TY - JOUR
T1 - Once-daily fluticasone furoate is efficacious in patients with symptomatic asthma on low-dose inhaled corticosteroids
AU - Bleecker, Eugene R.
AU - Bateman, Eric D.
AU - Busse, William W.
AU - Woodcock, Ashley
AU - Frith, Lucy
AU - House, Karen W.
AU - Jacques, Loretta
AU - Davis, Angela M.
AU - Haumann, Brett
AU - Lötvall, Jan
N1 - Funding Information:
We acknowledge all patients who took part in the study and all of the investigators at the 144 centers. The authors wish to acknowledge the contribution of Susan Tomkins, GlaxoSmithKline, in the statistical analysis of the data, and also Ann Allen, GlaxoSmithKline, who was the study pharmacokineticist and had a significant role in developing the pharmacokinetic component of the study protocol. Editorial support in the form of development of draft outline, development of manuscript first draft, editorial suggestions to draft versions of this paper, assembling tables and figures, collating author comments, copyediting, fact checking, referencing, and graphic services was provided by Geoff Weller and Lisa Moore at Gardiner-Caldwell Communications (Macclesfield, UK) and was funded by GlaxoSmithKline.
Funding Information:
Disclosures: E. R. Bleecker has served as a consultant to and received lecture fees from GlaxoSmithKline and has performed clinical trials for GlaxoSmithKline, which have been administered by his employer Wake Forest University Health Sciences. E. D. Bateman has served as a consultant to and received lecture fees from GlaxoSmithKline, and his institution has received remuneration for participation in clinical trials sponsored by GlaxoSmithKline. W. W. Busse has served as a consultant to AstraZeneca, Boehringer Ingelheim, Novartis, and TEVA; served on advisory boards for Amgen, Centocor, GlaxoSmithKline, Johnson & Johnson, Merck Sharpe and Dohme, and Pfizer; received lecture fees from Merck Sharpe and Dohme; and received research funding from AstraZeneca, Ception, GlaxoSmithKline, MedImmune and Novartis. J. Lötvall 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. A. Woodcock has served as consultant to Almirall, AstraZeneca, Chiesi, GlaxoSmithKline, Merck Sharpe and Dohme, Novartis, and Schering Plough; and has received lecture fees and research grants from GlaxoSmithKline . L. Frith, L. Jacques, and A. M. Davis are employees of and hold stock in GlaxoSmithKline. B. Haumann was employed by GlaxoSmithKline at the time this study was conducted and continues to hold stock in GlaxoSmithKline. K. W. House was employed by and held stock in GlaxoSmithKline.
PY - 2012/11
Y1 - 2012/11
N2 - Background: Fluticasone furoate (FF) is an inhaled corticosteroid (ICS) with 24-hour activity in development as a once-daily treatment for the long-term management of asthma. Objective: To assess the efficacy and safety of 4 doses of once-daily FF administered using a dry powder inhaler in patients (<12 years) with moderate asthma, uncontrolled on low-dose ICS (fluticasone propionate [FP] 200 μg/day or equivalent). Methods: This double-blind, placebo-controlled, dose-ranging study randomized 622 patients to 1 of 6 treatments: FF (100, 200, 300, or 400 μg) once daily in the evening, FP 250 μg twice daily (active control), or placebo for 8 weeks. The primary endpoint was the change from baseline in predose evening forced expiratory colume in 1 second (FEV1) at week 8. Results: At week 8, relative to placebo, all doses of FF once daily and FP twice daily demonstrated significantly (P <.001) greater increases from baseline and greater than 200-mL increases in predose FEV1. There was no evidence of a dose-response relationship between FF doses. Improvement with once-daily FF was similar to or greater than that for twice-daily FP. Secondary efficacy endpoint findings generally supported the efficacy of FF 100 to 400 μg once daily, although statistically significant improvements versus placebo in symptom-free 24-hour periods were only reported for FF 400 μg. There were few withdrawals due to lack of efficacy. Oral candidiasis was reported in 0 to 4% of patients; 24-hour urinary cortisol excretion ratios were similar across active treatment groups and not significantly different from placebo. Conclusion: FF 100 to 400 μg once daily in the evening is effective and well tolerated in patients with asthma uncontrolled on low-dose ICS, with 100 μg and 200 μg, considered the most applicable doses in this asthma population. Trial Registration: clinicaltrials.gov Identifier: NCT00603278.
AB - Background: Fluticasone furoate (FF) is an inhaled corticosteroid (ICS) with 24-hour activity in development as a once-daily treatment for the long-term management of asthma. Objective: To assess the efficacy and safety of 4 doses of once-daily FF administered using a dry powder inhaler in patients (<12 years) with moderate asthma, uncontrolled on low-dose ICS (fluticasone propionate [FP] 200 μg/day or equivalent). Methods: This double-blind, placebo-controlled, dose-ranging study randomized 622 patients to 1 of 6 treatments: FF (100, 200, 300, or 400 μg) once daily in the evening, FP 250 μg twice daily (active control), or placebo for 8 weeks. The primary endpoint was the change from baseline in predose evening forced expiratory colume in 1 second (FEV1) at week 8. Results: At week 8, relative to placebo, all doses of FF once daily and FP twice daily demonstrated significantly (P <.001) greater increases from baseline and greater than 200-mL increases in predose FEV1. There was no evidence of a dose-response relationship between FF doses. Improvement with once-daily FF was similar to or greater than that for twice-daily FP. Secondary efficacy endpoint findings generally supported the efficacy of FF 100 to 400 μg once daily, although statistically significant improvements versus placebo in symptom-free 24-hour periods were only reported for FF 400 μg. There were few withdrawals due to lack of efficacy. Oral candidiasis was reported in 0 to 4% of patients; 24-hour urinary cortisol excretion ratios were similar across active treatment groups and not significantly different from placebo. Conclusion: FF 100 to 400 μg once daily in the evening is effective and well tolerated in patients with asthma uncontrolled on low-dose ICS, with 100 μg and 200 μg, considered the most applicable doses in this asthma population. Trial Registration: clinicaltrials.gov Identifier: NCT00603278.
UR - http://www.scopus.com/inward/record.url?scp=84867529948&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84867529948&partnerID=8YFLogxK
U2 - 10.1016/j.anai.2012.08.017
DO - 10.1016/j.anai.2012.08.017
M3 - Article
C2 - 23062392
AN - SCOPUS:84867529948
VL - 109
SP - 353-358.e4
JO - Annals of Allergy, Asthma and Immunology
JF - Annals of Allergy, Asthma and Immunology
SN - 1081-1206
IS - 5
ER -