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

ABSTRACT: Inhaled 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.Patients 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 ?g OD, FF or FP 100 ?g 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 ?g OD and FF 100 ?g BD was assessed, as was superiority of all active treatment relative to placebo. Adverse events (AEs) and 24-hour urinary cortisol excretion were assessed.The intent-to-treat population comprised 147 (FF) and 43 (FP) patients. On Day 28, pre-dose FEV1 showed FF 200 ?g OD to be non-inferior (pre-defined limit -110 ml) to FF 100 ?g 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 ?g OD, 0.75; 100 ?g BD, 0.84; p ? 0.02).FF 200 ?g OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose.Clinicaltrials.gov; NCT00766090.

SUBMITTER: Woodcock A

PROVIDER: S-EPMC3282675 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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

Woodcock Ashley A Bleecker Eugene R ER Busse William W WW Lötvall Jan J Snowise Neil G NG Frith Lucy L Jacques Loretta L Haumann Brett B Bateman Eric D ED

Respiratory research 20111221

<h4>Background</h4>Inhaled 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.<h4>Methods</h4>Patients with moderate asthma (age ≥ 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40-85% predicted; FEV1 reversibil ...[more]

PMID: 22188590

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Project description:INTRODUCTION:There is a paucity of data describing prescribing patterns and adherence to therapy of inhaled corticosteroids (ICS) in combination with long-acting β2-agonists (LABA) in the Japanese population in clinical practice. METHODS:This was a non-interventional, retrospective, cohort study of patients who were prescribed medication for asthma, using data from the Japan Medical Data Center Claims Database. Data from patients aged ≥ 15 years with a prescription of asthma drugs between December 2014 and October 2015 (Day 0, the index date when asthma medication was initiated) were analysed in 12-month pre-index and post-index periods. Part 1 focused on baseline characteristics and epidemiological outcomes in the pre- and post-index period in the overall asthma population, whereas comparing medication adherence [number of prescribed days per year and proportion of days covered (PDC)] between ICS/LABA-naïve patients treated with once-daily fluticasone furoate/vilanterol (FF/VI) and twice-daily fluticasone propionate/salmeterol (FP/SAL) was the primary endpoint in Part 2. RESULTS:Of the available patient data (N = 2,953,652), 28,699 patients were identified as having asthma. ICS/LABA was the main asthma treatment prescribed; 11,167 (38.9%) patients were continuous ICS/LABA users. In ICS/LABA-naïve asthma patients, treatment with once-daily FF/VI was associated with higher medication adherence compared with twice-daily FP/SAL; mean [standard deviation (SD)] number of prescribed days per year was 97.8 (115.9) for FF/VI versus 80.5 (92.7) for FP/SAL (p = 0.04), mean (SD) PDC was 26.7% (31.5) for FF/VI versus 21.9% (24.8) for FP/SAL (p = 0.04). FF/VI was also associated with a lower rate of treatment discontinuation and no difference in use of short-acting beta2-agonists or oral corticosteroids compared with FP/SAL. CONCLUSIONS:ICS/LABA was the major prescribed asthma treatment in Japan. Medication adherence was greater with FF/VI, which may indicate that patients are more likely to adhere to once-daily FF/VI versus twice-daily FP/SAL. FUNDING:This study was funded by GSK (study sponsor). STUDY REGISTRATION:GSK Study No. 207264, GSK Study Register site: https://www.gsk-clinicalstudyregister.com/search/?search_terms=207264 .

