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

Haikarainen, Jussi; Selroos, Olof; Löytänä, Tero; Metsärinne, Sirpa; Happonen, Anita; Rytilä, Paula

doi:10.1007/s41030-016-0025-z

Cited by 17 publications

(33 citation statements)

References 25 publications

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“…In the other study comparing patient satisfaction with the use of Bufomix Easyhaler ® , patients who had previously used another pressure inhaler appreciated its easy preparation before inhalation and the ease of keeping it clean [ 21 ]. Also other studies confirm easy handling of Bufomix Easyhaler ® in the patients’ everyday life [ 4 , 11 , 13 , 22 – 24 ].…”

Section: Discussionmentioning

confidence: 57%

“…Better lung deposition of budesonide was shown for the Easyhaler ® dry powder inhaler in comparison with most pressurized metered-dose inhalers [ 3 ]. In vitro performance of Bufomix Easyhaler ® demonstrated its superiority over Symbicort Turbuhaler ® in reliability of dosing across a wide range of inspiratory flow rates, and its performance was not affected by environmental moisture, dropping, vibration, and freezing/thawing [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the Efficiency of Single-Inhaler Combination Therapy with Budesonide/Formoterol Fumarate in Patients with Bronchial Asthma in Daily Clinical Practice

Pirożyński

Hantulik²,

Almgren-Rachtan³

et al. 2017

Adv Ther

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IntroductionThe effectiveness of single-inhaler budesonide/formoterol fumarate combination therapy for asthma has been previously shown for the original product. The aim of this nonrandomized, open-label, postauthorization efficacy study (PAES) real-life clinical assessment was to evaluate the clinical effectiveness of a second product (Bufomix Easyhaler®) in the daily clinical practice of asthma therapy.MethodsThis multicenter PAES was conducted by 220 unselected allergologists and pulmonologists who enrolled 2200 adult outpatients (age 49.8 ± 17.9 years) with asthma treated with Bufomix Easyhaler® for at least 14 days before enrolment. Asthma control was assessed during three subsequent visits with 8–12-week intervals on the basis of the Asthma Control Test (ACT). Adherence was assessed with the Medication Adherence Questionnaire. In addition, patient satisfaction with Bufomix Easyhaler® was scored, and adverse drug reactions were recorded.ResultsThe percentage of patients with well-controlled asthma or total control of asthma (ACT score 20-25 points) increased from 46.6% at the first visit to 90.8% at the third visit (p < 0.001). In addition, the percentage of patients with poor control of asthma (ACT score less than 15 points) decreased from 14.9% to 1.2% (p < 0.001). The adherence rate increased from 88% at the first visit to 95.3% at the third visit. Patient satisfaction with the use of this dry powder inhaler increased with the duration of its use. Only one adverse drug reaction was reported.ConclusionThe results obtained confirm the effectiveness of Bufomix Easyhaler® in the treatment of asthma in outpatient adults in daily clinical practice.FundingOrion Corporation

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Section: Discussionmentioning

confidence: 57%

Section: Introductionmentioning

confidence: 99%

Evaluation of the Efficiency of Single-Inhaler Combination Therapy with Budesonide/Formoterol Fumarate in Patients with Bronchial Asthma in Daily Clinical Practice

Pirożyński

Hantulik²,

Almgren-Rachtan³

et al. 2017

Adv Ther

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“…Measurements of DD and FPD were performed as previously described. (5) Vibration. Vibration stress tests were performed according to International Electrotechnical Commission guidance on environmental testing IEC 60068-2-64:2008, (19) and as described by Haikarainen et al (5) Based on the standard, the inhalers were vibrated in the vertical axis for 60 minutes, using the following parameters: frequency range of 5-500 Hz, acceleration spectral density (ASD) level 1 m 2 /s 3 5-20 Hz, ASD level 3 decibels/octave 20-500 Hz, total spectral acceleration 0.9 g, and uncertainty of measurements 5%.…”

