Fluticasone Furoate/vilanterol Research Articles

Effect of fluticasone propionate/formoterol and fluticasone furoate/vilanterol on adolescents with chronic bronchial obstruction

BackgroundThe combination of inhaled corticosteroid and long-acting beta-agonist (ICS/LABA) has shown superiority in improving lung function (FEV1) compared with ICS. The clinical effect of ICS/LABA depends on the fine-particle fraction (FPF) and the pulmonary deposition. ObjectiveWe sought to compare the efficacy of two combinations of an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), fluticasone propionate/formoterol and fluticasone furoate/vilanterol, in asthmatic adolescents with chronic bronchial obstruction. MethodsFluticasone propionate/formoterol (FP/FORM) (125/5 μg 2 doses twice daily via the k-haler®) and fluticasone furoate/vilanterol (FF/VI) (92/22 μg once daily via the Ellipta®) were administered to adolescents aged 12 to 17 years who required regular anti-asthmatic medication and had a forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio below -1.65 SD in a 2-sequence, 16-week crossover trial. The primary efficacy end point was change in FEV1 compared to baseline. Secondary end points were FEV1/FVC, maximal expiratory flow at 50% of the forced vital capacity (MEF50), impulse oscillometry indices respiratory resistance at 5 Hz (R5), difference of R5 and R20 (R5−20), area of reactance (AX), and Asthma Control Test. ResultsBoth ICS/LABA combinations resulted in a significant improvement in FEV1 and MEF50 Z-scores without any significant difference between FP/FORM and FF/VI. Forty percent of patients achieved a normal prebronchodilator FEV1/FVC Z-score with either treatment. AX or R5−20 did not improve significantly with either treatment. ConclusionBoth ICS/LABA combinations demonstrated significant improvements in FEV1 Z-score. Over one-third of the asthmatic adolescents with prolonged bronchial obstruction achieved a normal prebronchodilator FEV1/FVC level.

Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea.

Fluticasone furoate/vilanterol (FF/VI; RELVAR ELLIPTA) is approved in Korea for patients with asthma or chronic obstructive pulmonary disease (COPD). This study evaluated the effectiveness and safety of FF/VI in Korean patients with asthma and/or COPD over a 6-year period. This was an open-label, multicentre, observational, post-marketing surveillance study in patients newly treated with FF/VI (100 or 200 μg/25 μg once daily). Safety endpoints were the incidence of adverse events (AEs), including unexpected AEs/adverse drug reactions (ADRs) and serious AEs/ADRs. Effectiveness was assessed after 24 weeks by Global Physician Assessment (logistic regression) and forced expiratory volume in 1 s (FEV1; paired t-tests). Of the 3426 patients enrolled across 45 hospitals between July 2014 and June 2020, 3216 were included in the safety analysis (50.5% female; mean age ± standard deviation [SD]: 58.6 ± 16.3 years). Overall incidence of AEs was 30.9% (n = 992); 4.1% (n = 132) were ADRs. Serious AEs were reported in 4.1% (n = 132) of patients; 0.1% (n = 4) were ADRs. Of 1543 patients analysed for symptomatic improvement, 89.2% (n = 1377) improved, 9.4% (n = 145) were unchanged, and 1.4% (n = 21) worsened. Mean FEV1 (difference ± SD) increased significantly in patients with asthma (0.09 ± 0.29 L; p < 0.0001), COPD (0.11 ± 0.24 L; p = 0.0011), or both (0.05 ± 0.18 L; p = 0.0399), indicating improved lung function. In this real-world study, FF/VI administered to Korean patients was well tolerated and effective for the treatment of asthma and COPD. These results were consistent with other studies in Asian and global populations.

