Dataset Information

Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK.

ABSTRACT:

Objectives

Budesonide/formoterol (BF) Spiromax ^® is an inhaled corticosteroid/long-acting ?₂-agonist fixed-dose combination (FDC) inhaler, designed to minimise common inhaler errors and provide reliable and consistent dose delivery in asthma and chronic obstructive pulmonary disease (COPD). We evaluated non-inferiority of BF Spiromax after changing from another FDC inhaler, compared with continuing the original inhaler.

Methods

Patients with asthma and/or COPD who switched to BF Spiromax were matched (1:3) with non-switchers. Data were obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink in the UK. The primary end point was the proportion of patients achieving disease control (using the risk domain control (RDC) algorithm); secondary end points were: exacerbation rate, short-acting ?₂-agonist (SABA) use and treatment stability (achieved RDC; no maintenance treatment change). Non-inferiority was defined as having 95% CI lower bound above -10%, using conditional logistic regression and adjusted for relevant confounders.

Results

Comparing 385 matched patients (asthma 253; COPD 132) who switched to BF Spiromax with 1091 (asthma 743; COPD 348) non-switchers, non-inferiority of BF Spiromax in RDC was demonstrated (adjusted difference: +6.6%; 95%?CI -0.3 to 13.5). Among patients with asthma, switchers to BF Spiromax versus BF Turbuhaler^® reported fewer exacerbations (adjusted rate ratio (RR) 0.76;95% CI 0.60 to 0.99; p=0.044); were less likely to use high daily doses of SABA (adjusted OR 0.71;95% CI 0.52 to 0.98; p=0.034); used fewer SABA inhalers (adjusted RR 0.92;95% CI 0.86 to 0.99; p=0.019); and were more likely to achieve treatment stability (adjusted OR 1.44;95% CI 1.02 to 2.04; p=0.037). No significant differences in these end points were seen among patients with COPD.

Conclusions

Among UK patients with asthma and COPD, real-world use of BF Spiromax was non-inferior to BF Turbuhaler in terms of disease control. Among patients with asthma, switching to BF Spiromax was associated with reduced exacerbations, reduced SABA use and improved treatment stability versus continuing on BF Turbuhaler.

SUBMITTER: Voorham J

PROVIDER: S-EPMC6224753 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Publications

Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK.

Voorham Jaco J Roche Nicolas N Benhaddi Hicham H van der Tol Marianka M Carter Victoria V van Boven Job F M JFM Bjermer Leif L Miravitlles Marc M Price David B DB

BMJ open 20181027 10

<h4>Objectives</h4>Budesonide/formoterol (BF) Spiromax <b><sup>®</sup></b> is an inhaled corticosteroid/long-acting β<sub>2</sub>-agonist fixed-dose combination (FDC) inhaler, designed to minimise common inhaler errors and provide reliable and consistent dose delivery in asthma and chronic obstructive pulmonary disease (COPD). We evaluated non-inferiority of BF Spiromax after changing from another FDC inhaler, compared with continuing the original inhaler.<h4>Methods</h4>Patients with asthma and ...[more]

PMID: 30368448

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Project description:IntroductionIn recognition of the value of long-term real-world data, a postauthorization safety study of the inhaled corticosteroid (ICS) fluticasone propionate and long-acting ?2-agonist (LABA) formoterol fumarate (fluticasone/formoterol; Flutiform®) was conducted.MethodsThis was a 12-month observational study of outpatients with asthma aged ? 12 years in eight European countries. Patients were prescribed fluticasone/formoterol according to the licensed indication, and independently of their subsequent enrolment in the study. They were then treated according to local standard practice. The study objectives were to evaluate the safety and effectiveness of fluticasone/formoterol under real-world conditions.ResultsThe safety population for this study comprised 2539 patients (mean age 47.7 years; 94.3% aged ? 18 years; 63.4% female). Most patients (1538/2539, 60.6%) had switched to fluticasone/formoterol from another ICS/LABA, primarily due to lack of efficacy (1150/2539, 45.3%). Three quarters (77.4%) of patients were treated for 12 months, and 80.6% continued fluticasone/formoterol treatment after the study. Adverse events (AEs) occurred in 60.0% patients, and 10.2% had AEs considered possibly related to fluticasone/formoterol [most commonly asthma exacerbation (2.0% patients), dysphonia (1.8%) and cough (1.1%)]. Thirty-six severe AEs, but no serious AEs, were considered possibly related to fluticasone/formoterol. The proportion of patients with controlled asthma (based on Asthma Control Test score ? 20) increased from 29.4% at baseline to 67.4% at study end (last observation carried forward). The proportion of patients experiencing at least one severe exacerbation decreased from 35.8% in the year prior to enrolment to 9.8% during the study. Improvements from baseline to study end were also observed in Asthma Quality of Life scores and physician/patient reports of satisfaction with treatment.ConclusionIn this real-world postauthorization safety study, fluticasone/formoterol demonstrated a safety profile consistent with that seen in controlled clinical trials, with effectiveness in improving asthma control.

