: no conflicts of interest

• Yijiang Huang: no conflicts of interest

• Ping Chen: no conflicts of interest

• Limin Wang: no conflicts of interest

• Fuxin Hui: no conflicts of interest

• Li Zhao: no conflicts of interest

• Haoyan Wang: no conflicts of interest

• Linda Luo: employee of GSK

• Xin Duo: employee of GSK and holds stock options/shares

• Aik Han Goh: employee of GSK and holds stock options/shares

• David A Lipson: employee of GSK and holds stock options/shares

Additional information

Funding

This study was funded by GSK (study number CTT116853).