Clinic vs Home Spirometry for Monitoring Lung Function in Patients With Asthma

Studies examining agreement between home and clinic spirometry in patients with asthma are limited, with conflicting results. Understanding the strengths and limitations of telehealth and home spirometry is particularly important considering the SARS-CoV-2 pandemic. How well do home and clinic measurements of trough forced expiratory volume in 1 second (FEV1) agree in patients with uncontrolled asthma? This post hoc analysis used trough FEV1 data from the randomised, double-blind, parallel-group Phase IIIA CAPTAIN (205715; NCT02924688) and Phase IIB (205832; NCT03012061) trials in patients with uncontrolled asthma. CAPTAIN evaluated the impact of adding umeclidinium (UMEC) to fluticasone furoate/vilanterol (FF/VI) via a single inhaler; 205832 investigated adding UMEC to FF versus placebo. Trough FEV1 measurements were collected via home spirometry and supervised in-person spirometry in the research clinic. To compare home and clinic spirometry, we examined the time-course analyses of home and clinic trough FEV1, and generated post hoc Bland-Altman plots to assess agreement between home and clinic spirometry. Data from 2436 (CAPTAIN) and 421 (205832) patients were analysed. Treatment-related improvements in FEV1 were observed in both trials using home and clinic spirometry. Improvements measured by home spirometry were of lower magnitude and less consistent than clinic measurements. Bland-Altman plots suggested poor agreement between home and clinic trough FEV1 at baseline and Week 24. This post hoc comparison of home and clinic spirometry is the largest conducted in asthma. Results showed that home spirometry was less consistent than and lacked agreement with clinic spirometry, suggesting that unsupervised home readings are not interchangeable with clinic measurements. However, these findings may only be applicable to home spirometry using the specific device and coaching methods employed in these studies. Post-pandemic, further research to optimise home spirometry use is needed. Clinicaltrials.gov (NCT03012061; NCT02924688).

Estimating individual treatment effects on COPD exacerbations by causal machine learning on randomised controlled trials

RationaleEstimating the causal effect of an intervention at individual level, also called individual treatment effect (ITE), may help in identifying response prior to the intervention.ObjectivesWe aimed to develop machine learning...

Fluticasone Furoate/Vilanterol Use Trends and Characteristics in Patients With Obstructive Airway Disease: A Real-World Study of 10,374 Patients From India.

Introduction Obstructive Airway Diseases (OADs) are the leading cause of death among chronic respiratory diseases worldwide, and novel therapies are direly needed. Fluticasone furoate/vilanterol (FF/Vi) (100/25 µg) is the first once-daily ICS/uLABA marketed in India for COPD since 2021. Considering its limited real-world experience in OAD patients in Indian clinical settings, a large drug utilization study (DUS) was planned. Methodology We conducted a cross-sectional, observational DUS at 1900 outpatient clinics in India from October 2021 to March 2022. Prescription data and medical history of patients who were prescribed the FF/Vi combination werecollected. Results It was observed that FF/Vi was prescribed in an almost equal number of patients with COPD (44.2%) and asthma (42.9%). The majority of the patients (74%) were switched from previous ICS/LABA to this ICS/uLABA, while 26% of patients were treatment naïve.The average CAT score was 19.5±7.8 (43.2% GOLD Group C and 32.2% GOLD Group B) in COPD patients, while the average ACQ-5 score was 2.6±1.3 (33.1% GINA Step 3, 29.5% GINA Step 2) in asthmatic patients. Most of the patients (63.9%) had raised biomarkers (Blood eosinophil count >300 cells/μl). Prior history of exacerbation was present in 65% of patients with annual exacerbation rates of 1.2 in COPD, 1.1 in asthma, and 1.2 in asthma-COPD overlap syndrome (ACOS). Leukotriene inhibitors (42%) and LAMAs (30.8%) were common add-on medications. Conclusion We observed a trend towards a shift to once-daily ICS/uLABA (FF/Vi) by physicians, especially in symptomatic and exacerbating OAD patients with underlying comorbidities.

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...

Cost-effectiveness analysis: fluticasone furoate/umeclidinium/vilanterol for the treatment of moderate to severe chronic obstructive pulmonary disease from the perspective of the Chilean public health system

ABSTRACT Background Chronic obstructive pulmonary disease (COPD) is an inflammatory lung disease characterized by long-term breathing problems and airflow limitations. International guidelines recommend using bronchodilators like long-acting beta- and muscarinic antagonists, and inhalational corticosteroids. Objectives The cost-effectiveness of single-inhaler triple therapy containing fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) was compared to the treatments Fluticasone Furoate/Vilanterol (FF/VI), Umeclidinio/Vilanterol (UMEC/VI) and Fluticasone Propionate 250 mcg/Salmeterol 25mcg + Tiotropio 18 mcg (FP/SAL/TIO) for patients with COPD from the Chilean public health system perspective. Methods A cost-effectiveness analysis was performed, including a deterministic and probabilistic sensitivity analysis over a 25-year time horizon. Two scenarios were assessed to study the effect of a 3%-discount for costs and outcomes on FF/UMEC/VI. Results The incremental cost-effectiveness (ICER) of FF/UMEC/VI versus FF/VI was $10,076/QALY, being a cost-effective alternative to a threshold of one Gross Domestic Product per capita (GDPpc), while versus FP/SAL/TIO the ICER increased to $50,288/QALY, showing to be a non-cost effective alternative to 1 GDPpc, but at a threshold of 3 GDPpc. Conclusion FF/UMEC/VI appears to be a cost-effective intervention for treating COPD compared to FF/VI. However, FF/UMEC/VI compared to FP/SAL/TIO showed an ICER above the threshold of 1 GDPpc, but, in comparison with lower price, the ICER was below 3 GDPpc.

