Abstract:
Purpose:Revefenacin, a long-acting muscarinic antagonist for nebulization, has been shown to improve lung function in patients with chronic obstructive pulmonary disease. Here we report pharmacokinetic (PK) and safety results from two multicenter, open-label, single-dose trials evaluating revefenacin in subjects with severe renal impairment (NCT02578082) and moderate hepatic impairment (NCT02581592). Subjects and methods:The renal impairment trial enrolled subjects with normal renal function and severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m2). The hepatic impairment trial enrolled subjects with normal hepatic function and moderate hepatic impairment (Child-Pugh class B). Subjects received a single 175-µg dose of revefenacin through nebulization. PK plasma samples and urine collections were obtained at multiple time points for 5 days following treatment; all subjects were monitored for adverse events. Results:In the renal impairment study, the maximum observed plasma revefenacin concentration (Cmax) was up to 2.3-fold higher and area under the concentration-time curve from time 0 to infinity (AUCinf) was up to 2.4-fold higher in subjects with severe renal impairment compared with those with normal renal function. For THRX-195518, the major metabolite of revefenacin, the corresponding changes in Cmax and AUCinf were 1.8- and 2.7-fold higher, respectively. In the hepatic impairment study, revefenacin Cmax and AUCinf were 1.03- and 1.18-fold higher, respectively, in subjects with moderate hepatic impairment compared with those with normal hepatic function. The corresponding changes in THRX-195518 Cmax and AUCinf were 1.5- and 2.8-fold higher, respectively. Conclusion:Systemic exposure to revefenacin increased modestly in subjects with severe renal impairment but was similar between subjects with moderate hepatic impairment and normal hepatic function. The increase in plasma exposure to THRX-195518 in subjects with severe renal or moderate hepatic impairment is unlikely to be of clinical consequence given its low antimuscarinic potency, low systemic levels after inhaled revefenacin administration, and favorable safety profile.
journal_name
Int J Chron Obstruct Pulmon Disauthors
Borin MT,Lo A,Barnes CN,Pendyala S,Bourdet DLdoi
10.2147/COPD.S203709subject
Has Abstractpub_date
2019-10-08 00:00:00pages
2305-2318eissn
1176-9106issn
1178-2005pii
203709journal_volume
14pub_type
杂志文章abstract::Currently, there is no cure for chronic obstructive pulmonary disease (COPD). The limited efficacy of current therapies for COPD indicates a pressing need to develop new treatments to prevent the progression of the disease, which consumes a significant amount of health care resources and is an important cause of morta...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章,评审
doi:10.2147/COPD.S32604
更新日期:2014-02-24 00:00:00
abstract:Purpose:To evaluate clinical periodontal status and microbiologic pathogens in patients with chronic obstructive pulmonary disease (COPD) and periodontitis. Patients and Methods:We conducted a case-control study of 60 periodontitis patients with COPD (case group) and 60 periodontitis patients with normal pulmonary fun...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S266612
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abstract:Purpose:Previous studies have described the incidence, risk factors, and outcomes for patients with acute exacerbations of COPD (AECOPD) developing acute kidney injury (AKI). However, little is known about the differences between community-acquired AKI (CA-AKI) and hospital-acquired AKI (HA-AKI) in patients with AECOPD...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S164648
更新日期:2018-07-17 00:00:00
abstract:BACKGROUND:In patients with acute hypercapnic respiratory failure (AHRF) during exacerbations of COPD, mortality can be high despite noninvasive ventilation (NIV). For some, AHRF is terminal and NIV is inappropriate. However there is no definitive method of identifying patients who are unlikely to survive. The aim of t...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S39403
更新日期:2013-01-01 00:00:00
abstract:BACKGROUND:It was reported that autonomic nervous system function is altered in subjects with chronic obstructive pulmonary disease (COPD). We evaluated short- and long-term fractal exponents of heart rate variability (HRV) in COPD subjects. PATIENTS AND METHODS:We analyzed data from 30 volunteers, who were divided in...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S15099
更新日期:2011-01-06 00:00:00
abstract:Introduction and aim:Abnormal brain structure and function in COPD has been reported on MRI. However, the deficit in local synchronization of spontaneous activity in patients with stable COPD remains unknown. The main aim of the present study was to explore spontaneous brain activity in patients with COPD compared with...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S190671
更新日期:2019-02-27 00:00:00
abstract:Purpose:To date, no consensus exists on the effects of systemic steroid use on pneumonic chronic obstructive pulmonary disease (COPD) exacerbation owing to trial design issues in previous trials involving these conditions. This multicenter study aimed to evaluate more precisely the effectiveness of the use of systemic ...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S271844
更新日期:2020-10-19 00:00:00
abstract::Chronic obstructive pulmonary disease (COPD) is the most common chronic lung disease in the world, and its associated health burdens and costs are mounting. Until recently, it was generally accepted that targeting the diagnosis of COPD early in its course was a relatively fruitless effort, since treatments other than ...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章,评审
doi:10.2147/COPD.S46198
更新日期:2014-02-27 00:00:00
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journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S182802
更新日期:2018-12-18 00:00:00
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journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S126192
更新日期:2017-02-24 00:00:00
abstract:Rationale:Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are caused by a variety of different etiologic agents. Our aim was to phenotype COPD exacerbations using imaging (chest X-ray [CXR] and computed tomography [CT]) and to determine the possible role of the blood tests (C-reactive protein [CRP...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S152484
更新日期:2018-01-08 00:00:00
