Clinical Equivalence Trial on Budesonide Delivered either by the Novolizer&lt;sup&gt;®&lt;/sup&gt; Multidose Dry Powder Inhaler or the Turbuhaler&lt;sup&gt;®&lt;/sup&gt; in Asthmatic Patients

Ag, Chuchalin; Kremer, Hans-Joachim; Metzenauer, P.; O'Keefe, Emily; Hermann, Róbert

doi:10.1159/000066461

Cited by 20 publications

(11 citation statements)

References 14 publications

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“…Median FEV 1 increased by 310 ml in the present PMS. This value corresponds well with results obtained in a clinical study on this budesonide MDPI [4,5,8]. The MDPI system and its control mechanisms were well accepted.…”

Section: Discussionsupporting

confidence: 89%

“…With regard to clinical outcomes, in previous studies [4,5,8] the novel budesonide MDPI was proven to be equally effective in comparison to inhalative corticosteroid therapy using the reference budesonide MDPI. Based on the results of the present PMS which confirms the clinical efficacy of the novel budesonide MDPI together with the relevance and efficacy of the new control functions, this MDPI may be considered as a highly competitive device in comparison to the majority of available inhalation systems.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, it comprises a multiple inhalation control system: optical, acoustic and sensory control mechanisms confirm the correct inhalation of each single budesonide dose, provided the patient has triggered a valve system with a minimum inspiratory flow rate of 35 l/min which also induces a reset of the metering system [2]. This MDPI has been shown to achieve a high in vivo lung deposition [3], to be efficient and well tolerated in patients with bronchial asthma, and to have a high patient acceptance [4,5]. Patient satisfaction and acceptance are important factors in asthma therapy, as they influence the patient's compliance and therapeutic response [6,7].…”

Section: Introductionmentioning

confidence: 99%

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Improvement of Asthma Therapy by a Novel Budesonide Multidose Dry Powder Inhaler

Möller¹,

Fritsche

Rivera

et al. 2011

Arzneimittelforschung

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The objective of the present post-marketing surveillance (PMS) was the evaluation of efficacy, tolerability and acceptance of the novel budesonide (CAS 51333-22-3) multidose dry powder inhaler (MDPI) Novopulmon 200 Novolizer. A total of 3,057 patients suffering from allergic, non-allergic or mixed bronchial asthma were included in the PMS. The study medication was administered by inhalation at a median dosage of 2 x 200 micrograms budesonide/day. In order to evaluate the efficacy of the novel budesonide MDPI, pulmonary functions (peak expiratory flow rate (PEFR) and FEV1) were measured at the start of the treatment and after 4 weeks of treatment. Severity of the following symptoms was evaluated on a four-score scale: cough, wheezing, diurnal dyspnea, nocturnal dyspnea and dyspnea on physical effort. Furthermore, the patients' satisfaction in dealing with the control mechanisms (optical, acoustic, sensory, dose counter, overdose prevention) of this innovative MDPI was assessed. Patients who already had used another inhalation system assessed the control mechanisms of the novel budesonide MDPI in comparison with their previous inhalation system (e.g. fluticasone premetered dose MDPI, non-refillable budesonide MDPI). The patients' compliance and any improvement of compliance by the control mechanisms according to physicians' assessments were evaluated. The novel budesonide MDPI was shown to lead to a decrease in the severity of symptoms. The median total symptom score (0 = no symptoms, 15 = all symptoms severe) decreased from 8 before therapy to 2 after therapy. Pulmonary function measurements supported a relief of the patients' symptoms: The median PEFR increased from 5 l/s before therapy to 6.3 l/s at the end of therapy, with a median individual increase of 1 l/s. The median FEV1 increased from 2250 ml before therapy to 2700 ml at the end of therapy, with a median individual increase of 310 ml. The majority of patients were satisfied with the control mechanisms. 97% of the patients were satisfied with the optical control mechanism, 94% with the acoustic, 78% with the sensory mechanism, 92% with the dose counter and 81% with the overdose prevention. Compliance was assessed by the physicians to be good in 84% of the patients, to be satisfactory in 14% and to be not satisfactory in 2%. An improvement in compliance by the control mechanisms of the inhaler was observed in 80% of the patients. 97% of the patients were satisfied with the control mechanisms, the optical and acoustic mechanisms were confirmed as being the most important ones. The vast majority of patients assessed the control mechanisms of the novel MDPI to be better or much better than those of a previously used inhaler (e.g. 41.2% and 52.1%, respectively, of patients who had previously used a non-refillable budesonide MDPI; 38.7% and 44.7%, respectively, of patients who had previously used a fluticasone premetered dose MDPI). Overall, the novel budesonide MDPI was shown to be efficient in the relief of asthma symptoms and improvement of lung function. Th...