Effects of switching from a metered dose inhaler to a dry powder inhaler on climate emissions and asthma control: post-hoc analysis

ObjectiveTo compare the effects of switching from a pressurised metered dose inhaler (pMDI)-based to a dry powder inhaler (DPI)-based maintenance therapy versus continued usual care on greenhouse gas emissions (carbon...

D010 CAPTAIN STUDY: EFFECTS OF BASELINE IGE LEVELS ON TRIPLE THERAPY RESPONSE IN INADEQUATELY CONTROLLED ASTHMA

CAPTAIN showed that adding umeclidinium (UMEC) to fluticasone furoate/vilanterol (FF/VI) improved lung function and symptom control in uncontrolled asthma; treatment response varied by baseline type-2 inflammatory biomarkers. As IgE may also influence treatment response, we evaluated the impact of adding UMEC and/or increasing FF dose in subgroups defined by baseline IgE levels.

Targeting the Small Airways with Inhaled Corticosteroid/Long-Acting Beta Agonist Dry Powder Inhalers: A Functional Respiratory Imaging Study.

Background: Peripheral deposition of inhaled medication is important as small airway disease has a key role in asthma. In this study, we compared the lung deposition at different mean flow rates of three inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) combinations delivered by dry powder inhaler (DPI), that is, Foster NEXThaler® (extrafine formulation of beclomethasone/formoterol), Relvar Ellipta® (fluticasone furoate/vilanterol trifenatate), and Symbicort Turbohaler® (budesonide/formoterol).Materials and Methods: In vitro drug delivery parameters were applied to lung computerized tomography (CT) scans of 20 asthma patients by functional respiratory imaging (FRI). Aerosol airway deposition patterns were calculated as percentage (standard deviation) intrathoracic versus extrathoracic deposition, percentage peripheral deposition, and central-to-peripheral (C/P) ratio at different inspiratory mean flow rates.Results: At 60 and 40 L/min, intrathoracic deposition of ICS/LABA was significantly higher with NEXThaler versus Ellipta. Peripheral deposition (60 L/min) with NEXThaler was higher than Ellipta for ICS (24.7% [3.5%] vs. 5.0% [2.0%]; p < 0.001) and LABA (25.3% [3.5%] vs. 13.0% [3.0%]; p < 0.001). C/P ratio with NEXThaler was lower (indicating higher peripheral deposition) than Ellipta (ICS: 0.63 vs. 1.63; LABA: 0.63 vs. 0.99). Inspiratory flow rate did not impact lung deposition with NEXThaler or Ellipta. In contrast, Turbohaler performance was negatively impacted by decreasing inspiratory flow rate. In fact, although lung deposition with Turbohaler was similar to that of NEXThaler at 60 L/min, lung deposition with Turbohaler was significantly lower than NEXThaler at both 40 L/min (∼30%) and 30 L/min (∼50%).Conclusions: Using FRI, we demonstrated better peripheral deposition and C/P ratios of ICS/LABA with NEXThaler versus Ellipta. NEXThaler demonstrated inspiratory flow rate independency of lung deposition versus Turbohaler. These findings suggest that the extrafine formulation is superior to large particle formulations in delivering ICS/LABA consistently both to the large and small airways.

Symptom control in patients with asthma using inhaled corticosteroids/long-acting β2-agonists (fluticasone furoate/vilanterol or budesonide/formoterol) in the US: a retrospective matched cohort study