abstract:BACKGROUND:COPD patients are often prescribed multiple medications for their respiratory disease and comorbidities. This can lead to complex medication regimens resulting in poor adherence, medication errors, and drug-drug interactions. The relationship between clinical outcomes and medication burden beyond medication ...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S136256
更新日期:2017-10-06 00:00:00
abstract:Background:The DYNAGITO study was a Phase IIIb, randomized, double-blind, multicenter, active-controlled, parallel-group, 52-week study designed to determine the efficacy and safety of tiotropium and olodaterol combination therapy (TIO+OLO 5/5 μg) versus tiotropium monotherapy (TIO 5 μg) for reducing moderate-to-severe...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2018-07-13 00:00:00
abstract:BACKGROUND:Noncommunicable diseases have become a public heath problem in India concomitant with economic development, leading to increases in tobacco consumption, obesity, and changes in diet and lifestyle. Although observation suggests that tobacco consumption is a major risk factor for deaths due to circulatory, pul...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:
更新日期:2007-01-01 00:00:00
abstract:Introduction:With increasing availability of different treatments for chronic obstructive pulmonary disease (COPD), we sought to understand patient preferences for COPD treatment in the UK, USA, and Germany using a discrete choice experiment (DCE). Methods:Qualitative research identified six attributes associated with...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S221980
更新日期:2020-03-18 00:00:00
abstract:Purpose:Waterpipe (WP) use has become a global trend in young populations. However, there are few well-controlled studies focusing specifically on the chronic effects of exclusive WP use on young adults' respiratory health. We sought to compare in young adults the burden of respiratory symptoms in regular WP smokers (W...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章,多中心研究
doi:10.2147/COPD.S205050
更新日期:2019-08-13 00:00:00
abstract::COPD is a major cause of chronic morbidity and mortality throughout the world. Although tumor necrosis factor-α (TNF-α) has a critical role in the development of COPD, the role of different TNF receptors (TNFRs) in pulmonary emphysema has not been resolved. We aimed to clarify the role of TNFRs in the development of p...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S108919
更新日期:2016-07-28 00:00:00
abstract::Noninvasive ventilation (NIV) has been one of the major advances in respiratory medicine in the last decade. NIV improves quality of life, prolongs survival, and improves gas exchange and sleep quality in restrictive patients, but evidence available now does not allow us to establish clear criteria for prescribing NIV...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章,评审
doi:10.2147/copd.2006.1.2.129
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:Forced expiratory volume in 1 second (FEV1)/forced expiratory volume in 6 seconds (FEV6) has been proposed as an alternative to FEV1/forced vital capacity (FVC) for detecting airway obstruction. A fixed cut-off value for FEV1/FEV6 in a Korean population is lacking. We investigated a fixed cut-off for FEV1/FE...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S113568
更新日期:2016-08-19 00:00:00
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journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S268421
更新日期:2020-10-23 00:00:00
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journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S141694
更新日期:2017-08-26 00:00:00
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journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章,评审
doi:10.2147/COPD.S78875
更新日期:2015-10-22 00:00:00
abstract::COPD is a common complex disease characterized by progressive airflow limitation. Several genome-wide association studies (GWASs) have discovered genes that are associated with COPD. Recently, candidate genes for COPD identified by GWASs include CHRNA3/5 (cholinergic nicotine receptor alpha 3/5), IREB2 (iron regulator...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章,评审
doi:10.2147/COPD.S80227
更新日期:2015-10-19 00:00:00
abstract::Background: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) released an updated document in 2017 that excluded the spirometric parameter in the classification of patients. The validity of this new classification system in predicting mortality and respiratory hospitalization is still uncertain. Method...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S191362
更新日期:2019-04-29 00:00:00
abstract::TRPM8 plays a key role in COPD. The development of pulmonary hypertension (PH) in COPD adversely affects survival and exercise capacity. Thus, the aim of this study was to evaluate the possible association between single nucleotide polymorphisms (SNPs) in TRPM8 and COPD or PH in COPD among the Chinese Han population. ...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S109026
更新日期:2016-10-14 00:00:00
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journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章,多中心研究
doi:10.2147/COPD.S145599
更新日期:2017-10-26 00:00:00
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journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S223592
更新日期:2020-01-13 00:00:00
abstract::Bronchoconstriction has been reported in asthma and chronic obstructive pulmonary disease (COPD) patients after administration of some aqueous inhalation solutions. We investigated the incidence of this event during long-term clinical trials of tiotropium delivered via Respimat(®) Soft Mist™ Inhaler (SMI). We retrospe...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S16094
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND:Krasnoyarsk region is a territory with the widespread risk factors for chronic obstructive pulmonary disease (COPD) such as tobacco smoke, air pollution, and occupational exposure. An assessment of COPD prevalence based on medical diagnosis statistics underestimates the true COPD prevalence. This study aims ...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S79601
更新日期:2015-09-02 00:00:00
abstract:BACKGROUND:In addition to smoking, acute exacerbations are considered to be a contributing factor to progression of chronic obstructive pulmonary disease (COPD). However, these findings come from studies including active smokers, while results in ex-smokers are scarce and contradictory. The purpose of this study was to...
journal_title:International journal of chronic obstructive pulmonary disease
pub_type: 杂志文章
doi:10.2147/COPD.S76475
更新日期:2015-03-10 00:00:00