Project description:BackgroundThe use of budesonide/formoterol in a single inhaler for both maintenance and reliever therapy is a recommended option for treatment of persistent asthma not responding well to inhaled corticosteroid (ICS) alone.MethodsThis was a multi-centre open-label study on patients whose asthma condition remained inadequately controlled by various asthma treatments other than budesonide/formoterol. After a 2-week run-in period, eligible patients underwent a 12-week treatment period with budesonide/formoterol (Symbicort SMART(®), 160/4.5 μg) twice daily plus as needed. Patient's asthma control and quality of life were assessed using the 5-item Asthma Control Questionnaire (ACQ-5) and the standardized Asthma Quality of Life Questionnaire (AQLQ-S), respectively.ResultsA total of 862 eligible asthma patients who have had asthma for a mean duration of 10.73 ± 12.03 years entered a 12-week treatment with budesonide/formoterol maintenance and reliever therapy. During treatment, ACQ-5 score improved significantly by 0.58 ± 0.93 (95% CI, 0.51 to 0.64, P < 0.0001) from the baseline level of 1.62 ± 1.00. AQLQ(S) score improved by 0.70 ± 0.89 (95% CI, 0.64 to 0.76, P < 0.0001) from baseline. Asthma symptom score was also reduced significantly (P < 0.0001); between run-in and treatment periods, night- and day-time symptom scores were reduced by 0.32 ± 0.54 (95% CI, 0.28 to 0.35) and 0.30 ± 0.52 (95% CI, 0.27 to 0.34), respectively. The percentage of nights with awakenings due to asthma symptoms was reduced by 11.09 ± 26.13% (95% CI, 9.34 to 12.85%), while the percentage of asthma-control and symptom-free days increased by 20.90 ± 34.40% (95% CI, 18.59 to 23.21%) and 23.89 ± 34.62% (95% CI, 21.56 to 26.21%), respectively (P < 0.0001). Together with the improvement in asthma control, the number of night- and day-time inhalations of as-needed reliever medication decreased by 0.30 ± 0.82 (95% CI, 0.24 to 0.35) inhalations and 0.30 ± 0.97 (95% CI, 0.23 to 0.36) inhalations, respectively (P < 0.0001). No unexpected adverse events were reported.ConclusionDuring treatment of inadequately controlled asthmatic patients with budesonide/formoterol maintenance and reliever therapy, significant improvement in patients' asthma control and reductions in asthma symptoms and as-needed medication use was observed. Patients' quality of life was improved and the treatment was well tolerated.Trial registrationClinicalTrial.gov: (NCT00939341).

Project description:IntroductionThe effectiveness of inhaled therapies can be influenced by many factors, including the type of inhaler, which may have clinical implications. We report a real-world, multicenter, open-label, non-randomized, non-interventional study conducted by 200 pulmonologists across 200 centers in Hungary. The effectiveness of budesonide/formoterol inhalation therapy in daily clinical practice, delivered via the Bufomix Easyhaler®, was evaluated in patients with asthma, chronic obstructive pulmonary disease (COPD) and asthma-COPD overlap (ACO).MethodsEffectiveness was assessed after 12 weeks of treatment by spirometry, the Asthma Control Test, mini-Asthma Quality of Life Questionnaire, COPD Assessment Test and modified Medical Research Council dyspnea scale. Patient satisfaction with the Bufomix Easyhaler® and physicians' assessments (ease of use and time taken to learn the technique) were also assessed.ResultsA total of 1498 patients with obstructive airway disease were evaluated (asthma: n = 621; COPD: n = 778; ACO: n = 99), of whom 455 (30.4%) were newly diagnosed inhaler-naïve patients and 1043 (69.6%) were switching from other inhalers. Significant improvements in lung function, disease control and health-related quality of life measures (all p ≤ 0.002) were reported after 12 weeks of Bufomix Easyhaler® use. Improvements were observed in both inhaler-naïve patients and those who switched to a Bufomix Easyhaler® from other devices. After switching, 72.4% of patients regarded the Bufomix Easyhaler® as 'very good' and > 90.0% of physicians described the Bufomix Easyhaler® as easy to teach; 73.8% and 98.9% of patients learned the technique within 5 and 10 min of teaching, respectively.ConclusionTwelve weeks' treatment with the Bufomix Easyhaler® resulted in significant improvements in disease control and quality of life. The Bufomix Easyhaler® was considered easy to use, and most patients were satisfied with the inhaler. Results confirm the real-world effectiveness of the Bufomix Easyhaler® in the treatment of adult outpatients with obstructive airway disease.FundingOrion Corp., Orion Pharma.