Objective Treatment with fluticasone furoate/vilanterol (FF/VI), an inhaled corticosteroid/long-acting β2-agonist therapy, reduces the risk of severe asthma exacerbations and improves lung function and symptom control in patients with asthma. However, real-world data remain limited among asthma patients in the United States (US). Methods This retrospective cohort study propensity score (PS) matched adult asthma patients initiating once-daily FF/VI 100/25 mcg with patients initiating twice-daily budesonide/formoterol (B/F) 160/4.5 mcg using a US claims database (January 1, 2015–December 31, 2018). Asthma control was measured by the mean number of short-acting β2-agonist (SABA) canisters dispensed per patient-year (PPY) during follow-up. Time to first, and rates of, overall and severe asthma exacerbations were also measured. Results After PS matching, 18,531 patients receiving FF/VI were matched to 18,531 patients receiving B/F. Mean SABA canisters dispensed PPY was significantly lower for FF/VI users compared with B/F users (FF/VI: 1.47, B/F: 1.64; p < 0.001). FF/VI use resulted in 13% significantly lower risk of having an overall asthma-related exacerbation and 22% lower risk of a severe exacerbation versus B/F use (overall exacerbation hazard ratio [HR] [95% confidence interval (CI)]: 0.87 [0.82–0.92], p < 0.001; severe exacerbation HR [95% CI]: 0.78 [0.63–0.97], p = 0.027). Asthma-related exacerbation rates per 100 patient-days were also significantly lower for the FF/VI group compared with the B/F group (overall: 0.0475 vs. 0.0558, p < 0.001; severe: 0.0026 vs. 0.0033, p = 0.020). Conclusions In real-world practice, initiation of once-daily FF/VI 100/25 mcg in adults with asthma was associated with lower use of SABA and fewer asthma-related exacerbations, which may indicate better asthma control, when compared with use of twice-daily B/F 160/4.5 mcg.

Effect of Age on Efficacy and Safety of Fluticasone Furoate/Vilanterol (FF/VI), Umeclidinium (UMEC), and UMEC + FF/VI in Patients with Chronic Obstructive Pulmonary Disease: Analyses of Five Randomized Clinical Trials.

IntroductionConcerns have been raised about the practical use and clinical benefits of medications and inhalers in older patients with chronic obstructive pulmonary disease (COPD). Here, we report analyses according to age from five clinical trials evaluating medications administered using the ELLIPTA dry-powder inhaler (DPI).MethodsEfficacy and safety according to age groups (<65 and ≥65 years) were assessed using data from five clinical trials in patients ≥40 years of age with symptomatic COPD. There was a mix of pre-specified and post hoc analyses of two 24-week trials with fluticasone furoate (FF)/vilanterol (VI) 100/25 µg; one 24-week trial with umeclidinium (UMEC) 62.5 µg; and two 12-week trials with UMEC 62.5 µg + FF/VI 100/25 µg. The primary endpoint was trough forced expiratory volume in 1 second (FEV1) obtained 23 and 24 hours after dosing on the last day of the study.ResultsA total of 2876 patients <65 years of age and 2148 patients ≥65 years of age were enrolled across all studies of whom 1333 and 1111 patients, respectively, received treatment at the doses presented. Statistically significant and clinically meaningful treatment differences in improvement from baseline in mean trough FEV1 were reported for active comparators versus placebo at study end for both <65 and ≥65 years subgroups (FF/VI vs placebo: 143 mL and 111 mL; UMEC vs placebo: 110 mL and 123 mL; UMEC + FF/VI vs placebo + FF/VI: 136 mL and 105 mL; p<0.001 for all comparisons). The incidence of adverse events reported for active treatments was similar between age groups.ConclusionThese data provide evidence to support the use of FF/VI, UMEC, or UMEC + FF/VI, all delivered via the ELLIPTA DPI, to treat older (≥65 years) and younger (<65 years) patients with COPD.

CAPTAIN: Effects of Cardiovascular Risk on Response to Triple Therapy in Patients With Inadequately Controlled Asthma on Inhaled Corticosteroids/Long-acting β2-agonists (ICS/LABA)

In the CAPTAIN study, adding umeclidinium (UMEC) to fluticasone furoate/vilanterol (FF/VI) improved lung function and symptom control in patients with uncontrolled asthma. Here, we evaluate outcomes in subgroups defined by cardiovascular (CV) risk.

CAPTAIN: Effects of Body Mass Index (BMI) on Response to Triple Therapy in Patients With Inadequately Controlled Asthma on Inhaled Corticosteroids/Long-acting β2-agonists (ICS/LABA)

The CAPTAIN study showed that adding umeclidinium (UMEC) to fluticasone furoate/vilanterol (FF/VI) improved lung function and symptom control in uncontrolled asthma. As response to inhaled therapy may vary by bodyweight, we evaluated outcomes in CAPTAIN in subgroups defined by BMI.

The impact of fluticasone furoate/vilanterol on healthcare resource utilisation in the Salford Lung Study in chronic obstructive pulmonary disease.

