International journal of chronic obstructive pulmonary disease
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Int J Chron Obstruct Pulmon Dis · Jan 2019
Randomized Controlled TrialAdherence to roflumilast under dose-escalation strategy in Korean patients with COPD.
Frequent development of adverse events and consequent low adherence are major barriers in the wide use of roflumilast. Asian patients may be more susceptible to adverse events due to low BMI. In this study, we aimed to determine if a dose-escalation strategy is useful to improve the drug adherence rate. ⋯ This study is registered at www.ClinicalTrials.gov with identifier number NCT02018432.
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Int J Chron Obstruct Pulmon Dis · Jan 2018
Randomized Controlled Trial Multicenter Study Comparative StudyThe impact of indacaterol/glycopyrronium fixed-dose combination versus tiotropium monotherapy on lung function and treatment preference: a randomized crossover study - the FAVOR study.
The objective of the FAVOR study was to evaluate the effect of indacaterol/glycopyrronium (IND/GLY) versus tiotropium on peak forced expiratory volume in 1 s (FEV1) and also to investigate patient satisfaction and treatment preference. ⋯ This study indicated that, beyond FEV1, important patient-reported outcomes improved with the open-label dual bronchodilator IND/GLY when compared with tiotropium. This study suggests that individual patients felt the lung function benefits with IND/GLY compared with tiotropium, which, in turn, may also have contributed to the preference for IND/GLY.
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Int J Chron Obstruct Pulmon Dis · Jan 2018
Randomized Controlled TrialA randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD.
Functional respiratory imaging (FRI) uses high-resolution computed tomography (HRCT) scans to assess changes in airway volume and resistance. ⋯ ClinicalTrials.gov: NCT02643082.
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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 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.