PMID- 34262299
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220424
IS  - 1178-6965 (Print)
IS  - 1178-6965 (Electronic)
IS  - 1178-6965 (Linking)
VI  - 14
DP  - 2021
TI  - Safety of Once-Daily Single-Inhaler Triple Therapy with Fluticasone 
      Furoate/Umeclidinium/Vilanterol in Japanese Patients with Asthma: A Long-Term 
      (52-Week) Phase III Open-Label Study.
PG  - 809-819
LID - 10.2147/JAA.S305918 [doi]
AB  - PURPOSE: The pivotal CAPTAIN study reported a favorable safety profile with 
      once-daily inhaled corticosteroid/long-acting muscarinic antagonist/long-acting 
      beta(2)-agonist (ICS/LAMA/LABA) triple combination of fluticasone 
      furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with inadequately 
      controlled asthma, some of whom were Japanese. Here, we evaluate the long-term 
      (52 weeks) safety of FF/UMEC/VI in Japanese patients with asthma. PATIENTS AND 
      METHODS: This was a Phase III, 52-week, multicenter, non-comparator, 
      non-randomized, open-label study (NCT03184987) in Japanese adults receiving 
      maintenance therapy with ICS/LABA, with or without LAMA. At enrollment, patients 
      were allocated to either FF/UMEC/VI 100/62.5/25mcg (Group 1) or 200/62.5/25mcg 
      (Group 2). Patients in Group 1 could have their treatment stepped up to 
      200/62.5/25mcg at Week 24 if their Asthma Control Questionnaire (ACQ)-7 score was 
      >0.75. The primary endpoint was the incidence of adverse events (AEs) and serious 
      AEs (SAEs). Secondary endpoints included vital signs, electrocardiogram 
      measurements, and clinical laboratory tests (biochemistry, hematology, 
      urinalysis). Efficacy was assessed as "other" endpoints. RESULTS: A total of 111 
      Japanese patients were included in the intention-to-treat (ITT) population. 
      Overall, 77 (69%) patients reported >/=1 AE (Group 1: n=30 [64%]; step-up group: 
      n=7 [78%]; Group 2: n=40 [73%]). SAEs were reported for 1 (2.1%) and 2 (3.6%) 
      patients in Groups 1 and 2, respectively. All SAEs were considered unrelated to 
      study treatment. One AE and one SAE led to study withdrawal: oropharyngeal 
      discomfort (Group 1); eosinophilic granulomatosis with polyangiitis (Group 2). No 
      new safety concerns were identified throughout the 52-week treatment period. 
      CONCLUSION: In this uncontrolled open-label study, no new safety concerns were 
      observed with long-term (52 weeks) treatment with once-daily FF/UMEC/VI among 111 
      Japanese patients with asthma.
CI  - (c) 2021 Hozawa et al.
FAU - Hozawa, Soichiro
AU  - Hozawa S
AD  - Hiroshima Allergy and Respiratory Clinic, Hiroshima, Japan.
FAU - Ohbayashi, Hiroyuki
AU  - Ohbayashi H
AUID- ORCID: 0000-0002-5186-8761
AD  - Tohno Chuo Clinic, Gifu, Japan.
FAU - Tsuchiya, Michiko
AU  - Tsuchiya M
AD  - Department of Respiratory Medicine, Rakuwakai Otowa Hospital, Kyoto, Japan.
FAU - Hara, Yu
AU  - Hara Y
AD  - Department of Pulmonology, Yokohama City University Graduate School of Medicine, 
      Kanagawa, Japan.
FAU - Lee, Laurie A
AU  - Lee LA
AD  - GSK, Collegeville, PA, USA.
FAU - Nakayama, Takashi
AU  - Nakayama T
AUID- ORCID: 0000-0003-1948-6373
AD  - GSK, Tokyo, Japan.
FAU - Tamaoki, Jun
AU  - Tamaoki J
AD  - GSK, Tokyo, Japan.
FAU - Fowler, Andrew
AU  - Fowler A
AD  - GSK, Brentford, Middlesex, UK.
FAU - Nishi, Takanobu
AU  - Nishi T
AUID- ORCID: 0000-0003-2272-6833
AD  - GSK, Tokyo, Japan.
LA  - eng
PT  - Journal Article
DEP - 20210706
PL  - New Zealand
TA  - J Asthma Allergy
JT  - Journal of asthma and allergy
JID - 101543450
PMC - PMC8275015
OTO - NOTNLM
OT  - *Japan
OT  - *asthma
OT  - *inhalers
OT  - *safety
OT  - *treatment outcome
COIS- SH has received honoraria from Astellas Pharma, GSK, Novartis Pharma, 
      AstraZeneca, Kyorin Pharmaceutical, and Sanofi. HO has received honoraria from 
      Kyorin Pharmaceutical, and Mylan EPD GK. MT has no conflicts of interest to 
      disclose. YH has received honoraria from GSK, Novartis Pharma, and AstraZeneca. 
      LAL was an employee of GSK at the time of the study and holds stocks or shares in 
      GSK. TNa and AF are employees of GSK and hold stocks or shares in GSK. TNi and JT 
      are employees of GSK. The authors report no other conflicts of interest in this 
      work.
EDAT- 2021/07/16 06:00
MHDA- 2021/07/16 06:01
PMCR- 2021/07/06
CRDT- 2021/07/15 06:16
PHST- 2021/02/09 00:00 [received]
PHST- 2021/06/03 00:00 [accepted]
PHST- 2021/07/15 06:16 [entrez]
PHST- 2021/07/16 06:00 [pubmed]
PHST- 2021/07/16 06:01 [medline]
PHST- 2021/07/06 00:00 [pmc-release]
AID - 305918 [pii]
AID - 10.2147/JAA.S305918 [doi]
PST - epublish
SO  - J Asthma Allergy. 2021 Jul 6;14:809-819. doi: 10.2147/JAA.S305918. eCollection 
      2021.