Fluticasone Propionate/formoterol Research Articles

Treatment persistence and exacerbations in patients with asthma initiating treatment with inhaled corticosteroids and beta-adrenergic agonists: retrospective cohort study

ObjectiveTo determine treatment persistence and exacerbations in patients initiating inhaler treatment with fixed-dose combinations of inhaled corticosteroids/long-acting beta-2-adrenergic agonists (ICS/LABA) for the treatment of asthma.DesignRetrospective observational study conducted by review...

The comparison of fluticasone propionate/formoterol with fluticasone propionate/salmeterol for paediatric asthma: a meta-analysis of randomized controlled trials.

IntroductionThe comparison of fluticasone propionate/formoterol (FP/FORM) with fluticasone propionate/salmeterol (FP/SAL) for paediatric asthma remains controversial.AimWe conduct a systematic review and meta-analysis to explore the efficacy and safety of FP/FORM versus FP/SAL for paediatric asthma.Material and methodsWe have searched PubMed, Embase, Web of science, EBSCO, and Cochrane library databases through August 2019 for randomized controlled trials (RCTs) assessing the effect of FP/FORM versus FP/SAL for paediatric asthma. This meta-analysis is performed using the random-effects model.ResultsThree RCTs are included in the meta-analysis. Overall for paediatric asthma, FP/FORM and FP/SAL demonstrate a comparable influence on FEVj (Std. MD = -0.01; 95% CI: -0.04 to 0.03; p = 0.62), FVC (Std. MD = 0; 95% CI: -0.07 to 0.06; p = 0.87), FEF25 (Std. MD = -1.69; 95% CI: -6.69 to 3.31; p = 0.51), FEF50 (Std. MD = 0.10; 95% CI: -0.12 to 0.33; p = 0.37), FEF75 (Std. MD = 0.01; 95% CI: -0.21 to 0.24; p = 0.91), asthma symptom scores (Std. MD = -0.03; 95% CI: -0.11 to 0.04; p = 0.43), sleep disturbance scores (Std. MD = 0.03; 95% CI: -0.19 to 0.24; p = 0.81) and adverse events (RR = 1.07; 95% CI: 0.83 to 1.38; p = 0.61).ConclusionsFP/FORM and FP/SAL show a comparable efficacy for paediatric asthma.

The efficacy and safety of fluticasone propionate/formoterol compared with fluticasone propionate/salmeterol in treating pediatric asthma: a systematic review and meta-analysis.

ObjectiveTo evaluate the efficacy and safety of fluticasone propionate/formoterol (FP/FORM) versus fluticasone propionate/salmeterol (FP/SAL) in treating pediatric asthma during a 12-week treatment cycle.MethodsRandomized controlled trials of FP/FORM compared with FP/SAL in treating pediatric asthma were searched systematically using Medline, Embase, and the Cochrane Controlled Trials Register.ResultsTwo articles including 546 patients were evaluated. The FP/SAL group showed obvious improvements in pre-dose forced expiratory volume in 1 s (FEV1) from day 0 to 84, asthma symptom scores, and sleep disturbance scores compared with the FP/FORM group; however, the FP/FORM group had improved peak expiratory flow rate (PEFR). In terms of 2-hour post-dose FEV1 from day 0 to 84, 2-hour forced expiratory flow at 25%, 50%, and 75%, and 2-hour forced vital capacity, we observed no significant differences between the two groups. For safety, including patients with at least one adverse event, bronchitis, cough, or pharyngitis, both groups had similar incidences, differing only in incidence of nasopharyngitis.ConclusionCompared with FP/FORM, FP/SAL showed a clear improvement in pre-dose FEV1, asthma symptom scores, and sleep disturbance scores. However, FP/FORM resulted in improved PEFR with a lower incidence of nasopharyngitis.

PRS5 TREATMENT PERSISTENCE AND EXACERBATIONS IN PATIENTS WITH ASTHMA INITIATING TREATMENT WITH INHALED CORTICOSTEROIDS AND LONG-ACTING BETA-ADRENERGIC AGONISTS (ICS/LABA): REAL-LIFE STUDY

