Abstract
Objectives:The long-acting muscarinic antagonist (LAMA) glycopyrronium (NVA237) has recently been approved as a once-daily treatment for COPD. The objectives of this study were to determine the dose delivery characteristics of glycopyrronium and compare them with those of the LAMA tiotropium, both delivered by their respective capsule-based dry-powder inhalers (DPIs).Research design and methods:Seven inhalation profiles derived from patients with moderate and severe COPD were reproduced to determine the aerodynamic particle size distribution of glycopyrronium delivered by the Breezhaler device, a low-resistance DPI. Theoretical respiratory tract deposition was estimated using a semi-empirical model for healthy lungs. These results were compared with those of tiotropium delivered by the high-resistance HandiHaler device obtained in a previous study using the same set of inhalation profiles. Study limitations are that fine particle fraction (FPF) and particle size are generated by the inhalers are not a direct measure of lung deposition, and the bronchodilator effect of inhaled drugs does not depend solely upon the percentage of the total dose that reaches the lung.Results:The mean FPF (≤4.7 µm) was 42.6% of the nominal dose (which refers to the content of the capsule) for glycopyrronium and 9.8% for tiotropium while the mass median aerodynamic diameter (MMAD) was 2.8 µm and 3.9 µm for glycopyrronium and tiotropium, respectively. The mean estimated intrathoracic drug deposition as a percentage of the mean dose delivered to the Next Generation Impactor was 39% for glycopyrronium and 22% for tiotropium.Conclusions:The glycopyrronium capsule-based DPI delivered a higher FPF and greater and more consistent intrathoracic deposition irrespective of age and disease severity compared to the tiotropium capsule-based DPI, suggesting that it may be suitable for use by patients with a wide range of COPD severities.
Highlights
Chronic obstructive pulmonary disease (COPD), a preventable lung disease characterized by progressive airflow limitation, is a leading cause of mortality and morbidity world-wide[1]
No auth isplaConclusions: Un d The glycopyrronium capsule-based dry-powder inhalers (DPIs) delivered a higher fine particle fraction (FPF) and greater and more consistent intrathoracic deposition irrespective of age and disease severity compared to the tiotropium capsulebased DPI, suggesting that it may be suitable for use by patients with a wide range of COPD severities
Seven breathing patterns derived from patients with moderate and severe COPD were reproduced to determine the dose delivery characteristics of glycopyrronium and tiotropium (Table 1 and Figure 2)
Summary
Chronic obstructive pulmonary disease (COPD), a preventable lung disease characterized by progressive airflow limitation, is a leading cause of mortality and morbidity world-wide[1]. Glycopyrronium delivered by a dry-powder inhaler in COPD Colthorpe et al 11 dry-powder inhalers (DPIs) are the main two types of inhaler currently available[3]. The Respimat* inhaler, is a third type of device, which uses the mechanical energy of a spring to atomize the drug solution by forcing it through an extremely fine nozzle system, generating a slow-moving fine mist[5]. The device requires the patient to coordinate inhalation with actuation. DPIs, in which the patient’s inspiratory flow provides the force to generate the drug aerosol, have become increasingly popular in COPD as the lack of the need to co-ordinate actuation and inhalation is important in minimizing patient handling errors and optimizing drug delivery[4]
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