PMID- 22267687
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20121002
LR  - 20220309
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 2
IP  - 1
DP  - 2012
TI  - Efficacy and safety of 4 weeks' treatment with combined fluticasone 
      furoate/vilanterol in a single inhaler given once daily in COPD: a 
      placebo-controlled randomised trial.
PG  - e000370
LID - 10.1136/bmjopen-2011-000370 [doi]
LID - e000370
AB  - Background Fluticasone furoate/vilanterol (FF/VI) is a novel once-daily (OD) 
      inhaled corticosteroid/long-acting beta(2) agonist combination in development for 
      chronic obstructive pulmonary disease (COPD) and asthma. Trial design A 
      multicentre, randomised, double-blind, parallel-group, placebo-controlled study. 
      Methods Participants were patients with moderate-to-severe COPD treated with 
      placebo or FF/VI 400/25 mug OD for 4 weeks. Study objectives were to assess the 
      safety and efficacy of FF/VI 400/25 mug OD administered for 4 weeks via a novel 
      dry powder inhaler. Co-primary end points were change from baseline in weighted 
      mean (wm) heart rate 0-4 h postdose at day 28 and the incidence of adverse events 
      (AEs). Secondary end points included change from baseline in trough forced 
      expiratory volume in one second (FEV(1)) (23-24 h postdose; day 29) and wm FEV(1) 
      (0-4 h postdose; day 28). Patients were randomised to receive FF/VI 400/25 mug or 
      placebo in a 2:1 ratio; all patients and investigators were blinded to active or 
      placebo treatment. Results 60 patients (mean age 64 years) were randomised 
      (FF/VI: n=40; placebo: n=20), and all contributed data to the analysis. Mean 
      screening post-bronchodilator FEV(1) per cent predicted was comparable between 
      groups (FF/VI: 58.5%; placebo: 60.1%). The wm heart rate 0-4 h postdose was 
      similar between groups (difference: 0.6 beats per minute; 95% CI -3.9 to 5.1). 
      More on-treatment AEs were reported in the FF/VI group (68%) compared with the 
      placebo group (50%). The most common drug-related AEs in the FF/VI group were 
      oral candidiasis (8%) and dysphonia (5%). There were no clinically relevant 
      effects on laboratory values, including glucose and potassium, or on vital signs 
      or ECGs/Holters. The FF/VI group had statistically greater improvements compared 
      with placebo in trough FEV(1) (mean difference 183 ml) and 0-4 h postdose wm 
      FEV(1) (mean difference 236 ml). Conclusion FF/VI has a good safety and 
      tolerability profile and improves lung function compared with placebo in patients 
      with COPD. Trial registration number clinical trials.gov-NCT00731822.
FAU - Lotvall, J
AU  - Lotvall J
AD  - Krefting Research Centre, University of Gothenburg, Gothenburg, Sweden.
FAU - Bakke, P S
AU  - Bakke PS
FAU - Bjermer, L
AU  - Bjermer L
FAU - Steinshamn, S
AU  - Steinshamn S
FAU - Scott-Wilson, C
AU  - Scott-Wilson C
FAU - Crim, C
AU  - Crim C
FAU - Sanford, L
AU  - Sanford L
FAU - Haumann, B
AU  - Haumann B
LA  - eng
SI  - ClinicalTrials.gov/NCT00731822
PT  - Journal Article
DEP - 20120119
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
PMC - PMC3263438
COIS- Competing interests: JL has served as a consultant to and received lecture fees 
      from AstraZeneca, GlaxoSmithKline, Merck Sharpe and Dohme, Novartis and UCB 
      Pharma; has been partly covered by some of these companies to attend previous 
      scientific meetings including the ERS (European Respiratory Society annual 
      congress) and the AAAAI (American Academy of Allergy Asthma and Immunology annual 
      meeting); and has participated in clinical research studies sponsored by 
      AstraZeneca, GlaxoSmithKline, Merck Sharpe and Dohme, and Novartis. PSB has 
      received lecture fees from AstraZeneca, GlaxoSmithKline and NycoMed; has 
      participated in clinical research studies sponsored by GlaxoSmithKline, Pfizer 
      and Boehringer Ingelheim; and is currently member of the Steering Committee and 
      the Scientific Committee of the ECLIPSE study, which is sponsored by 
      GlaxoSmithKline. LB has served as a consultant to and received lecture fees from 
      AstraZeneca, GlaxoSmithKline, Merck Sharpe and Dohme, Novartis and UCB Pharma; 
      has been partly covered by some of these companies to attend previous scientific 
      meetings including the ERS and the AAAAI; and has participated in clinical 
      research studies sponsored by AstraZeneca, GlaxoSmithKline, Merck Sharpe and 
      Dohme, and Novartis. SS has been sponsored by AstraZeneca, GlaxoSmithKline, 
      Boehringer Ingelheim/Pfizer to attend meetings and congresses including ATS 
      (American Thoracic Society annual meeting) and ERS; has participated in clinical 
      research studies sponsored by AstraZeneca, GlaxoSmithKline and Boehringer 
      Ingelheim; and has received lecture fees from GlaxoSmithKline and Boehringer 
      Ingelheim. CS-W, CC, LS, BH are employees of and hold stock in GlaxoSmithKline.
EDAT- 2012/01/24 06:00
MHDA- 2012/01/24 06:01
PMCR- 2012/01/19
CRDT- 2012/01/24 06:00
PHST- 2012/01/24 06:00 [entrez]
PHST- 2012/01/24 06:00 [pubmed]
PHST- 2012/01/24 06:01 [medline]
PHST- 2012/01/19 00:00 [pmc-release]
AID - bmjopen-2011-000370 [pii]
AID - 10.1136/bmjopen-2011-000370 [doi]
PST - epublish
SO  - BMJ Open. 2012 Jan 19;2(1):e000370. doi: 10.1136/bmjopen-2011-000370. Print 2012.