Section: Assessmentsmentioning

confidence: 99%

“…Moisture. The effect of moisture was assessed by placing inhalers (removed from their aluminum laminate pouch) under storage conditions of 30°C/75% relative humidity (RH) for 48 h. As per the methods described by Haikarainen et al, (5) DD and FPD were evaluated from the first 5 and 10 doses, respectively, before application of storage conditions; after storage, DD and FPD were analyzed from the next 5 and 10 doses in ambient laboratory conditions, respectively.…”

Section: Assessmentsmentioning

confidence: 99%

“…Freeze-thawing. Freeze-thawing was performed as previously described, (5) by placing inhalers (both within and removed from their aluminum laminate pouch simulating storage, transportation, and carrying inhaler) at -20°C (-5°C) for 2-3 days, before moving them to an elevated temperature (25°C -2°C) in an atmosphere of 60% -5% RH for 2-3 days, and repeating this for a total of three cycles. This process was carried out for 2 weeks, after which DD and FPD were subsequently analyzed and compared with those of reference inhalers not subjected to freeze-thawing, but that had been sealed inside their aluminum laminate pouch and kept at 25°C in an atmosphere of 60% RH for the same duration.…”

Section: Assessmentsmentioning

confidence: 99%

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Consistent Dosing Through the Salmeterol–Fluticasone Propionate Easyhaler for the Management of Asthma and Chronic Obstructive Pulmonary Disease: Robustness Analysis Across the Easyhaler Lifetime

Turpeinen

Eriksson

Happonen

et al. 2021

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Background: Easyhaler (registered trademark by Orion Corporation) is a multidose dry powder inhaler (DPI) for the treatment of asthma and chronic obstructive pulmonary disease (COPD), designed to be simple and easy to use. Salmeterol-fluticasone propionate (S-F) Easyhaler (50/250 and 50/500 lg per dose), available in several European countries, provides combined inhaled corticosteroid and long-acting beta agonist therapy for the management of asthma and COPD. A requirement of the European Committee for Medical Products for Human Use guidelines is to demonstrate product performance under conditions that mimic real-life patient use. Therefore, our aims were to assess the robustness of the S-F Easyhaler by assessing the delivered dose (DD) and fine particle dose (FPD) throughout the inhaler lifespan and under simulated environmental stress conditions. Methods: This was a noncomparative exploratory in vitro study. Two batches and six to nine inhalers per batch from both dose strengths were used to assess drug delivery performance over the inhaler lifespan (doses 1-60). For determining the impact of simulated environmental stress (tests for exposure of dropping, vibration, moisture, and freeze-thawing) on DD and FPD, one batch and three inhalers per batch from both dose strengths were used per test, respectively. Aerodynamic particle size distribution was evaluated during the simulated dropping and vibration tests. Results: DD and FPD from both dose strengths of S-F Easyhaler performance remained consistent through the inhaler lifespan and simulated environmental stress did not affect its performance. Similar DD and FPD values were observed with or without dropping, vibration, exposure to moisture, and freeze-thawing, and no inhaler breakages occurred during the simulated tests. Conclusions: The in vitro performance of S-F Easyhaler at both dose strengths suggests that reliable dosing and robustness can be achieved under real-life stress conditions; S-F Easyhaler is a durable DPI for the management of asthma and COPD.

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

Cited by 17 publications

References 25 publications

Evaluation of the Efficiency of Single-Inhaler Combination Therapy with Budesonide/Formoterol Fumarate in Patients with Bronchial Asthma in Daily Clinical Practice

Evaluation of the Efficiency of Single-Inhaler Combination Therapy with Budesonide/Formoterol Fumarate in Patients with Bronchial Asthma in Daily Clinical Practice

Consistent Dosing Through the Salmeterol–Fluticasone Propionate Easyhaler for the Management of Asthma and Chronic Obstructive Pulmonary Disease: Robustness Analysis Across the Easyhaler Lifetime

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

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