PMID- 23440247
OWN - NLM
STAT- MEDLINE
DCOM- 20130702
LR  - 20211021
IS  - 1468-3296 (Electronic)
IS  - 0040-6376 (Print)
IS  - 0040-6376 (Linking)
VI  - 68
IP  - 6
DP  - 2013 Jun
TI  - Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate 
      in combination with the beta2 agonist vilanterol administered once daily for 52 
      weeks in patients >=12 years old with asthma: a randomised trial.
PG  - 513-20
LID - 10.1136/thoraxjnl-2012-202606 [doi]
AB  - BACKGROUND: The inhaled corticosteroid fluticasone furoate (FF) in combination 
      with the long-acting beta2 agonist vilanterol (VI) is in development for asthma and 
      chronic obstructive pulmonary disease. OBJECTIVE: To assess the safety and 
      tolerability of FF/VI over 52 weeks in patients with asthma. METHODS: Patients 
      (aged >/=12 years; on inhaled corticosteroid) were randomised (2:2:1) to FF/VI 
      100/25 microg or FF/VI 200/25 microg once daily in the evening, or fluticasone propionate 
      (FP) 500 microg twice daily. Safety evaluations included adverse events (AEs), 
      non-fasting glucose, potassium, 24-h urinary cortisol excretion, ophthalmic 
      assessments, heart rate and pulse rate. RESULTS: On-treatment AEs were similar 
      across groups (FF/VI 66-69%; 73% FP). Oral candidiasis/oropharyngeal candidiasis 
      was more common with FF/VI (6-7%) than FP (3%). Twelve serious AEs were reported; 
      one (worsening hepatitis B on FP) was considered drug related. Statistically 
      significant cortisol suppression was seen with FP compared with both FF/VI groups 
      at Weeks 12 and 28 (ratios [95% CI] to FP ranged from 1.43 [1.11 to 1.84] to 1.67 
      [1.34 to 2.08]; p</=0.006), but not at Week 52 (ratios to FP were 1.05 [0.83 to 
      1.33] for FF/VI 100/25 microg and 1.09 [0.87 to 1.38] for FF/VI 200/25 microg). No 
      clinically important changes in non-fasting glucose, potassium, QT interval 
      corrected using Fridericia's formula (QTc[F]) or ophthalmic assessments were 
      reported. Pulse rate (10 min post dose [Tmax], Week 52) was significantly 
      increased with FF/VI versus FP (3.4 bpm, 95% CI 1.3 to 5.6; p=0.002 [FF/VI 100/25 
      microg]; 3.4 bpm, 95% CI 1.2 to 5.6; p=0.003 [FF/VI 200/25 microg]). Mean heart rate 
      (24-h Holter monitoring) decreased from screening values in all groups (0.2-1.1 
      bpm FF/VI vs 5 bpm FP; Week 52). CONCLUSIONS: FF/VI (100/25 microg or 200/25 microg) 
      administered once daily over 52 weeks was well tolerated by patients aged >/=12 
      years with asthma. The overall safety profile of FF/VI did not reveal any 
      findings of significant clinical concern. CLINICALTRIALS.GOV: NCT01018186.
FAU - Busse, William W
AU  - Busse WW
AD  - Department of Medicine, University of Wisconsin, Madison, WI, USA. 
      wwb@medicine.wisc.edu
FAU - O'Byrne, Paul M
AU  - O'Byrne PM
FAU - Bleecker, Eugene R
AU  - Bleecker ER
FAU - Lotvall, Jan
AU  - Lotvall J
FAU - Woodcock, Ashley
AU  - Woodcock A
FAU - Andersen, Leslie
AU  - Andersen L
FAU - Hicks, Wesley
AU  - Hicks W
FAU - Crawford, Jodie
AU  - Crawford J
FAU - Jacques, Loretta
AU  - Jacques L
FAU - Apoux, Ludovic
AU  - Apoux L
FAU - Bateman, Eric D
AU  - Bateman ED
LA  - eng
SI  - ClinicalTrials.gov/NCT01018186
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130225
PL  - England
TA  - Thorax
JT  - Thorax
JID - 0417353
RN  - 0 (Adrenergic beta-2 Receptor Antagonists)
RN  - 0 (Androstadienes)
RN  - 0 (Benzyl Alcohols)
RN  - 0 (Chlorobenzenes)
RN  - 0 (Glucocorticoids)
RN  - 028LZY775B (vilanterol)
RN  - JS86977WNV (fluticasone furoate)
SB  - IM
CIN - Thorax. 2013 Dec;68(12):1165. PMID: 23821392
CIN - Thorax. 2013 Dec;68(12):1165-6. PMID: 24204004
MH  - Administration, Inhalation
MH  - Adolescent
MH  - Adrenergic beta-2 Receptor Antagonists/*administration & dosage
MH  - Adult
MH  - Androstadienes/*administration & dosage
MH  - Asthma/*drug therapy/physiopathology
MH  - Benzyl Alcohols/*administration & dosage
MH  - Child
MH  - Chlorobenzenes/*administration & dosage
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Drug Tolerance
MH  - Female
MH  - Follow-Up Studies
MH  - Forced Expiratory Volume
MH  - Glucocorticoids/*administration & dosage
MH  - Humans
MH  - Male
MH  - Retrospective Studies
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC3664377
OTO - NOTNLM
OT  - Asthma
EDAT- 2013/02/27 06:00
MHDA- 2013/07/03 06:00
CRDT- 2013/02/27 06:00
PHST- 2013/02/27 06:00 [entrez]
PHST- 2013/02/27 06:00 [pubmed]
PHST- 2013/07/03 06:00 [medline]
AID - thoraxjnl-2012-202606 [pii]
AID - 10.1136/thoraxjnl-2012-202606 [doi]
PST - ppublish
SO  - Thorax. 2013 Jun;68(6):513-20. doi: 10.1136/thoraxjnl-2012-202606. Epub 2013 Feb 
      25.