Evaluation of In Vitro and In Vivo Flow Rate Dependency of Budesonide/Formoterol Easyhaler®

Malmberg, L. Pekka; Everard, Mark L.; Haikarainen, Jussi; Lähelmä, Satu

doi:10.1089/jamp.2013.1099

Cited by 33 publications

(53 citation statements)

References 40 publications

(40 reference statements)

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“…Flow rate dependency of The Easyhaler and Turbuhaler inhalers was assessed with flow rate ranges achieved by the study patient population of an earlier study [3]. The minimum (10th percentile), median (50th percentile) and maximum (90th percentile) flow rates were used for DD and FPD measurements and are shown for both products in Table 1.…”

Section: Methodsmentioning

confidence: 99%

“…For the Easyhaler, the flow rates were 55.8 (13.0) L/min [standard deviations (SD)] in patients with COPD, 61.0 (11.1) L/min (SD) in asthmatic children, and 63.7 (11.5) L/min (SD) in adults with asthma. For the Turbuhaler, the corresponding mean values (SD) were 72.1 (15.1), 76.5 (14.1), and 79.4 (14.4) L/min [3]. An air flow resistance of 0.032 kPa 0.5 min/L was documented for the budesonide/formoterol Turbuhaler while the resistance for the budesonide/formoterol Easyhaler was 0.036 kPa 0.5 min/L [3].…”

Section: Introductionmentioning

confidence: 93%

“…For the Turbuhaler, the corresponding mean values (SD) were 72.1 (15.1), 76.5 (14.1), and 79.4 (14.4) L/min [3]. An air flow resistance of 0.032 kPa 0.5 min/L was documented for the budesonide/formoterol Turbuhaler while the resistance for the budesonide/formoterol Easyhaler was 0.036 kPa 0.5 min/L [3]. Thus, both the budesonide/formoterol Easyhaler and budesonide/formoterol Turbuhaler could be described as medium-resistance devices [5].…”

Section: Introductionmentioning

confidence: 98%

“…It has been previously shown that with clinically relevant flow rates, delivered doses (DD) and fine particle doses (FPD) are rather independent of flow rates with the budesonide/formoterol Easyhaler and budesonide/formoterol Turbuhaler [3], although in vitro flow-dependent properties of, e.g., the Turbuhaler have been reported [8]. However, the inspiratory effort may vary considerably from one patient to another and, thereby, potentially affecting the clinical efficacy of the product.…”

Section: Introductionmentioning

confidence: 99%

“…A previous study determined the mean inspiratory flow rates through the budesonide/formoterol Easyhaler and Turbuhaler in patients with COPD and in children and adults with asthma [3]. For the Easyhaler, the flow rates were 55.8 (13.0) L/min [standard deviations (SD)] in patients with COPD, 61.0 (11.1) L/min (SD) in asthmatic children, and 63.7 (11.5) L/min (SD) in adults with asthma.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Budesonide/Formoterol Easyhaler®: Performance Under Simulated Real-Life Conditions

Haikarainen

Selroos²,

Löytänä

et al. 2017

Pulm Ther

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 93%

Section: Introductionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Budesonide/Formoterol Easyhaler®: Performance Under Simulated Real-Life Conditions

Haikarainen

Selroos²,

Löytänä

et al. 2017

Pulm Ther

Self Cite

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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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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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Evaluation of In Vitro and In Vivo Flow Rate Dependency of Budesonide/Formoterol Easyhaler^®

Cited by 33 publications

References 40 publications

Budesonide/Formoterol Easyhaler®: Performance Under Simulated Real-Life Conditions

Budesonide/Formoterol Easyhaler®: Performance Under Simulated Real-Life Conditions

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

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

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