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Improvement of Asthma Therapy by a Novel Budesonide Multidose Dry Powder Inhaler

Möller¹,

Fritsche

Rivera

et al. 2011

Arzneimittelforschung

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“…Several studies have reported therapeutic equivalence and successful switches between the inhalers (e.g. from Turbuhaler to Aerolizer, Spiromax, Easyhaler and Novolizer) [61–64]. An example of a large scale switch in real-life practice comes from Norway, where the health authority (Statens legemiddelverk) included the Bufomix Easyhaler and Duoresp Spiromax in its switch regimen of DPIs containing budesonide/formoterol in Norwegian pharmacies, starting on July 1, 2018 [65].…”

Section: Inhalers Are For Patientsmentioning

confidence: 99%

Understanding Dry Powder Inhalers: Key Technical and Patient Preference Attributes

Levy¹,

Carroll

Alonso

et al. 2019

Adv Ther

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Inhalable medications for patients with asthma and chronic obstructive pulmonary disease (COPD) can be confusing even for health care professionals because of the multitude of available devices each with different operating principles. Dry powder inhalers (DPI) are a valuable option for almost all of the patients with asthma or COPD. Based on recorded patient inspiratory profiles, the peak inspiratory flow requirement of 30 L min−1 of high-resistance devices does not usually pose any practical limitations for the patients. Suboptimal adherence and errors in device handling are common and require continuous checking and patient education in order to avoid these pitfalls of all inhalation therapy. The aim of this opinion paper is to describe the working principles of DPIs and to summarise their key properties in order to help prescribing the correct inhaler for each patient.Funding: Orion Pharma.

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“…The device is activated and releases a sufficient amount of the drug with a minimum inspiratory flow rate of 35-50 l/min, making it suitable even for patients with low inspiratory flow rates such as children, elderly patients, or patients with severe airway obstruction [4,5]. In controlled clinical trials the FN achieved a high lung deposition [6], was efficient and well-tolerated in patients with bronchial asthma, and had a high patient acceptance [7,8,9].…”

Section: Introductionmentioning

confidence: 99%

Improvement of Asthma Therapy by a Novel Formoterol Multidose Dry Powder Inhaler

Moeller

Grimmbacher²,

Munzel³

2011

Arzneimittelforschung

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The objective of this post-marketing surveillance (PMS) was the evaluation of efficacy, tolerability, and acceptance of the advanced formoterol (CAS 73573-87-2) multidose dry powder inhaler (MDPI) Formatris 6 microg/12 microg Novolizer (FN) in asthmatic patients (n = 5219) in a real-life setting. A total of 2727 patients (52%) received concomitant anti-inflammatory treatment exclusively via a budesonide Novolizer (BN). Efficacy of the FN was assessed by measurement of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) before and after 4 weeks of therapy. The severity of cough, wheezing, diurnal dyspnea, nocturnal dyspnea and dyspnea on physical effort were assessed on a four-point scale, and a severity sum score was calculated. The patients' satisfaction with the multiple feedback mechanisms, handling and safety of the FN was also assessed. The physicians judged the patient compliance and any improved inhalation reassurance due to FN control mechanisms in comparison with other inhalation systems. FN use (n = 2727) was associated with improved lung function. After 4 weeks, PEF increased by 26% (from 270 L/min to 340 L/min) and the median FEV1 increased by 24% (from 2.1 L to 2.6 L). The median severity sum score decreased from 8.0 before therapy to 3.0 after therapy. Most patients assessed the control mechanisms and safety functions of the FN as 'very good' or 'good'. 96% of patients were satisfied with the optical control mechanism, 92% with the acoustic mechanism, 70% with the taste feedback, 89% with the dose counter and 76% with the overdose prevention. The majority of patients (95%) confirmed that the multiple feedback mechanisms reassured correct drug intake, with 83% rating the FN as 'much better' or 'better' than previously used inhalers. The physicians confirmed that in contrast to previously used inhalers the FN ensured correct inhalation in 87% of all patients. The physicians were satisfied with the patients' compliance in 95% of cases. Finally, the majority of patients (98%) were highly satisfied with the correct inhalation feedback mechanism. 94% of patients intended to continue FN therapy beyond the study. Overall, FN reduced the patients' asthma symptoms and improved lung function, possibly due to improved compliance with therapy. The correct inhalation feedback mechanisms and safety functions of the device were assessed very positively by patients and were considered by the physicians to be important in improving inhalation reassurance and patient compliance.

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Clinical Equivalence Trial on Budesonide Delivered either by the Novolizer<sup>®</sup> Multidose Dry Powder Inhaler or the Turbuhaler<sup>®</sup> in Asthmatic Patients

Cited by 20 publications

References 14 publications

Improvement of Asthma Therapy by a Novel Budesonide Multidose Dry Powder Inhaler

Improvement of Asthma Therapy by a Novel Budesonide Multidose Dry Powder Inhaler

Understanding Dry Powder Inhalers: Key Technical and Patient Preference Attributes

Improvement of Asthma Therapy by a Novel Formoterol Multidose Dry Powder Inhaler

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