PMID- 17686110
OWN - NLM
STAT- MEDLINE
DCOM- 20071217
LR  - 20151119
IS  - 0105-4538 (Print)
IS  - 0105-4538 (Linking)
VI  - 62
IP  - 9
DP  - 2007 Sep
TI  - Long-term safety of fluticasone furoate nasal spray in adults and adolescents 
      with perennial allergic rhinitis.
PG  - 1071-7
AB  - BACKGROUND: Fluticasone furoate is a novel-enhanced affinity glucocorticoid and 
      its long-term safety must be assessed. This study was designed to assess the 
      safety and tolerability of 12-month intranasal administration of fluticasone 
      furoate in adult and adolescent patients with perennial allergic rhinitis (PAR). 
      METHODS: In this randomized, double-blind, placebo-controlled, parallel-group 
      study, 806 patients with PAR were randomized to once daily (od) fluticasone 
      furoate nasal spray 110 microg (n = 605) or vehicle placebo nasal spray (n = 201) 
      for 12 months, following a 7- to 14-day screening period. Safety was assessed by 
      monitoring adverse events (AEs), 24-h urinary cortisol excretion, nasal and 
      ophthalmic examinations, electrocardiograms and clinical laboratory tests. Plasma 
      concentrations of fluticasone furoate were determined from blood samples. 
      RESULTS: Fluticasone furoate was well tolerated. The incidence of most AEs was 
      similar to that observed with placebo, with the exception of epistaxis, which was 
      more frequently reported on active treatment. There were no clinically meaningful 
      differences between fluticasone furoate and placebo in terms of safety 
      assessments, including mean changes in ophthalmic parameters and 24-h urine 
      cortisol excretion. Plasma concentrations of fluticasone furoate were not 
      quantifiable in the majority of patients following intranasal administration. 
      CONCLUSIONS: Long-term (12-month) administration of fluticasone furoate 110 
      microg od revealed an AE profile typical of the intranasal corticosteroid class 
      in both adult and adolescent patients with PAR, with no evidence of clinically 
      relevant systemic corticosteroid exposure.
FAU - Rosenblut, A
AU  - Rosenblut A
AD  - Hospital Dr Sotero del Rio, Puente Alto, Santiago, Chile.
FAU - Bardin, P G
AU  - Bardin PG
FAU - Muller, B
AU  - Muller B
FAU - Faris, M A
AU  - Faris MA
FAU - Wu, W W
AU  - Wu WW
FAU - Caldwell, M F
AU  - Caldwell MF
FAU - Fokkens, W J
AU  - Fokkens WJ
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Denmark
TA  - Allergy
JT  - Allergy
JID - 7804028
RN  - 0 (Androstadienes)
RN  - 0 (Anti-Allergic Agents)
RN  - CUT2W21N7U (Fluticasone)
RN  - WI4X0X7BPJ (Hydrocortisone)
SB  - IM
MH  - Administration, Intranasal
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Androstadienes/*administration & dosage/*adverse effects/pharmacokinetics
MH  - Anti-Allergic Agents/*administration & dosage/*adverse effects/pharmacokinetics
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Fluticasone
MH  - Humans
MH  - Hydrocortisone/urine
MH  - Male
MH  - Middle Aged
MH  - Nebulizers and Vaporizers
MH  - Rhinitis, Allergic, Perennial/*drug therapy/urine
EDAT- 2007/08/10 09:00
MHDA- 2007/12/18 09:00
CRDT- 2007/08/10 09:00
PHST- 2007/08/10 09:00 [pubmed]
PHST- 2007/12/18 09:00 [medline]
PHST- 2007/08/10 09:00 [entrez]
AID - ALL1521 [pii]
AID - 10.1111/j.1398-9995.2007.01521.x [doi]
PST - ppublish
SO  - Allergy. 2007 Sep;62(9):1071-7. doi: 10.1111/j.1398-9995.2007.01521.x.