Inhaled Fluticasone Propionate by Diskus in the Treatment of Asthma

Purucker, Mary; Rosebraugh, Curtis J.; Feng, Zhou; Meyer, Robert J.

doi:10.1378/chest.124.4.1584

Cited by 33 publications

(2 citation statements)

References 10 publications

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“…With FP, a numerically higher increase in pre-dose FEV 1 with twice-daily dosing than with once-daily dosing was observed. The difference between once and twice daily FP was in line with differences previously reported for FP once versus twice daily [18,19], although this supports the current indication for twice-daily dosing of FP in asthma the study was not powered nor designed to assess differences between once-daily and twice-daily dosing of FP, only to assess differences between either FP dosing regimen and placebo. FF appears to be suitable for once-daily dosing as both once-daily and twice-daily dosing (same total daily dose) produced similar improvements in lung function,.…”

Section: Discussionsupporting

confidence: 80%

Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma

et al. 2011

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BackgroundInhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal. The objectives of this study were to compare the efficacy and safety of once-daily (OD) evening and twice-daily (BD) regimens of the novel inhaled corticosteroid fluticasone furoate (FF) in asthma patients.MethodsPatients with moderate asthma (age ≥ 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40-85% predicted; FEV1 reversibility of ≥ 12% and ≥ 200 ml) were randomized to FF or fluticasone propionate (FP) regimens in a double-blind, crossover study. Patients were not permitted to have used any ICS for ≥ 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 μg OD, FF or FP 100 μg BD and matching placebo by inhalation for 28 days each. Primary endpoint was Day 28 evening pre-dose (trough) FEV1; non-inferiority of FF 200 μg OD and FF 100 μg BD was assessed, as was superiority of all active treatment relative to placebo. Adverse events (AEs) and 24-hour urinary cortisol excretion were assessed.ResultsThe intent-to-treat population comprised 147 (FF) and 43 (FP) patients. On Day 28, pre-dose FEV1 showed FF 200 μg OD to be non-inferior (pre-defined limit -110 ml) to FF 100 μg BD (mean treatment difference 11 ml; 95% CI: -35 to +56 ml); all FF and FP regimens were significantly superior to placebo (p ≤ 0.02). AEs were similar to placebo; no serious AEs were reported. Urinary cortisol excretion at Day 28 for FF was lower than placebo (ratios: 200 μg OD, 0.75; 100 μg BD, 0.84; p ≤ 0.02).ConclusionsFF 200 μg OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose.Trial registrationClinicaltrials.gov; NCT00766090.

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Section: Discussionsupporting

confidence: 80%

Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma

et al. 2011

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“…In a previous 12-week study of FP dosed at 100 mg or 200 mg in ICS-naïve asthma patients FEV 1 was improved by 270 mL and 110 mL, respectively, compared with an 80 mL decline in the placebo group. 30,31 These findings suggest that the lack of efficacy observed with FP 100 mg twice-daily in this study resulted from the high placebo response, rather than a lack of efficacy with FP per se. There are a number of possible explanations for the high placebo response.…”

Section: Discussionmentioning

confidence: 68%