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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Int+J+Clin+Pharmacol+Ther
2015 ; 53
(9
): 753-64
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Pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol as a triple
therapy in healthy volunteers
#MMPMID26227101
Brealey N
; Gupta A
; Renaux J
; Mehta R
; Allen A
; Henderson A
Int J Clin Pharmacol Ther
2015[Sep]; 53
(9
): 753-64
PMID26227101
show ga
OBJECTIVE: Two single-center, four-way, single-dose, crossover studies assessed
the systemic exposure, systemic pharmacodynamics (PD), and safety profile of the
closed triple fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) therapy
compared with dual therapies. These are the first studies where pharmacokinetic
(PK) profile assessment was possible for this inhaled triple fixed-dose
combination product. METHODS: Healthy volunteers were randomized to receive 4
consecutive inhalations (each administered as a single dose) via a single ELLIPTŪ
dry powder inhaler: in study 1 (CTT116415/NCT01691547), FF/UMEC/VI at total doses
of 400/500/100 ?g, FF/UMEC 400/500 ?g, UMEC/VI 500/100 ?g, or FF/VI 400/100 ?g;
in study 2 (200587/NCT01894386), FF/UMEC/VI at total doses of 400/500/100 ?g or
400/250/100 ?g, FF/VI 400/100 ?g, or UMEC/VI 250/100 ?g. PK and PD parameters and
safety were assessed. RESULTS: Of 88 subjects, 95% completed both studies and
received all planned treatments. Total systemic exposure was similar for FF,
UMEC, and VI when administered as a triple therapy compared with FF/VI and
UMEC/VI. No clinically significant systemic PD findings were detected. The
incidence of adverse events was low and similar across treatment arms.
CONCLUSIONS: Systemic exposure to all three components of the closed triple
therapy, following single-dose delivery, was similar to that seen with the dual
therapies FF/VI and UMEC/VI. The delivered lung dose and safety profile of all
three agents, delivered via a single inhaler, are expected to be similar to those
of the dual therapies.
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