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Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial.

O'Byrne PM, Woodcock A, Bleecker ER, Bateman ED, Lötvall J, Forth R, Medley H, Jacques L, Busse WW - Respir. Res. (2014)

Bottom Line: There was also a significant difference in rescue-free 24-h periods (11.6%; p = 0.004) vs. placebo.There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints.The incidence of adverse events was lower with FF (31%) than with placebo (38%); few were treatment-related (FF 50 mcg: n = 1, <1%; placebo: n = 4, 3%).

View Article: PubMed Central - PubMed

Affiliation: Michael G DeGroote School of Medicine, Hamilton, ON, Canada. obyrnep@mcmaster.ca.

ABSTRACT

Background: Fluticasone furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy.

Methods: This 12-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study randomized 248 patients (aged ≥12 years) to once-daily FF 50 mcg administered via the ELLIPTA™a dry powder inhaler or placebo. The primary endpoint was change from baseline in pre-dose evening trough forced expiratory volume in one second (FEV1). Secondary endpoints were change from baseline in percentage of rescue-free 24-h periods (powered), evening and morning peak expiratory flow, symptom-free 24-h periods and withdrawals due to lack of efficacy. Other endpoints included Asthma Control Test™, Asthma Quality of Life Questionnaire and ELLIPTA ease of use questions. Safety was assessed throughout the study.

Results: There was a significant difference in evening trough FEV1 between FF 50 mcg and placebo (treatment difference: 120 mL; p = 0.012). There was also a significant difference in rescue-free 24-h periods (11.6%; p = 0.004) vs. placebo. There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints. The incidence of adverse events was lower with FF (31%) than with placebo (38%); few were treatment-related (FF 50 mcg: n = 1, <1%; placebo: n = 4, 3%).

Conclusion: FF 50 mcg once daily significantly improved FEV1 and percentage of rescue-free 24-h periods experienced over 12 weeks vs. placebo, and was well tolerated.

Trial registration: www.clinicaltrials.gov, registration number: NCT01436071.

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Related in: MedlinePlus

Patient disposition.aMain reason was patients did not meet inclusion/exclusion criteria: 151(34%); bmain reason was patients did not meet continuation criteria: 36(8%); AE = adverse event; FF = fluticasone furoate; ITT = intent-to-treat; OD = once daily; PP = per protocol.
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Fig1: Patient disposition.aMain reason was patients did not meet inclusion/exclusion criteria: 151(34%); bmain reason was patients did not meet continuation criteria: 36(8%); AE = adverse event; FF = fluticasone furoate; ITT = intent-to-treat; OD = once daily; PP = per protocol.

Mentions: Of 449 patients screened, 248 were randomized, of whom 242 comprised the safety population and 222 comprised the ITT population. Within the ITT population, 90 (81%) placebo and 100 (90%) FF 50 mcg patients completed the study (Figure 1). Mean age, percentage of female patients and screening/baseline characteristics of lung function were similar between treatment groups (Table 1), with a baseline mean% predicted FEV1 of 81.58% in the ITT population. The majority of patients were of Hispanic/Latino ethnicity (73% placebo; 64% FF 50 mcg). Overall compliance with study medication (measured during the study using the dose counter on the DPI) was high and similar between treatment groups, at 97.7% in the placebo group and 99.0% in the FF 50 mcg group.Figure 1


Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial.

O'Byrne PM, Woodcock A, Bleecker ER, Bateman ED, Lötvall J, Forth R, Medley H, Jacques L, Busse WW - Respir. Res. (2014)

Patient disposition.aMain reason was patients did not meet inclusion/exclusion criteria: 151(34%); bmain reason was patients did not meet continuation criteria: 36(8%); AE = adverse event; FF = fluticasone furoate; ITT = intent-to-treat; OD = once daily; PP = per protocol.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4256920&req=5

Fig1: Patient disposition.aMain reason was patients did not meet inclusion/exclusion criteria: 151(34%); bmain reason was patients did not meet continuation criteria: 36(8%); AE = adverse event; FF = fluticasone furoate; ITT = intent-to-treat; OD = once daily; PP = per protocol.
Mentions: Of 449 patients screened, 248 were randomized, of whom 242 comprised the safety population and 222 comprised the ITT population. Within the ITT population, 90 (81%) placebo and 100 (90%) FF 50 mcg patients completed the study (Figure 1). Mean age, percentage of female patients and screening/baseline characteristics of lung function were similar between treatment groups (Table 1), with a baseline mean% predicted FEV1 of 81.58% in the ITT population. The majority of patients were of Hispanic/Latino ethnicity (73% placebo; 64% FF 50 mcg). Overall compliance with study medication (measured during the study using the dose counter on the DPI) was high and similar between treatment groups, at 97.7% in the placebo group and 99.0% in the FF 50 mcg group.Figure 1

Bottom Line: There was also a significant difference in rescue-free 24-h periods (11.6%; p = 0.004) vs. placebo.There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints.The incidence of adverse events was lower with FF (31%) than with placebo (38%); few were treatment-related (FF 50 mcg: n = 1, <1%; placebo: n = 4, 3%).

View Article: PubMed Central - PubMed

Affiliation: Michael G DeGroote School of Medicine, Hamilton, ON, Canada. obyrnep@mcmaster.ca.

ABSTRACT

Background: Fluticasone furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy.

Methods: This 12-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study randomized 248 patients (aged ≥12 years) to once-daily FF 50 mcg administered via the ELLIPTA™a dry powder inhaler or placebo. The primary endpoint was change from baseline in pre-dose evening trough forced expiratory volume in one second (FEV1). Secondary endpoints were change from baseline in percentage of rescue-free 24-h periods (powered), evening and morning peak expiratory flow, symptom-free 24-h periods and withdrawals due to lack of efficacy. Other endpoints included Asthma Control Test™, Asthma Quality of Life Questionnaire and ELLIPTA ease of use questions. Safety was assessed throughout the study.

Results: There was a significant difference in evening trough FEV1 between FF 50 mcg and placebo (treatment difference: 120 mL; p = 0.012). There was also a significant difference in rescue-free 24-h periods (11.6%; p = 0.004) vs. placebo. There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints. The incidence of adverse events was lower with FF (31%) than with placebo (38%); few were treatment-related (FF 50 mcg: n = 1, <1%; placebo: n = 4, 3%).

Conclusion: FF 50 mcg once daily significantly improved FEV1 and percentage of rescue-free 24-h periods experienced over 12 weeks vs. placebo, and was well tolerated.

Trial registration: www.clinicaltrials.gov, registration number: NCT01436071.

Show MeSH
Related in: MedlinePlus