Abstract:
OBJECTIVES:This randomized, double-blind, placebo-controlled, cross-over, Phase II dose-ranging study investigated the efficacy and safety of GP MDI (glycopyrronium administered by metered dose inhaler formulated using co-suspension delivery technology) compared with an open-label active comparator, salmeterol dry powder inhaler (SAL DPI), in subjects with intermittent or mild-to-moderate persistent asthma. METHODS:Subjects were randomized to receive five of seven treatments (GP MDI 28.8, 14.4, 7.2, 3.6, and 1.9 μg, placebo MDI, and SAL DPI 50 μg), each for a 14-day period. The primary endpoint was peak change from baseline in forced expiratory volume in 1 s (FEV1) on Day 15. Secondary endpoints included additional lung function parameters and symptoms (Asthma Control Questionnaire-5). Safety was monitored throughout. RESULTS:Of 248 subjects randomized, 211 completed the study. All doses of GP MDI resulted in significant improvements in the primary endpoint compared with placebo MDI in a dose-ordered fashion (range 85-155 mL, p < .0001), without appreciable differences between the two highest doses of GP MDI (28.8 and 14.4 μg) and SAL DPI 50 μg. Improvements in secondary lung function endpoints and symptoms were generally dose-ordered, with GP MDI 28.8 μg showing the greatest improvements. Similar results were observed when endpoints were analyzed based on subjects' background use of inhaled corticosteroids (yes/no). All GP MDI doses were well tolerated with no evidence of a dose-related effect on adverse events. CONCLUSIONS:The results of this study suggest that GP MDI could offer an important treatment option for maintenance therapy of asthma, and warrants further investigation in Phase III clinical trials.
journal_name
Respir Medjournal_title
Respiratory medicineauthors
Kerwin E,Wachtel A,Sher L,Nyberg J,Darken P,Siddiqui S,Duncan EA,Reisner C,Dorinsky Pdoi
10.1016/j.rmed.2018.04.013subject
Has Abstractpub_date
2018-06-01 00:00:00pages
39-47eissn
0954-6111issn
1532-3064pii
S0954-6111(18)30121-5journal_volume
139pub_type
杂志文章,随机对照试验abstract:BACKGROUND:Current evidence suggests that blood eosinophil levels (Eos) are associated with chronic obstructive pulmonary disease (COPD) treatment response and natural history. This analysis investigated the relationship between Eos levels and clinical characteristics in a representative cohort of US subjects with spir...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2016.01.013
更新日期:2016-03-01 00:00:00
abstract:BACKGROUND:Impaired cardiac function and sleep-disordered breathing (SDB) are associated with progression of chronic kidney disease (CKD) in heart failure (HF) patients. Adaptive servo-ventilation (ASV) therapy improves cardiac function in HF patients regardless of the SDB severity through hemodynamic support and preve...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2011.09.001
更新日期:2011-12-01 00:00:00
abstract::This study aims to investigate the possibility of additional value of leukotriene receptor antagonist (LTA) on dyspnea score, arterial blood gases (ABG), pulmonary function tests (PFTs), and quality of life (St. George QoL) in chronic obstructive pulmonary disease (COPD) patients. In this randomized, prospective, sing...
journal_title:Respiratory medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/j.rmed.2004.09.008
更新日期:2005-04-01 00:00:00
abstract::It has been hypothesized that hepatocyte growth factor (HGF) may play an important role in regulating the growth of lung epithelium and in the regeneration of the lung as a paracrine or endocrine factor in idiopathic pulmonary fibrosis (IPF). Based on this background, serum HGF was measured in 31 IPF patients (21 male...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/s0954-6111(97)90083-4
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abstract:BACKGROUND:Supplemental oxygen is a recommended therapy option in stable hypoxemic COPD patients. Often, supplemental oxygen is provided by continuous flow (CF). However, demand oxygen delivery systems (DODS) that provide an oxygen bolus only during inspiration have gained increasing use as they prolong oxygen cylinder...
