PMID- 25830381
OWN - NLM
STAT- MEDLINE
DCOM- 20151201
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 31
IP  - 6
DP  - 2015 Jun
TI  - Efficacy and safety of fluticasone furoate/vilanterol (50/25 mcg; 100/25 mcg; 
      200/25 mcg) in Asian patients with chronic obstructive pulmonary disease: a 
      randomized placebo-controlled trial.
PG  - 1191-200
LID - 10.1185/03007995.2015.1036016 [doi]
AB  - BACKGROUND AND OBJECTIVE: Three strengths of fluticasone furoate/vilanterol 
      (FF/VI) were previously evaluated for the treatment of chronic obstructive 
      pulmonary disease (COPD) in a program of global Phase 3 studies that included 
      only a small subgroup of Asian patients. This study further evaluated the 
      efficacy and safety of the same three strengths of FF/VI exclusively in Asian 
      patients. METHODS: A randomized, double-blind, placebo-controlled, 
      parallel-group, multicenter study. Patients with post-bronchodilator FEV1/FVC 
      </=0.70, FEV1 </=70% predicted and modified Medical Research Council score >/=2 were 
      randomized (1:1:1:1) to placebo, FF/VI 50/25 mcg, 100/25 mcg or 200/25 mcg once 
      daily via the ELLIPTA dry powder inhaler. The primary efficacy endpoint was 
      change from baseline in trough FEV1 at Week 24. RESULTS: The intent-to-treat 
      population comprised 643 patients. Statistically significant (p < 0.001) 
      improvements in trough FEV1 were observed with all strengths of FF/VI versus 
      placebo at Week 24 (0.14-0.19 L). Reduction of supplemental albuterol use was 
      observed with all strengths of FF/VI versus placebo. The incidence of 
      on-treatment adverse events (AEs) was 48% with FF/VI 200/25 mcg and 37-40% with 
      other treatments. The incidence of on-treatment serious AEs was 4-9% with FF/VI 
      treatments versus 9% with placebo; however, the study only covered a 6 month 
      treatment period and was not powered to assess effects on exacerbations. No 
      clinically significant treatment effects versus placebo were identified for 
      electrocardiogram, vital signs, 24 hour urinary cortisol excretion and pneumonia. 
      CONCLUSIONS: All strengths of FF/VI improved lung function with an acceptable 
      safety profile. There is no evidence to suggest that dose adjustment may be 
      required in Asian patients using FF/VI 100/25 mcg for the treatment of COPD. 
      CLINICAL TRIAL REGISTRATION: NCT01376245.
FAU - Zheng, Jinping
AU  - Zheng J
AD  - State Key Lab of Respiratory Disease, National Clinical Research Centre of 
      Respiratory Disease, 1st Affiliated Hospital of Guangzhou Medical University , 
      Guangzhou , China.
FAU - de Guia, Teresita
AU  - de Guia T
FAU - Wang-Jairaj, Jie
AU  - Wang-Jairaj J
FAU - Newlands, Amy H
AU  - Newlands AH
FAU - Wang, Changzheng
AU  - Wang C
FAU - Crim, Courtney
AU  - Crim C
FAU - Zhong, Nanshan
AU  - Zhong N
LA  - eng
SI  - ClinicalTrials.gov/NCT01376245
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Androstadienes)
RN  - 0 (Benzyl Alcohols)
RN  - 0 (Chlorobenzenes)
RN  - 0 (Drug Combinations)
RN  - 0 (Glucocorticoids)
RN  - 028LZY775B (vilanterol)
RN  - JS86977WNV (fluticasone furoate)
RN  - QF8SVZ843E (Albuterol)
RN  - WI4X0X7BPJ (Hydrocortisone)
SB  - IM
MH  - Administration, Inhalation
MH  - Aged
MH  - Albuterol/therapeutic use
MH  - Androstadienes/*administration & dosage/adverse effects
MH  - Asian People
MH  - Benzyl Alcohols/*administration & dosage/adverse effects
MH  - Chlorobenzenes/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Dry Powder Inhalers
MH  - Female
MH  - Glucocorticoids/adverse effects
MH  - Humans
MH  - Hydrocortisone/metabolism
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Bronchodilator agents
OT  - COPD
OT  - Clinical respiratory medicine
OT  - Clinical trials
OT  - Respiratory function test
EDAT- 2015/04/02 06:00
MHDA- 2015/12/15 06:00
CRDT- 2015/04/02 06:00
PHST- 2015/04/02 06:00 [entrez]
PHST- 2015/04/02 06:00 [pubmed]
PHST- 2015/12/15 06:00 [medline]
AID - 10.1185/03007995.2015.1036016 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2015 Jun;31(6):1191-200. doi: 10.1185/03007995.2015.1036016.