Aim:The Salford Lung Study (SLS) in chronic obstructive pulmonary disease (COPD) was a randomised controlled trial evaluating the effectiveness and safety of initiating fluticasone furoate/vilanterol (FF/VI) 100/25 µg versus continuing usual care (UC) in patients with COPD and a history of exacerbations. Here, we investigate the impact of initiating FF/VI on healthcare resource utilisation (HRU) in SLS COPD.Methods:HRU and interventions were determined from patients’ electronic health records. Annual rates of on-treatment all-cause and COPD-related secondary care contacts (SCCs) and primary care contacts (PCCs) for FF/VI versus UC were analysed using a general linear model. Costs were derived from national data sources.Results:Least-squares (LS) mean annual rates of all-cause (9.81 versus 9.36) and COPD-related (1.57 versus 1.48) SCCs were similar for FF/VI and UC, as were rates of all-cause hospitalisations (0.87 versus 0.82). Mean duration of hospital stay/patient was 4.5 and 4.2 days, respectively. COPD-related SCC mean total cost/patient was £484 FF/VI and £475 UC. LS mean annual rates of all-cause PCCs were significantly higher for FF/VI (21.20 versus 18.88 UC; p < 0.001). LS mean annual rates of COPD-related PCCs were similar for FF/VI and UC (2.42 versus 2.46). All-cause PCC mean total cost/patient was £900 FF/VI versus £811 UC, but COPD-related PCC costs were similar (£116 versus £114). Direct COPD-related total medical costs/patient were significantly lower for FF/VI (LS geometric mean £806 versus £963 UC; p < 0.001).Discussion:In patients with COPD and exacerbation history, FF/VI may represent a less costly alternative to current therapies.GlaxoSmithKline plc. study HZC115151; ClinicalTrials.gov NCT01551758. The reviews of this paper are available via the supplemental material section.

Are the Global Initiative for Asthma (GINA) Guidelines Being Correctly Used to Diagnose Severe Asthma in the UAE?

ObjectivesWe aimed to identify the percentage inaccuracy in classifying asthma severity as severe asthma based on the 2019 Global Initiative for Asthma (GINA) guidelines criteria, at Cleveland Clinic Abu Dhabi, and make recommendations to improve the assessment of asthma severity.MethodsAll asthma patients that attended the Pulmonology clinic or the Allergy clinic from May 2015 to December 2019 were retrospectively analyzed to identify which asthma patients classified as having severe asthma according to the 2019 GINA guidelines criteria. We then calculated the percentage inaccuracy associated with giving diagnoses of severe asthma.ResultsWe retrospectively analyzed a total of 902 patients, and out of those, we identified 334 as patients with severe asthma according to the 2019 GINA guidelines criteria. Of those 334 patients, 218 were given an incorrect asthma severity of either mild (N=14), moderate (N=203), or unspecified asthma severity (N=1) in the hospital’s electronic records. This represents a percentage inaccuracy of 65.3% in classifying asthma severity as severe asthma. Fluticasone propionate-salmeterol was the most used ICS-LABA (inhaled corticosteroid and long-acting beta-agonist) medication in the severe asthma group (58.1%). Fluticasone furoate-vilanterol was identified as the most incorrectly prescribed ICS-LABA medication (68.2%).ConclusionWe identified an inaccuracy of 65.3% in classifying asthma severity as severe at our hospital. This inaccuracy is associated with a lack of understanding of the GINA guidelines by clinicians, as well as a lack of acceptance of some of the criteria in the GINA guidelines by patients. We have made recommendations to help improve the accuracy of asthma severity assessment, in order to be fully adherent to the GINA guidelines criteria.