Asthma, a chronic inflammatory disease of the respiratory tract, presents with bronchial hyperresponsiveness and variable airflow obstruction. The objective of the study was to determine treatment persistence and exacerbations in patients initiating asthma treatment with various fixed-dose inhaled corticosteroid/long-acting beta-adrenergic agonist (ICS/LABA) combinations. An observational study was conducted by reviewing medical records. Patients aged ≥18 years were included who initiated treatment with ICS/LABA and met the inclusion/exclusion criteria. Patients were followed for one year. Study groups: fluticasone propionate/salmeterol (FP/SAL), beclomethasone/formoterol (BDP/FORM), budesonide/formoterol (BUD/FORM), fluticasone furoate/vilanterol (FF/VI) and fluticasone propionate/formoterol (FP/FORM). The main measurements were: treatment persistence, medication possession ratio (MPR) and exacerbations. Statistical significance was p <0.05. 3,203 patients were recruited, of which 31.1% were on FP/SAL, 28.6% BDP/FORM, 25.0% BUD/FORM, 8.2% FF/VI and 7.0% FP/FORM. The mean age was 52.2 years and 60.8% were female: 44.9% had moderate asthma. Treatment persistence was 61.7% (95% CI: 60.0-63.4%), and by study groups was: FP/SAL: 60.7%, BDP/FORM: 61.2 %, BUD/FORM: 60.3%, FF/VI: 66.7% and FP/FORM: 67.6% (p = 0.046). The MPR was: FP/SAL: 74.3%, BDP/FORM: 73.8%, BUD/FORM: 74.6%, FF/VI: 79.4% and FP/FORM: 80.6% (p = 0.028). The mortality rate was 2.9% and the percentage of exacerbations was: FP/SAL: 21.9%, BDP/FORM: 22.2%, BUD/FORM: 22.8%, FF/VI: 17.9% and FP/FORM: 16.0% (p = 0.036). Patients receiving FP/FORM and FF/VI had significantly greater treatment adherence (persistence, MPR) and lower rates of exacerbations. These differences could be due to the pharmacological properties of the drugs or other, unmeasured, factors.

PRS12 - A Budget Impact Analysis of The Inclusion of Fluticasone Propionate/Formoterol On A Government Subsidy List in Singapore For The Treatment of Moderate-To-Severe Asthma

A report by the Global Asthma Network (2014) ranked Singapore as an intermediate risk country for asthma prevalence. However, subsidy on asthma medication is limited to only a few selected inhaled corticosteroids and long-acting β2-agonists fixed dose combinations. The purpose of this model was to show the potential budgetary impact of the inclusion of fluticasone propionate/formoterol (FP/FORM) on a government subsidy list in Singapore, for treatment of patients with moderate-to-severe asthma. A budget impact model was built to show the change to annual drug costs for patients with moderate-to-severe asthma in Singapore following the inclusion of FP/FORM on a government subsidy list. The relevant prevalent population that requires treatment was identified, and the different treatment costs pertaining to this population were applied according to the market shares (IQVIA R03F Singapore National Sales Data) for different scenarios. The focus was on drug costs over five years, and publicly available non-subsidised patient prices obtained from pharmacies of local restructured hospitals were used in the model. An additional analysis was conducted examining the difference in exacerbation costs if uncontrolled patients were switched from fluticasone propionate/salmaterol (FP/SAL, Evohaler®) to FP/FORM. Assumptions based on published literature were validated by clinicians. The budget impact analysis showed that inclusion of FP/FORM on a government subsidy list, and the increase in market share as a result, could lead to drug cost savings of S$1,022,937 in the scenario where patients switch from FP/SAL (Evohaler®), and drug cost savings of S$2,561,917 in the scenario where patients switch from budesonide/formoterol (BUD/FORM, Turbuhaler®), over five years. Inclusion of FP/FORM on a government subsidy list in Singapore could lead to significant drug cost savings. FP/FORM is also associated with clinical benefits, such as low exacerbation rates, compared to FP/SAL and BUD/FORM, which could lead to further cost savings for uncontrolled asthma patients.

Fluticasone propionate/formoterol for COPD management: a randomized controlled trial.

