Equivalent bronchodilation with budesonide/formoterol combination via Easyhaler and Turbuhaler in patients with asthma

Lähelmä, Satu; Vahteristo, Mikko; Metev, Hristo; Taseva, Margarita; Stamatova, Nadezhda; Bartha, Anna; Schlezák, Judit; Sairanen, Ulla

doi:10.1016/j.rmed.2016.09.016

Cited by 9 publications

(6 citation statements)

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“…This study used flow air rates collected from patients with asthma and chronic obstructive pulmonary disease (COPD) by Malmberg et al, who reported similar in vitro flow rate dependency compared with Turbuhaler ® [21]. Therapeutic equivalence and equivalent bronchodilator efficacy have also been reported between the two inhalers in pharmacokinetic and in vitro/in vivo correlation modeling studies [22], and equivalent bronchodilator efficacy was also demonstrated in a randomized, single-dose, four-period crossover study [23]. The real-life clinical effectiveness of B/F Easyhaler ® in the treatment of asthma in adult outpatients in routine daily clinical practice was also confirmed in non-randomized, open-label, single-arm studies conducted in Poland and Hungary [24, 25].…”

Section: Introductionmentioning

confidence: 99%

A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler® to Budesonide/Formoterol Easyhaler®

Syk

Vinge

Sörberg³

et al. 2019

Adv Ther

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IntroductionIn 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®.MethodsThe 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.ResultsA 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.ConclusionThis 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.FundingOrion Corporation, Orion Pharma.Electronic supplementary materialThe online version of this article (10.1007/s12325-019-00940-7) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler® to Budesonide/Formoterol Easyhaler®

Syk

Vinge

Sörberg³

et al. 2019

Adv Ther

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“…Additionally, superior dose consistency was observed compared with the Turbuhaler ® at different clinically relevant in vitro flow rates [ 19 ]. Therapeutic equivalence and equivalent bronchodilator efficacy have also been reported between the two inhalers [ 20 , 21 ].…”

Section: Introductionmentioning

confidence: 99%

Clinical Effectiveness of Budesonide/Formoterol Fumarate Easyhaler® for Patients with Poorly Controlled Obstructive Airway Disease: a Real-World Study of Patient-Reported Outcomes

Tamási

Szilasi

Gálffy³

2018

Adv Ther

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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.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0753-6) contains supplementary material, which is available to authorized users.

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“…In MART (Maintenance and Reliever Therapy), for patients with asthma treatment administered by a single inhaler, formoterol quickly reduces symptoms and contributes to achieve asthma control [31]. Budesonide-formoterol Easyhaler® has been shown to be bioequivalent with the reference product budesonideformoterol Turbuhaler® on both efficacy and safety [32,33]…”

Section: Equivalence Between Budesonide-formoterol Easyhaler and Turbuhalermentioning

confidence: 99%

The dry powder inhaler features of the Easyhaler that benefit the management of patients

Chrystyn

Lavorini

2020

Expert Review of Respiratory Medicine

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Introduction: Inhaled therapies are likely to continue to dominate asthma and chronic obstructive pulmonary disease treatment. Dry powder inhalers (DPIs) have several advantages over pressurized metered-dose inhaler (pMDIs), that are most frequently marketed world-wide, but often difficult to use. This literature search focus on DPI features, with respect to Easyhaler, that may affect their use and patients' clinical benefit. Areas covered: DPIs are breath-actuated, easy to use, convenient to use, and more environmentally friendly. During inhalation, the formulation in a DPI is disaggregated by a turbulent airflow energy to generate particles with the greatest likelihood of deposition into the airways. The resistance among DPIs varies from low to high and those with high resistance are wrongly considered as difficult to use. Multidose reservoir-type DPIs have been developed to efficiently deliver a wide range of medications, including the fixed-dose combination of budesonide and formoterol. Easyhaler® shares a similar shape with pMDIs and, as other DPIs, its performance is unaffected by environmental and storage conditions. Due to Easyhaler internal design, dose emission is consistent irrespective of the inhalation flow used by each patient. Expert opinion: Easyhaler® may be considered one of the most convenient inhalers, for daily use, in patients with asthma or COPD.

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Equivalent bronchodilation with budesonide/formoterol combination via Easyhaler and Turbuhaler in patients with asthma

Abstract: This trial was registered on ClinicalTrials.gov, Identifier: NCT02308098.

Cited by 9 publications

References 14 publications

A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler® to Budesonide/Formoterol Easyhaler®

A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler® to Budesonide/Formoterol Easyhaler®

Clinical Effectiveness of Budesonide/Formoterol Fumarate Easyhaler® for Patients with Poorly Controlled Obstructive Airway Disease: a Real-World Study of Patient-Reported Outcomes

The dry powder inhaler features of the Easyhaler that benefit the management of patients

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