journal_title:Respiratory medicine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.rmed.2019.08.001
更新日期:2019-09-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2020.106062
更新日期:2020-01-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2005.05.011
更新日期:2006-02-01 00:00:00
abstract::This double-blind, placebo-controlled, crossover study was performed to evaluate the effect of terbutaline administered by a turbuhaler on spirometry, walking distance and dyspnoea during exercise in patients with chronic obstructive lung disease (COLD) and to evaluate relationships between changes in spirometry and w...
journal_title:Respiratory medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0954-6111(06)80221-0
更新日期:1992-03-01 00:00:00
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更新日期:2012-11-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章,多中心研究
doi:10.1016/j.rmed.2009.05.021
更新日期:2009-12-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2007.07.024
更新日期:2008-01-01 00:00:00
abstract::The principals of rehabilitation medicine are to prevent muscle atrophy and improve mobility. Exacerbations of chronic obstructive pulmonary disease (COPD) are associated with muscle atrophy and yet many patients do not undergo pulmonary rehabilitation until they have been in stable health for some time. We investigat...
journal_title:Respiratory medicine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.rmed.2005.02.033
更新日期:2005-10-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2011.01.004
更新日期:2011-06-01 00:00:00
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journal_title:Respiratory medicine
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doi:10.1016/j.rmed.2011.08.018
更新日期:2011-12-01 00:00:00
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pub_type: 临床试验,杂志文章
doi:10.1053/rmed.2001.1286
更新日期:2002-05-01 00:00:00
abstract::Pneumocystis carinii colonization was studied in 90 men using the polymerase chain reaction. These comprised ten heterosexual controls; ten HIV-seronegative homosexual controls; 20 HIV-seropositive homosexuals with blood CD4 count > 400 x 10(6) l-1; 20 HIV-seropositive homosexuals with CD4 < 400 x 10(6) l-1; ten HIV-s...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/0954-6111(93)90008-n
更新日期:1993-10-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1053/rmed.2000.0797
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journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2016.02.004
更新日期:2016-04-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.rmed.2007.05.005
更新日期:2007-09-01 00:00:00
abstract::Asthma is a very common respiratory disease which is characterized by the presence of cytokine-mediated airway inflammation leading to smooth muscle contraction, oedema and progressive airway damage in some cases. In light of our recent finding of an increased sero-prevalence of Helicobacter pylori in bronchiectasis, ...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1053/rmed.2000.0817
更新日期:2000-08-01 00:00:00
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doi:10.1016/s0954-6111(97)90093-7
更新日期:1997-10-01 00:00:00
abstract::Invariant natural killer T (NKT) cells might contribute to the amplified and prolonged T-cell immune response that characterizes sarcoidosis. Therefore, we want to investigate the frequency and distribution of pulmonary invariant NKT cells in corticosteroid-naïve patients with sarcoidosis. We used multi-parameter flow...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2009.11.008
更新日期:2010-04-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2017.03.027
更新日期:2017-05-01 00:00:00
abstract::In response to the introduction of ethnic monitoring within the U.K. hospital inpatient data set, this study investigates the variations in secondary healthcare utilization by Black and minority ethnic communities whose cause of admission is related to asthma. The study examines all residents of the West Midlands: ove...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/s0954-6111(98)90511-x
更新日期:1998-04-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2020.105982
更新日期:2020-01-01 00:00:00
abstract::Several monoclonal antibodies (mAbs) (omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab) are currently approved for the treatment of severe asthma. They have complex pharmacokinetic profiles. These profiles are unique in that they are dependent on their structure as well as can be markedly influenced by...
journal_title:Respiratory medicine
pub_type: 杂志文章,评审
doi:10.1016/j.rmed.2019.05.005
更新日期:2019-07-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1053/rmed.2000.0776
更新日期:2000-06-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章,多中心研究
doi:10.1016/j.rmed.2015.06.002
更新日期:2015-08-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 杂志文章,多中心研究
doi:10.1016/j.rmed.2005.11.022
更新日期:2006-08-01 00:00:00
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journal_title:Respiratory medicine
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1998-02-01 00:00:00