Abstract:
:Viozan (sibenadet HCl, AR-C68397AA) is a novel dual D2 dopamine receptor, beta2-adrenoceptor agonist that has been investigated for efficacy in alleviating the symptoms of chronic obstructive pulmonary disease (COPD). The slowly progressive nature of this disease means that patients will require ongoing therapeutic management for many years, or even decades. With such long-term treatment, the safety profile of new agents will be of paramount importance. As part of the large-scale assessment of sibenadet, a 12-month safety study has been conducted. Following completion of a 2-week baseline period, 435 adults with stable, symptomatic, smoking-related COPD were randomized to receive either 500 microg sibenadet or placebo delivered via pressurized metered dose inhaler (pMDI), three times daily for 52 weeks. Sibenadet therapy was generally well tolerated, with the only notable differences seen in the incidence of tremor and taste of treatment (16.9% vs. 4.1% and 14.5% vs. 4.1% in the sibenadet and placebo groups respectively). There were a total of 79 patients with serious adverse events (SAEs), 43 (14.8%) in the sibenadet pMDI group and 36 (24.8%) in the placebo group. No clinically significant abnormal laboratory values or overall differences between treatment groups were noted. Similarly, there were no clinically significant differences between the two treatment groups for cardiac variables, or in vital signs. The secondary variables showed no notable differences with respect to lung function, exacerbations or health-related quality of life. Due to the effective beta2-agonist properties, patients in the sibenadet group did, however, report reduced rescue medication usage at all timepoints. While the results of this study show that, overall, sibenadet therapy was well tolerated, the lack of sustained benefit reported in large-scale clinical efficacy studies means that sibenadet development will not be continued.
journal_name
Respir Medjournal_title
Respiratory medicineauthors
Hiller FC,Alderfer V,Goldman Msubject
Has Abstractpub_date
2003-01-01 00:00:00pages
S45-52eissn
0954-6111issn
1532-3064pii
S0954-6111(03)90060-6journal_volume
97 Suppl Apub_type
临床试验,杂志文章,多中心研究,随机对照试验abstract:RATIONALE:The development of chronic obstructive pulmonary disease (COPD) in smokers and their susceptibility to infections is not fully understood. Recent evidences suggest that Clara cells play a part in host defense, immunomodulatory response and airways remodelling through the production of specific factors such as...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2007.05.023
更新日期:2007-10-01 00:00:00
abstract::A multiplex polymerase chain reaction (PCR) was developed for the simultaneous detection of Chlamydia pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila. Oligonucleotide primers for the amplification of the DNA of these three organisms were optimized for use in combination in the same reaction. PCR products ...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2003.11.012
更新日期:2004-06-01 00:00:00
abstract:BACKGROUND:Asthma in the elderly as well as asthma of adult-onset has been associated with increased morbidity, but little is known specifically about the effects of age on clinical and inflammatory outcomes in severe refractory asthma. The aims of the study were to examine the effects of age [<65 versus ≥65 years] and...
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pub_type: 杂志文章
doi:10.1016/j.rmed.2016.07.005
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND:Many patients with DMD undergo tracheostomy. Tracheostomy is associated with certain complications, however its effect on prognosis is not known. METHODS:The relationship between type of mechanical ventilation and survival at 12 years was evaluated in a prospective cohort of patients with Duchenne muscular ...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2016.04.009
更新日期:2016-06-01 00:00:00
abstract:INTRODUCTION:The release of tumor necrosis factor (TNF-alpha) is increased in sarcoidosis patients. TNF-alpha exerts its effect by binding to specific cell surface receptors. There are only fragmentary data concerning the expression of tumor necrosis factor receptors (TNFRs) on bronchoalveolar lavage fluid (BALF) and p...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2006.06.004
更新日期:2007-03-01 00:00:00
abstract:BACKGROUND:Trends in prevalence of asthma and allergic diseases are still controversial, and rarely studied among adolescents at midpoint of puberty. METHODS:In 2000, a questionnaire was mailed to adolescents (n = 18,158) attending 9th grade at school and living in Västra Götaland County, Sweden. Eight years later, th...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2014.02.011
更新日期:2014-05-01 00:00:00
abstract::The pathophysiology of corticosteroid-induced osteoporosis is complex, but centres around a primary inhibition of osteoblastic activity compounded by the effects of secondary hyperparathyroidism. The preservation of the microanatomy of bone in the early stages of the disease, coupled with strategies to prevent the eme...
