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)

• Published in: Chronic obstructive pulmonary disease Vol. 15; no. 4; pp. 334 - 340
• Main Authors: Zheng, Jinping, Zhong, Nanshan, Wang, Changzheng, Huang, Yijiang, Chen, Ping, Wang, Limin, Hui, Fuxin, Zhao, Li, Wang, Haoyan, Luo, Linda, Du, Xin, Han Goh, Aik, Lipson, David A.
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 04.07.2018
• Subjects: Aged; Androstadienes - therapeutic use; Benzyl Alcohols - therapeutic use; Bronchodilator Agents - therapeutic use; Budesonide, Formoterol Fumarate Drug Combination - therapeutic use; China; Chlorobenzenes - therapeutic use; Disease Progression; Double-Blind Method; Drug Combinations; Female; Forced Expiratory Volume; Glucocorticoids - therapeutic use; GSK study CTT116853; Health Status; health-related quality of life; Humans; lung function; Male; Middle Aged; NCT02345161; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Quality of Life; Quinuclidines - therapeutic use; single inhaler triple therapy; Spirometry; Treatment Outcome; Vital Capacity; China; GSK study CTT116853; NCT02345161; single inhaler triple therapy; health-related quality of life; lung function; China
• ISSN: 1541-2555; 1541-2563
• DOI: 10.1080/15412555.2018.1481022

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 (FEV 1 ), 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 FEV 1 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.