PurposeTo evaluate fluticasone propionate/formoterol (FP/FORM) in COPD.Patients and methodsCOPD patients with forced expiratory volume in 1 s (FEV1) ≤50% predicted and ≥1 moderate/severe COPD exacerbation in the last 12 months were randomized to FP/FORM 500/20 or 250/10 µg bid, or formoterol (FORM) 12 µg bid for 52 weeks. The primary outcome was the annualized rate of moderate/severe COPD exacerbations.ResultsIn total, 1,765 patients were randomized. There were fewer discontinuations with FP/FORM 500/20 µg (20.6%) and 250/10 µg (24.0%) compared with FORM (26.1%). None of the two FP/FORM doses reduced the moderate/severe exacerbation rate versus FORM (rate ratios [RR]: 0.93; P≤0.402). There was a trend toward a lower moderate/severe exacerbation rate with FP/FORM 500/20 µg versus FORM in patients with ≥2 exacerbations in the preceding year (RR: 0.79; P=0.084). Pre- and post-dose FEV1 and forced vital capacity were greater with FP/FORM 500/20 µg versus FORM (P≤0.039). There was a trend toward a lower EXAcerbations of Chronic pulmonary disease Tool (EXACT) exacerbation rate with FP/FORM 500/20 µg versus FORM (RR: 0.87; P=0.077). There were more St George’s Respiratory Questionnaire for COPD (SGRQ-C) responders with FP/FORM 500/20 µg than FORM (odds ratios [OR] at weeks 6, 23 and 52 ≥1.28; P≤0.054). EXACT-respiratory symptoms total and breathlessness scores were lower with both FP/FORM 500/20 µg and 250/10 µg versus FORM (P≤0.066). Acute β2-agonist-induced effects and 24-hour Holter findings were similar for all treatments. Mean 24-hour urinary cortisol was similarly reduced with both FP/FORM doses. Radiologically confirmed pneumonia was seen in 2.4%, 3.2% and 1.5% of FP/FORM 500/20 µg, FP/FORM 250/10 µg and FORM-treated patients, respectively. Adverse events were otherwise similar across treatment groups.ConclusionFP/FORM did not reduce exacerbation rates versus FORM. Numerical benefits were observed with FP/FORM 500/20 µg versus FORM for secondary variables, including lung function, EXACT exacerbations, SGRQ-C and EXACT-respiratory symptoms total and breathlessness scores. Few efficacy differences were evident between FP/FORM 250/10 µg and FORM. Pneumonia was more frequent in FP/FORM-treated patients, although the absolute difference was low. Adverse events were otherwise similar between treatments.

Initiating or changing to a fixed-dose combination of Fluticasone propionate/Formoterol over Fluticasone propionate/Salmeterol: A real-life effectiveness and cost impact evaluation

ObjectiveAsthma has a substantial impact on quality of life and health care resources. The identification of a more cost-effective, yet equally efficacious, treatment could positively influence the economic burden of this disease. Fluticasone propionate/Formoterol (FP/FOR) may be as effective as Fluticasone Salmeterol (FP/SAL). We evaluated non-inferiority of asthma control in terms of the proportion of patients free from exacerbations, and conducted a cost impact analysis. MethodsThis historical, matched cohort database study evaluated two treatment groups in the Optimum Patient Care Research Database in the UK: 1) an FP/FOR cohort of patients initiating treatment with FP/FOR or changing from FP/SAL to FP/FOR and; 2) an FP/SAL cohort comprising patients initiating, or remaining on FP/SAL pMDI combination therapy. The main outcome evaluated non-inferiority of effectiveness (defined as prevention of severe exacerbations, lower limit of the 95% confidence interval (CI) of the mean difference between groups in patient proportions with no exacerbations is −3.5% or higher) in patients treated with FP/FOR versus FP/SAL. ResultsAfter matching 1:3, we studied a total of 2472 patients: 618 in the FP/FOR cohort (174 patients initiated on FP/FOR and 444 patients changed to FP/FOR) and 1854 in the FP/SAL cohort (522 patients initiated FP/SAL and 1332 continued FP/SAL). The percentage of patients prescribed FP/FOR met non-inferiority as the adjusted mean difference in proportion of no severe exacerbations (95%CI) was 0.008 (−0.032, 0.047) between the two cohorts. No other significant differences were observed except acute respiratory event rates, which were lower for patients prescribed FP/FOR (rate ratio [RR] 0.82, 95% CI 0.71, 0.94). ConclusionsChanging to, or initiating FP/FOR combination therapy, is associated with a non-inferior proportion of patients who are severe exacerbation-free at a lower average annual cost compared with continuing or initiating treatment with FP/SAL.

AB041. Effectiveness and cost impact evaluation of fluticasone propionate/formoterol compared to fluticasone propionate/salmeterol

Background Treatment of asthmatics with an inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) is recommended for maintenance treatment according to Step 3 in the GINA guidelines. Fixed-dose combination (FDC) inhalers simplify the dosing regimen and may improve adherence over their separate components. However, the effectiveness and cost impact of FDC devices containing fluticasone propionate/formoterol (FP/FOR) compared to fluticasone/salmeterol (FP/SAL) in asthma patients who initiate or switch to FDC ICS/LABA inhalers have not been studied in real-life patients in the United Kingdom. To determine whether FP/FOR is non-inferior to FP/SAL in patients who initiate or switch to a FDC ICS/LABA therapy with respect to decreasing the occurrence of asthma exacerbations and overall cost impact.