journal_title:Respiratory medicine
pub_type: 杂志文章,评审
doi:10.1016/s0954-6111(05)80252-5
更新日期:1993-02-01 00:00:00
abstract::To document the rate and cost of antibiotic prescribing for patients diagnosed only with influenza during US ambulatory care visits. Federal survey data for 1997-2001 were used to estimate outpatient trends for all patients and healthy people age 5-49 years. Cost estimates were based on Medicare payments and Red Book ...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2004.03.021
更新日期:2004-11-01 00:00:00
abstract:BACKGROUND:Discrepancies have been observed between clinical, physiological, and inflammatory asthma control criteria, mostly in asthmatic subjects using regular inhaled corticosteroids (ICS) treatment. This study compared the prevalence of discrepancies between these 3 control parameters in mild asthmatic subjects not...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2012.12.015
更新日期:2013-04-01 00:00:00
abstract::Lactose is widely used as a carrier of drugs in inhalation devices for asthmatic patients, but some clinicans have suspected that it may cause bronchoconstriction. Only a few studies have been done to examine this and the results are not uniform. This study was conducted to determine the effects of inhalation grade la...
journal_title:Respiratory medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1053/rmed.2001.1150
更新日期:2001-11-01 00:00:00
abstract:BACKGROUND:Chronic obstructive pulmonary disease (COPD) is an inflammatory condition characterized by oxidative stress and the formation of volatile organic compounds (VOCs) secreted via the lungs. We recently developed a methodological approach able to identify profiles of VOCs in breath unique for patient groups. Her...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2009.10.018
更新日期:2010-04-01 00:00:00
abstract:BACKGROUND:Nitrite in exhaled breath condensate (EBC) has been shown to be elevated in cystic fibrosis (CF), while exhaled nitric oxide (FENO) is paradoxically low. This has been argued to reflect increased metabolism of NO while its diffusion is obstructed by mucus. However, we wanted to study the possible influence o...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2008.09.009
更新日期:2009-02-01 00:00:00
abstract:BACKGOUND AND OBJECTIVES:The disadvantages of custom-made mandibular advancement devices (MAD) for obstructive sleep apnoea (OSA) therapy are the cost and delay required to manufacture the device. This study aimed to evaluate the efficacy of a titrable, thermoplastic MAD compared to a custom-made MAD for OSA therapy. ...
journal_title:Respiratory medicine
pub_type: 临床试验,杂志文章
doi:10.1016/j.rmed.2017.08.004
更新日期:2017-10-01 00:00:00
abstract::Nasal mucociliary system is the first line of defense of the upper airways and may be affected acutely by exposure to particulate matter (PM) from biomass burning. Several epidemiologic studies have demonstrated a consistent association between levels of air pollution from biomass burning with increases in hospitaliza...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2011.08.003
更新日期:2011-11-01 00:00:00
abstract::Systemic inflammation may be present in patients with chronic obstructive pulmonary disease (COPD). Exercise is known to elicit an inflammatory response. We hypothesized that the systemic inflammatory response to exercise might be exaggerated in COPD patients compared to healthy subjects. Sixteen COPD patients and 11 ...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2005.03.028
更新日期:2005-12-01 00:00:00
abstract:OBJECTIVE:To determine the characteristics of persons with cognitive impairment being able to self-manage in chronic obstructive pulmonary disease (COPD). METHODS:In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance this systematic review examined all studies in E...
journal_title:Respiratory medicine
pub_type: 杂志文章,评审
doi:10.1016/j.rmed.2017.06.006
更新日期:2017-08-01 00:00:00
abstract:BACKGROUND:Familial dysautonomia (Riley-Day syndrome, hereditary sensory autonomic neuropathy type-III) is a rare genetic disease caused by impaired development of sensory and afferent autonomic nerves. As a consequence, patients develop neurogenic dysphagia with frequent aspiration, chronic lung disease, and chemorefl...
journal_title:Respiratory medicine
pub_type: 杂志文章,评审
doi:10.1016/j.rmed.2018.06.017
更新日期:2018-08-01 00:00:00
abstract:BACKGROUND:Lung fibrosis is attributed to derangements in extracellular matrix remodeling, a process driven by collagen turnover. We examined the association of two collagen biomarkers, carboxy-terminal telopeptide of collagen type I (ICTP) and amino-terminal propeptide of type III procollagen (PIIINP), with subclinica...