Project description:Inhaled corticosteroids are a mainstay of therapy for persistent asthma, but suboptimal adherence with twice-daily use is widespread. Fluticasone furoate (FF) is a new inhaled corticosteroid (ICS) suitable for once-daily dosing in asthma. This study was performed to descriptively assess the efficacy and safety of two doses of FF, with no planned formal statistical hypothesis testing.This was a 24-week double-blind, multicentre, parallel-group study (NCT01431950). Patients aged ? 12 years with moderate-severe persistent asthma and uncontrolled on mid-high dose ICS were stratified by baseline FEV1 and randomised (1:1) to treatment with FF 100 ?g or 200 ?g once daily in the evening. The primary endpoint was change from baseline trough FEV1 after 24 weeks; secondary and other endpoints included peak expiratory flow (PEF) and rescue-free and symptom-free 24-hour periods over Weeks 1-24, and Asthma Control Test™ (ACT) score at Week 24. A pre-specified subgroup analysis of patients by randomisation strata was performed for the primary and selected secondary and other endpoints. Safety assessments included adverse events, laboratory and vital sign measurements, and change from baseline in 24-hour urinary cortisol at Week 24.With FF 100 ?g and 200 ?g, least squares mean trough FEV1 improved from baseline by 208 mL and 284 mL, respectively, at Week 24; treatment difference: 77 mL (95% CI: -39, 192). Similar improvements from baseline in rescue- and symptom-free periods, and morning and evening PEF were observed in both groups. Patients were 42% more likely to be well-controlled (ACT score ? 20) with FF 200 ?g than with FF 100 ?g. Slightly more patients receiving FF 200 ?g vs. FF 100 ?g reported adverse events (63% vs. 59%) and events deemed treatment related (5% vs. <1%). Seven serious adverse events (FF 200 ?g 4; FF 100 ?g 3) were reported, none of which were deemed treatment related. No clinically relevant effects of either dose on 24-hour urinary cortisol were observed.Improvements from baseline in trough FEV1 were observed after 24 weeks of treatment with both doses of FF, with a numerically greater improvement in FEV1 observed in patients receiving FF 200 ?g. Secondary endpoint findings were similar between groups. No safety concerns were identified during the study.

Project description:INTRODUCTION:The safety and efficacy of fluticasone furoate nasal spray (FFNS) for the symptoms of seasonal and perennial allergic rhinitis have been previously demonstrated in several clinical studies. The objective of this pilot study was to compare the efficacy and safety of FFNS 110 mcg once daily with placebo in patients with irritant (non-allergic) rhinitis triggered predominantly by air pollution. METHODS:This was a randomized, double-blind, placebo-controlled, 4-week study of subjects in Thailand with irritant rhinitis who received either FFNS 110 mcg (N=53) or placebo (N=49) once-daily. Subjects with a ?2 year history of air pollution as their predominant rhinitis trigger, negative skin test to local seasonal/perennial allergens, positive histamine skin test, and normal sinus radiograph were enrolled if they met minimum reflective total nasal symptom score (rTNSS) ?4.5 (maximum=9) and a nasal congestion score of ?2 (maximum =3). All were assessed for nasal eosinophilia at study entry and completion. Air quality was monitored throughout the study. The primary efficacy endpoint was the mean change from baseline over the treatment period in daily rTNSS, the average of the morning and evening rTNSS. The key secondary measure was the mean change from baseline over the entire treatment period in morning pre-dose instantaneous total nasal symptom score (iTNSS). RESULTS:The Air Quality Index (AQI) during the study generally did not reach unhealthy levels. Baseline daily rTNSS scores were similar between treatment groups (FFNS=6.7; placebo=6.4). The least square mean change from baseline in rTNSS was -2.17 and -2.10 for FFNS and placebo, respectively, with a difference of -0.065 (p=0.845). Gradual improvements were seen in both treatment groups for iTNSS; however, the treatment difference (-0.075) was not statistically significant (p=0.827). Additionally, there were no statistically significant differences between treatment groups for AM and PM rTNSS, individual nasal symptoms, daily reflective, AM and PM reflective and AM pre-dose instantaneous total ocular symptom scores (TOSS) or individual ocular symptom scores. Nasal cytology at baseline found more than two-thirds of subjects had <20% eosinophils. Adverse events were few and similar between groups and noted as mild in intensity. CONCLUSION:Subjects receiving FFNS had similar improvement to placebo in their rhinitis symptoms. The lack of a treatment effect may be in part due to the overall good air quality present throughout the study or an insufficient dose or duration of FFNS. The safety findings showed FFNS 110 mcg once daily to be well tolerated.

Dataset Information

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

Publications

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

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