Combinación a dosis fija de fluticasona propionato/formoterol fumarato para el tratamiento del asma: una revisión de la farmacología, eficacia y tolerabilidad

The fixed-dose combination fluticasone propionate/formoterol (FPF) is a novel combination of a widely known and used inhaled glucocorticoid (IGC) and a long-acting β2-adrenergic agonist (LABA), available for the first time in a single device. This fixed-dose combination of FPF has a demonstrated efficacy and safety profile in clinical trials compared with its individual components and other fixed-dose combinations of IGC/LABA and is indicated for the treatment of persistent asthma in adults and adolescents. FPF is available in a wide range of doses that can adequately cover the therapeutic steps recommended by treatment guidelines, constituting a fixed-dose combination of GCI/LABA that is effective, rapid, well tolerated and with a reasonable acquisition cost. Various assessment agencies of the Spanish Autonomous Communities consider this combination to be an appropriate alternative therapy for asthma in the primary care setting.

Fluticasone-formoterol: a systematic review of its potential role in the treatment of asthma.

BackgroundThe purpose of this systematic review is to summarize and evaluate the available published data regarding the efficacy and safety of a combination product containing fluticasone propionate/formoterol (FP-F) in order to establish its potential role compared with other inhaled combination corticosteroid/long-acting beta2 receptor agonists for the maintenance treatment of asthma.MethodsA PubMed and EMBASE search was conducted using the terms “fluticasone propionate”, “formoterol fumarate”, “Flutiform®”, and “asthma” in July 2014 to identify trials using this combination specifically for the treatment of asthma. Additional information was gathered from references cited in the identified publications, the package insert, and the ClinicalTrials. gov registry. All randomized controlled clinical trials for humans in asthma were evaluated for inclusion. Data from animal trials, clinical trials for chronic obstructive pulmonary disease, and non-English sources were excluded.ResultsSeven short-term safety and efficacy trials of FP-F compared with its individual components and two comparison trials of FP-F versus other combination products were identified. Generally, the incidence of drug-related adverse events was low and consistent with previously reported drug class-related adverse events (ie, pharyngitis, dysphonia, and headache). The combination of FP-F was shown to be noninferior to fluticasone propionate/salmeterol for improving predose forced expiratory volume at one second (FEV1) and 2 hours post dose FEV1. FP-F was also noninferior to budesonide/formoterol in improving predose FEV1. Other clinical endpoints, including various symptom scores, asthma control, quality of life, and subjects’ assessment of the medications were not significantly different.ConclusionPoor asthma control is common. The data from short-term studies indicate that this inhaled corticosteroid and long-acting beta2 receptor agonist combination product is non-inferior to similar combination products available. As FP-F is available in different strengths, the corticosteroid dose can be titrated without changing devices. A potential advantage is that those with good technique, the same type of device could be used for both their controller and rapid relief inhaler medicines. The choice of this combination versus other similar products may be based primarily on cost.

Fine Particle Profile of Fluticasone Propionate/Formoterol Fumarate Versus Other Combination Products: the DIFFUSE Study

The efficacy of inhaled products is affected by the degree, and potentially the site, of drug particle deposition in the lungs. Lung deposition correlates with the fine particle fraction (FPF; the proportion of dose containing particles <5 μm in aerodynamic diameter). This in vitro study (defining fluticasone propionate/formoterol particulate size [DIFFUSE]) examined the effects of inhalation flow rate on the FPF of the fluticasone propionate/formoterol (FP/FORM) pMDI aerosol compared with three other inhaled corticosteroids/long-acting β2-agonist (ICS/LABA) combination therapies administered by either DPI or pMDI [fluticasone propionate/salmeterol (FP/SAL), budesonide/formoterol (BUD/FORM) and beclometasone dipropionate/formoterol (BDP/FORM)]. Aerodynamic particle size distribution was determined for each product using an 8-stage Andersen Cascade Impactor at two inhalation flow rates: 28.3 and 60.0 L/min. Fine particle dose (mass of dose <5.0 μm) and FPF were calculated as a percentage of the labeled dose for the LABA and ICS of each product at both flow rates. FP/FORM suspension aerosol provided a high and consistent FPF of approximately 40% for the ICS and LABA components at both flow rates. At 28.3 L/min, the FPF of each component of FP/FORM (41.2% and 39.2%) was greater than that of FP/SAL DPI (12.5% and 11.3%), BUD/FORM DPI (8.2% and 6.6%) and BDP/FORM pMDI (28.5% and 26.0%). At 60.0 L/min, the FPFs of the FP/FORM components (43.7% and 42.1%) were greater than those of FP/SAL (17.8% and 14.8%) and BUD/FORM (35.0% and 30.1%), and similar to those of BDP/FORM (43.0% and 39.5%). The FP/FORM suspension aerosol produced a high and consistent FPF of approximately 40% across both flow rates. The consistent FPF in vitro may be predictive of FP/FORM providing more consistent drug dosing in vivo, helping to counteract variable lung dose due to variation in inspiratory flow rate among patients and between a patient’s day-to-day or successive inhalation maneuvers.