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01.12.2015 | Research article | Ausgabe 1/2015 Open Access

BMC Pulmonary Medicine 1/2015

Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials

Zeitschrift:
BMC Pulmonary Medicine > Ausgabe 1/2015
Autoren:
Annette S. Gross, Caroline Goldfrad, Soichiro Hozawa, Mark H. James, Christine S. Clifton, Yutaro Sugiyama, Loretta Jacques
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s12890-015-0159-z) contains supplementary material, which is available to authorized users.

Competing interests

This analysis was funded by GSK, and the studies included in the analysis were sponsored by GSK (GSK study numbers HZA106827 [Clinicaltrials.gov registration number: NCT01165138, registered on July 15 2010]; HZA106829 [NCT01134042, May 27, 2010]; HZA106837 [NCT01086384, March 11, 2010]; FFA109685 [NCT00603278, December 27, 2007]; and FFA109687 [NCT00603382, December 27, 2007]).
ASG, CG, MHJ, CSC and LJ are employed by and are shareholders in GSK. YS is employed by GSK. SH has, within the previous 3 years, received honoraria for lectures from Abbott Japan, Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Eisai, GSK, Kyorin Pharmaceutical, Merck, Sharp & Dohme, Novartis Pharma, and Teijin Pharma.

Authors’ contributions

ASG, CG, MHJ, CSC and LJ contributed to the conception and design of this study; CG, SH and YS contributed to the data analysis; and ASG, CG, SH, MHJ, CSC, YS and LJ contributed to the interpretation of the results. All authors were involved in drafting the manuscript, or revising it critically, and have given approval for publication of the final version.

Abstract

Background

Fluticasone furoate (FF)/vilanterol (VI) is a once daily (OD) inhaled corticosteroid/long-acting β2-agonist combination asthma therapy approved in Japan and the EU. FF/VI efficacy and safety data from asthma studies including patients in East Asia were evaluated to assess ethnic sensitivity.

Methods

Randomized, double-blind, multicenter Phase IIb/III trials were assessed. Change from baseline relative to placebo or twice-daily fluticasone propionate 500 μg in trough FEV1 was compared between patients from Japan (N = 148) and Not-Japan (N = 3,066; three studies). Adverse events (AEs), laboratory results, and electrocardiograms were compared between patients from Japan + Korea (N = 188) and Not-Japan + Korea (N = 3,840; five studies).

Results

For trough FEV1, improvements from baseline (least-squares mean difference [95 % confidence interval]) were reported for FF/VI 100/25 μg OD versus placebo at Week 12 (Japan: 0.323 L [0.104–0.542]; Not-Japan: 0.168 L [0.095–0.241]). Improvements from baseline (least-squares mean change [standard error]) were reported with FF/VI 200/25 μg OD at Week 24 (Japan: 0.355 L [0.1152]; Not-Japan: 0.396 L [0.0313]). A greater proportion of patients from Japan + Korea versus Not-Japan + Korea reported AEs in all treatment arms including placebo (FF/VI 100/25 μg: 79 % versus 57 %; FF/VI 200/25 μg: 64 % versus 45 %; placebo: 41 % versus 23 %). There were no notable differences in treatment-related or class-related AEs. No clinically significant changes in electrocardiogram assessments or statistically significant differences in 24 h urinary cortisol excretion were observed between the Japan + Korea and Not-Japan + Korea cohorts.

Conclusions

Good efficacy and an acceptable safety profile were observed for FF/VI 100/25 μg and 200/25 μg OD in East Asian asthma patients; these globally recommended doses are appropriate for asthma patients in Japan.

Trial registration

Clinicaltrials.gov registration numbers: NCT01165138, NCT01134042, NCT01086384, NCT00603278, NCT00603382.
Zusatzmaterial
Additional file 1: Profile of the three Phase III studies included in both the efficacy and safety analyses. (DOCX 47.4 KB)
12890_2015_159_MOESM1_ESM.docx
Additional file 2: Profile of the two additional Phase IIb studies included in only the safety analyses. (DOCX 25.6 KB)
12890_2015_159_MOESM2_ESM.docx
Additional file 3: List of Institutions and Independent Ethics Committees/Institutional Review Boards for Studies HZA106829, HZA106827, HZA106837, FFA109685, FFA109687 Study HZA106829: 63 Centres. (DOCX 100 KB)
12890_2015_159_MOESM3_ESM.docx
Additional file 4: Adjusted treatment differences from baseline in trough FEV1 at Week 12 (Efficacy population). (DOCX 1.49 MB)
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Additional file 5: Ease of use of the ELLIPTA® dry powder inhaler (DPI; ELLIPTA® is a trademark of the GlaxoSmithKline group of companies). (DOCX 22.5 KB)
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Additional file 6: Summary of ease of use assessment and responses to questions on the ELLIPTA DPI by patients from Japan (HZA106827 ITT population). (DOCX 25.2 KB)
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Additional file 7: Summary of exposure in each treatment arm (Safety population). (DOCX 26.5 KB)
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Additional file 8: AEs reported by ≥3 patients in the Japan+Korea cohort of any relevant treatment arm and the corresponding incidence in the Not-Japan+Korea cohort and the Overall population (Safety population). (DOCX 26.9 KB)
12890_2015_159_MOESM8_ESM.docx
Additional file 9: Region ratios of ‘treatment effect’ in Japan+Korea and Not-Japan+Korea patients, where ‘treatment effect’ is the comparison between treatment arms of 24h urinary cortisol excretion ratio (end of treatment/baseline; Urinary Cortisol population). (DOCX 944 KB)
12890_2015_159_MOESM9_ESM.docx
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