International journal of chronic obstructive pulmonary disease
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Int J Chron Obstruct Pulmon Dis · Jan 2018
Randomized Controlled Trial Multicenter Study Comparative StudyPharmacokinetics of glycopyrronium/formoterol fumarate dihydrate delivered via metered dose inhaler using co-suspension delivery technology in patients with moderate-to-very severe COPD.
The efficacy and tolerability of GFF MDI (Bevespi Aerosphere®), a fixed-dose combination of glycopyrronium (GP)/formoterol fumarate dihydrate (FF) 14.4/10 μg (equivalent to glycopyrrolate/formoterol fumarate 18/9.6 μg) delivered by metered dose inhaler (MDI) using innovative co-suspension delivery technology, has been investigated in a Phase III clinical trial program (NCT01854645, NCT01854658, NCT01970878) in patients with COPD. Here, we present findings from a pharmacokinetic (PK) sub-study of NCT01854645 (PINNACLE-1). ⋯ Overall, the results have characterized the accumulation of glycopyrronium and formoterol associated with GFF MDI, GP MDI, and FF MDI, and indicated that there were no meaningful PK interactions, whether drug-drug or due to formulation, between glycopyrronium and formoterol following treatment with GFF MDI formulated using co-suspension delivery technology.
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Int J Chron Obstruct Pulmon Dis · Jan 2018
Randomized Controlled TrialSatisfaction, preference and error occurrence of three dry powder inhalers as assessed by a cohort naïve to inhaler operation.
Inhaled medication is central to the treatment of COPD. Various types of inhaler devices, which directly deliver medication to the lung, have been developed. However, patients often exhibit incorrect techniques of inhaler usage. Effectiveness of therapy may be affected by the ease of device usage, size, convenience of use, durability, clarity of instructions and device preferences of patients. This study compares the satisfaction and preference, as well as error occurrence, with the use of Genuair®, Ellipta™ and Breezhaler™ by healthy subjects in Hong Kong. ⋯ Breezhaler seemed to be more comfortable and easy to carry, but users made less critical errors when using Ellipta after reading the instructions only. Genuair provided the clearest indication of correct dose preparation and inhalation.
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Int J Chron Obstruct Pulmon Dis · Jan 2018
Randomized Controlled TrialEfficacy and safety of four doses of glycopyrrolate/formoterol fumarate delivered via a metered dose inhaler compared with the monocomponents in patients with moderate-to-severe COPD.
To determine the efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI 36/9.6, 36/7.2, 18/9.6, 9/9.6 µg) using innovative co-suspension delivery technology, compared with glycopyrrolate (GP) MDI 36 µg and formoterol fumarate (FF) MDI 9.6 µg, in patients with moderate-to-severe COPD. ⋯ While all doses of GFF MDI were superior to GP MDI 36 µg for the primary end-point, in this study neither superiority of GFF MDI to FF MDI 9.6 µg nor a clear dose-response was observed. All treatments were well tolerated with no unexpected safety findings.
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Int J Chron Obstruct Pulmon Dis · Jan 2018
Randomized Controlled Trial Multicenter Study Comparative StudyUse of a 4-week up-titration regimen of roflumilast in patients with severe COPD.
The oral selective phosphodiesterase-4 inhibitor roflumilast (ROF) reduces exacerbations in patients with severe COPD. Adverse events (AEs) can cause early ROF discontinuation. Alternative dosing strategies may help patients continue their therapy. ⋯ A dose of ROF 250 µg OD for 4 weeks before escalation to the approved maintenance dose of 500 µg OD resulted in reduced treatment discontinuation and improved tolerability.
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Int J Chron Obstruct Pulmon Dis · Jan 2018
Randomized Controlled Trial Multicenter StudyDose-response of an extrafine dry powder inhaler formulation of glycopyrronium bromide: randomized, double-blind, placebo-controlled, dose-ranging study (GlycoNEXT).
An extrafine formulation of the long-acting muscarinic antagonist, glycopyrronium bromide (GB), has been developed for delivery via the NEXThaler dry powder inhaler (DPI). This study assessed the bronchodilator efficacy and safety of different doses of this formulation in patients with COPD to identify the optimal dose for further development. ⋯ This study supports the selection of GB 25 μg BID as the minimal effective dose for patients with COPD when delivered with this extrafine DPI formulation.