Project description:INTRODUCTION:Persistent symptoms, poor disease control, and reduced quality of life (QoL) are common in patients with asthma and chronic obstructive pulmonary disease (COPD). Current therapies are only partially effective and inhaler misuse contributes to insufficient disease control and poor outcomes. This real-world study aimed to evaluate the effectiveness of budesonide/formoterol fumarate (B/F) Easyhaler® in everyday clinical practice in Hungary. METHODS:Post hoc, subgroup analyses of this 12-week, real-world, multicenter, open-label study were conducted in adults diagnosed with asthma or COPD. Endpoints included the change in patient-reported outcome measures; i.e., symptoms and disease control measured by Asthma Control Test or COPD Assessment Test and health-related (HR)QoL measured by mini-Asthma Quality of Life Questionnaire or modified Medical Research Council dyspnea scale. Changes in lung function and patient satisfaction with B/F Easyhaler versus their previous inhaler were also evaluated. Results were stratified by the inhaler device used at visit 1 (baseline, when patients switched device); comparisons were made with B/F Easyhaler use after 12 weeks, assessed at visit 3. RESULTS:In total, 398 and 563 patients with asthma and COPD, respectively, were analyzed. Significant improvements (p < 0.0001) in symptoms and disease control, HRQoL, and lung function were reported 12 weeks after switching treatment to B/F Easyhaler from the most commonly used devices (≥ 10% of patients). Significant increases in patient satisfaction were also reported versus comparators. CONCLUSIONS:Patients with asthma or COPD who switched to B/F Easyhaler from their previous inhaler due to lack of disease control achieved significant improvements in symptoms and disease control, HRQoL, and lung function within 12 weeks of real-world use with significant increase in patient satisfaction also observed. Such comparative information may reassure clinicians and patients that may be viewed as an appropriate and potentially beneficial treatment option. TRIAL REGISTRATION NUMBER:OGYÉI/13942-5/2016 (National Pharmaceutical Institute of Pharmacy and Nutrition of Hungary). FUNDING:Orion Corporation, Orion Pharma. Plain language summary available for this article.

Project description:INTRODUCTION:In real-life practice, asthma remains poorly controlled, with a considerable burden on patients' quality of life. Budesonide/formoterol (B/F) Easyhaler® has demonstrated similar dose consistency, therapeutic equivalence, and equivalent bronchodilator efficacy to B/F Turbuhaler®, but no real-life comparisons are yet available in patients switching from B/F Turbuhaler® to B/F Easyhaler®. METHODS:The primary objective of this real-life, non-interventional, observational study was to show non-inferiority of asthma control when adult patients in Swedish primary care with persistent asthma switched from B/F Turbuhaler® to B/F Easyhaler®. At visit 1, baseline demographic and endpoint data were recorded, and eligible patients switched to B/F Easyhaler®. The study comprised a control visit (visit 2) and a concluding examination (visit 3) after 12 weeks. Asthma control was assessed using the Asthma Control Test (ACT). The mini-Asthma Quality of Life Questionnaire (AQLQ) and lung function test were performed, and participants and investigators answered questionnaires about ease-of-use and teaching. RESULTS:A total of 117 patients were enrolled in the on-treatment population; 81 (64.8%) were female. At visit 3, B/F Easyhaler® demonstrated non-inferiority to B/F Turbuhaler®; the mean difference in change from baseline ACT was statistically significant (18.9 vs. 20.7, respectively; p?<?0.0001) and met the non-inferiority criteria of B/F Easyhaler® being greater than - 1.5 points versus the reference product. Asthma was well controlled in 62 (53.0%) patients at baseline, increasing to 83 patients (70.9%) at visit 3. Patients experienced statistically significant improvements in mini-AQLQ score after B/F Easyhaler® treatment and lung function remained stable across the treatment period. B/F Easyhaler® was easy to learn and prepare for use. CONCLUSION:This real-life, non-interventional, non-inferiority study in adults with persist asthma demonstrates equivalent or better disease control when patients switch from B/F Turbuhaler® to B/F Easyhaler®. A further study with direct comparison between treatments could add to the understanding of inhaler switch. FUNDING:Orion Corporation, Orion Pharma.

Dataset Information

Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK.

Objectives

Methods

Results

Conclusions

Publications

Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK.

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