M401 CHALLENGING CASES OF ASTHMATICS WITH COVID19 INFECTION

Introduction: We report 3 challenging cases of asthmatics, with COVID19, that elucidate the heterogeneity of presentation and disease progression Case Description: Our first case is a 66-year-old African American female managed on omalizumab, fluticasone furoate-vilanterol, montelukast, and tiotropium for moderate persistent asthma and allergic rhinitis She developed a fever of 102°°F, nonproductive cough, dyspnea, headache, and diarrhea Azithromycin initially improved her symptoms, but her cough and dyspnea relapsed, requiring hospital admission While inpatient, she was found to be COVID positive Management included IV hydration, hypokalemia management, and oxygenation via nasal cannula She was discharged after 9 days with all symptoms resolved save for mild to moderate dyspnea Second, we have a 47-year-old Hispanic female with allergic rhinitis and moderate persistent asthma managed on omalizumab, budesonide-formoterol, tiotropium, fluticasone, and montelukast She experienced a persistent cough, dyspnea, anosmia, ageusia, and an ongoing temperature > 100 4° °F She tested positive for COVID 19 and was started on prednisone 60 mg along with azithromycin Her dyspnea persisted so hydroxychloroquine was added to her regimen and her dyspnea resolved within 6 weeks Our final case is a 69-year Caucasian COVID19 positive female with mild persistent asthma and allergic rhinitis managed with montelukast She developed diarrhea, ear pain, anosmia, ageusia, weight loss, productive cough, and an average temperature of 101 9° °F She started azithromycin with symptom resolution by 14 days Discussion: In our experience, COVID19 infected asthmatics, with comorbid allergic rhinitis, all recovered between 14-42 days without developing pneumonia or acute respiratory distress syndrome

Successful Treatment of Allergic Bronchopulmonary Aspergillosis Using a Combination of Inhaled Fluticasone Furoate/Vilanterol and Oral Voriconazole

Systemic corticosteroids are considered to be the standard treatment for allergic bronchopulmonary aspergillosis (ABPA). However, there is controversy regarding use of inhaled corticosteroid (ICS) therapy for ABPA. Here we report a case of ABPA that was successfully treated with inhaled fluticasone furoate/vilanterol (FF/VI) and oral voriconazole (VRCZ). The patient was a 62-year-old Japanese man with bronchiectasis and diabetes mellitus who presented with fever, cough, and purulent sputum. Computed tomography scans of the chest showed consolidation in the left upper and lower lobes. Laboratory investigations revealed an abnormal increase in the number of eosinophils (3,340/mm 3 ) and elevated levels of C-reactive protein (3.04 mg/dL) and serum immunoglobulin E (IgE) (763 U/mL). Eight days after admission, he experienced a sudden attack of asthma. Aspergillus -precipitating antibodies were positive and Aspergillus fumigatus was detected in sputum culture. These results were consistent with a diagnosis of ABPA, and he was started on inhaled FF/VI and oral VRCZ. Systemic corticosteroids were not used because of the patient’s history of diabetes mellitus and left atrial thrombus. His symptoms and consolidation improved significantly after treatment. He has not experienced an exacerbation for more than 3 years. In mild cases of ABPA in which total IgE is relatively low, inhaled FF/VI in combination with oral VRCZ can be considered as an alternative treatment to systemic corticosteroids in patients with ABPA. J Med Cases. 2020;11(11):348-351 doi: https://doi.org/10.14740/jmc3567

Real-life effectiveness of fluticasone furoate/vilanterol after switching from fluticasone/salmeterol or budesonide/formoterol therapy in patients with symptomatic asthma: Relvar Ellipta for Real Asthma Control Study (RERACS study).

BackgroundThis study evaluated the efficacy of switching therapy from fluticasone propionate/salmeterol (FP/SM) or budesonide/formoterol (BD/FM) to fluticasone furoate and vilanterol (FF/VI) at the equivalent corticosteroid dose in a real-world setting.MethodsA prospective, 3-month, open-label, parallel group, switching therapy trial was performed in symptomatic asthma patients under routine management. Patients using 1 puff of FP 250 µg/SM 50 µg b.i.d or 2 puffs of BD 160 µg/FM 4.5 µg b.i.d were switched to FF 100 µg/VI 25 µg once daily, while patients using 1 puff of FP 500 µg/SM 50 µg b.i.d or 4 puffs of BD 160/FM b.i.d was switched to FF 200 µg/VI 25 µg once daily. The primary outcome was improvement of the predicted forced expiratory volume in 1 second % (%FEV1), while secondary outcomes were improvement of asthma symptoms evaluated by the asthma control test (ACT) and fractional exhaled nitric oxide (FeNO).ResultsThe %FEV1 was improved at 4 weeks after switching, and the improvement was maintained until 12 weeks. ACT also improved after switching. Patients with ACT <20 before switching showed greater improvement of symptoms at 4 weeks and 62% had an ACT score >20. FeNO decreased from 8 weeks.ConclusionsIn symptomatic asthma patients showing insufficient control, improvement of asthma was obtained by switching to FF/VI at the equivalent corticosteroid dose accompanied with the improvement of biomarkers. FF/VI can be a useful option for better control of asthma because of its high efficacy, long duration of action, and delivery via a single-action device.

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.