journal_title:Respiratory medicine
pub_type: 杂志文章,多中心研究
doi:10.1016/j.rmed.2018.06.001
更新日期:2018-07-01 00:00:00
abstract:BACKGROUND:Bronchiectasis is a common disabling but rarely fatal disease. However the long-term prognosis and risk factors for mortality are not well known. OBJECTIVE:The aim of this study was to determine prospectively the survival and predictive factors of mortality in patients with bronchiectasis, during 4-year fol...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2007.02.002
更新日期:2007-07-01 00:00:00
abstract:BACKGROUND:Omalizumab is a recombinant humanized monoclonal anti-IgE antibody approved in adults and adolescents with moderate-to-severe persistent allergic asthma inadequately controlled with inhaled corticosteroids (ICS). EXCELS is an ongoing prospective observational cohort study of approximately 5000 omalizumab-tre...
journal_title:Respiratory medicine
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/j.rmed.2012.09.008
更新日期:2013-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Mycobacterium tuberculosis has been proposed as a candidate agent for the cause of sarcoidosis. The QuantiFERON-TB Gold test has a higher specificity for detecting M. tuberculosis infection than the conventional tuberculin skin test. This study aimed to investigate the rate of positive QuantiFE...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2007.09.013
更新日期:2008-02-01 00:00:00
abstract::Continuous positive airway pressure (CPAP) is the treatment of choice for obstructive sleep apnoea syndrome (OSAS), but many patients find this treatment intolerable. The aim of this study was to characterize patients who were unable to tolerate CPAP treatment (non-complaint) as opposed to those who continued using CP...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1053/rmed.1999.0703
更新日期:2000-02-01 00:00:00
abstract::Ulcerative colitis is one of the few diseases in which smoking appears to confer some benefit (1). We report a patient whose ulcerative colitis deteriorated on several occasions on stopping cigarettes, and improved on restarting smoking. As a result, she continued smoking despite developing airflow limitation and seve...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/0954-6111(95)90235-x
更新日期:1995-10-01 00:00:00
abstract:BACKGROUND:The aim of the study was to investigate the efficacy and safety of ciclesonide compared with budesonide in adolescents with severe asthma. METHODS:In this randomized, double-blind, double-dummy, parallel-group study, patients aged 12-17 years with severe asthma were treated with budesonide 400 microg once d...
journal_title:Respiratory medicine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.rmed.2007.05.006
更新日期:2007-10-01 00:00:00
abstract:OBJECTIVE:To examine medication adherence and persistence among COPD patients during their last year of life. DATA SOURCE:National VA databases were used to identify patients who had COPD and died between 1999 and 2003. STUDY DESIGN:We examined use of inhaled corticosteroids (ICS), long acting beta(2) agonists (LABA)...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2008.11.004
更新日期:2009-04-01 00:00:00
abstract:BACKGROUND:An increasing number of studies confirm that pathogenesis and prevalence of bronchial asthma are age and sex dependent. Detailed physiological mechanisms of the changing sex ratios with age are not fully known, however, the gender (socio-cultural) factors are also imperative. Although multiple factors defini...
journal_title:Respiratory medicine
pub_type: 杂志文章,评审
doi:10.1016/j.rmed.2009.01.006
更新日期:2009-05-01 00:00:00
abstract:BACKGROUND:Idiopathic pleuroparenchymal fibroelastosis (IPPFE) is a rare idiopathic interstitial pneumonia characterized by an upper lobe-dominant interstitial increase in predominantly elastic fibers. The accumulation of cases has resulted in a refinement of the disease concept, but there are no blood biomarkers to ai...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2020.106077
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:Pulmonary rehabilitation is very effective in improving exercise capacity, dyspnea and quality of life in the small group of patients with moderate to severe COPD. Given that little is known about exercise training in the large group of patients with mild to moderate COPD, we assessed the effectiveness of an...
journal_title:Respiratory medicine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.rmed.2020.105943
更新日期:2020-01-01 00:00:00
abstract:BACKGROUND:Smoking and obesity might alter the risk of sarcoidosis. However, the data remained inconclusive. METHODS:A cohort of Olmsted County, Minnesota residents diagnosed with sarcoidosis between January 1, 1976 and December 31, 2013 was identified based on individual medical record review. For each sarcoidosis su...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2016.10.003
更新日期:2016-11-01 00:00:00
abstract:OBJECTIVES:To compare the prognostic value of FENO with bronchoprovocation testing when the clinical course within the first year after assessment was taken into account; to compare the prognostic values with respect to eosinophilic versus non-eosinophilic inflammatory pattern. METHODS:Cross-sectional diagnostic study...
journal_title:Respiratory medicine
pub_type: 杂志文章
doi:10.1016/j.rmed.2013.11.008
更新日期:2014-01-01 00:00:00