Clinical Equivalence of a Salmeterol/Fluticasone Propionate Combination Product (50/500??g) Delivered via a Chlorofluorocarbon-Free Metered-Dose Inhaler with the Diskus??? in Patients with Moderate to Severe Asthma

Noord, J.A. van; Lill, Hille; Díaz, T. Carrillo; Greefhorst, A.P.M.; Davies, Patricia

doi:10.2165/00044011-200121040-00002

Cited by 29 publications

(12 citation statements)

References 17 publications

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“…We selected as primary endpoint morning predose PEF, because PEF is easily performed and is a well-established outcome measure for monitoring asthma 1 for which clinically important treatment differences are recognized. 8,9 This was chosen in preference to a comprehensive measure of asthma control because, when the study was designed, the concept of using such measures was not well researched and their validity had not been established. The study was designed and powered for noninferiority of treatments, and rules for establishing superiority if noninferiority was demonstrated were also defined a priori.…”

Section: Discussionmentioning

confidence: 99%

“…The study was designed and powered for noninferiority of treatments, and rules for establishing superiority if noninferiority was demonstrated were also defined a priori. The noninferiority limit selected (95% lower CI bound of 215 L/min) has been used in previous studies, 8,9 and, in line with European clinical trial guidelines, 7 noninferiority had to be demonstrated in both ITT and PP populations before testing for superiority of a treatment in the ITT population. However, in the light of the recent emphasis and demonstrated benefits of using comprehensive composite measures of asthma control, 3,4,10,11 we also used control criteria very similar to those used in the GOAL study to examine the effects of dose reduction.…”

Section: Discussionmentioning

confidence: 99%

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Asthma control can be maintained when fluticasone propionate/salmeterol in a single inhaler is stepped down

Bateman

Jacques

Goldfrad

et al. 2006

Journal of Allergy and Clinical Immunology

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Asthma control can be maintained when fluticasone propionate/salmeterol in a single inhaler is stepped down

Bateman

Jacques

Goldfrad

et al. 2006

Journal of Allergy and Clinical Immunology

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“…Therefore, ASRMU diary data was reviewed from nine asthma clinical trials: six (Trials 1-6) [35][36][37][38][39][40] included salmeterol and fluticasone propionate combination therapy (FP/SAL) compared with salmeterol (SAL) and/or fluticasone propionate (FP) alone; two studies (Trials 7 and 8) included fluticasone furoate/vilanterol (FF/ VI) compared with FF alone [41,42]. One of the FF/VI studies also included a placebo arm [41] and the other study included an FP arm [42].…”

Section: Responsivenessmentioning

confidence: 99%

Measurement properties of an asthma symptom and rescue medication use diary

et al. 2014

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“…The non-inferiority margins used for the PEF analysis in this study, 12 l/min and 15 l/min, are well-established margins used in numerous previous studies and based upon European Medicines Agency guidelines [11, 23, 24]. For FEV 1 , the margins of 75 ml, 100 ml and 125 ml were chosen based upon the minimal clinically important difference (MCID) of 230 ml [13] and non-inferiority margins used in previous comparative studies involving FF/VI [6] or FF [25].…”

Section: Discussionmentioning

confidence: 99%

Once-daily fluticasone furoate/vilanterol versus twice daily combination therapies in asthma–mixed treatment comparisons of clinical efficacy

Svedsäter

Stynes

Wex

et al. 2016

asthma res and pract

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BackgroundFluticasone furoate (FF)/vilanterol (VI) is a once-daily inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) combination. FF/VI, 92/22mcg and 184/22mcg, are approved in Europe as maintenance therapy in persistent asthma. We report data from mixed treatment comparisons (MTC) of once-daily FF/VI against established twice-daily ICS/LABA combination therapies on clinical efficacy outcomes.MethodsData from 31 parallel-group randomised controlled trials (RCTs) of ICS/LABA, of ≥8 weeks’ duration in patients aged ≥12 years with asthma, identified by systematic review, were analysed using covariate-adjusted Bayesian hierarchical models for four efficacy outcomes (primary analysis). Lung function, assessed by change from baseline morning peak expiratory flow (PEF) (n = 18 studies) and forced expiratory volume in 1 s (FEV1) (n = 28), was the outcome of primary interest. Secondary objectives were assessment of relative efficacy in terms of exacerbation rates (n = 6) and health status (n = 7). Overall, 24 different treatment arms were included in the MTC; we report findings comparing FF/VI (92/22mcg and 184/22mcg) with fluticasone propionate/salmeterol (FP/SAL) (250/50mcg and 500/50mcg) and budesonide/formoterol (BUD/FORM) (320/9mcg and 640/18mcg).ResultsFor PEF (margin = 12 l/min), FF/VI 92/22mcg demonstrated ≥94 % probability and FF/VI 184/22mcg >99 % probability of non-inferiority to corresponding doses of both FP/SAL and BUD/FORM. For FEV1 (margin = 100 ml), FF/VI demonstrated ≥98 % (92/22mcg) and >99 % (184/22mcg) probability of non-inferiority to both FP/SAL and BUD/FORM. Findings for exacerbations were inconclusive due to lack of data: FF/VI 92/22mcg demonstrated 74 % and 82 % probability of non-inferiority (margin = 10 %) to FP/SAL 250/50mcg and BUD/FORM 320/9mcg, respectively. For Asthma Quality of Life Questionnaire (AQLQ) score, FF/VI 92/22mcg demonstrated >99 % and 90 % probability of non-inferiority (margin = 0.25) to FP/SAL 250/50mcg and BUD/FORM 320/9mcg. Data were unavailable to assess non-inferiority of FF/VI 184/22mcg on exacerbations or AQLQ.ConclusionsBoth strengths of once-daily FF/VI in asthma were comparable with corresponding doses of twice-daily FP/SAL and BUD/FORM in terms of lung function in this MTC analysis. FF/VI 92/22mcg was comparable with FP/SAL and BUD/FORM on AQLQ, but exacerbation results were inconclusive. Model limitations include disconnected treatment networks and variability across studies. Our data support previous RCT findings suggesting that the efficacy of once-daily FF/VI in improving lung function and health status in asthma is comparable with twice-daily ICS/LABAs.Electronic supplementary materialThe online version of this article (doi:10.1186/s40733-015-0016-0) contains supplementary material, which is available to authorized users.

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Clinical Equivalence of a Salmeterol/Fluticasone Propionate Combination Product (50/500??g) Delivered via a Chlorofluorocarbon-Free Metered-Dose Inhaler with the Diskus??? in Patients with Moderate to Severe Asthma

Cited by 29 publications

References 17 publications

Asthma control can be maintained when fluticasone propionate/salmeterol in a single inhaler is stepped down

Asthma control can be maintained when fluticasone propionate/salmeterol in a single inhaler is stepped down

Measurement properties of an asthma symptom and rescue medication use diary

Once-daily fluticasone furoate/vilanterol versus twice daily combination therapies in asthma–mixed treatment comparisons of clinical efficacy

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