Abstract:
OBJECTIVE:The efficacy and tolerability of a new combination inhaler containing both salmeterol 50mg and fluticasone 100mg in a single device was compared with the delivery of the two drugs via two separate inhalers in a multicentre, double-blind, double-dummy study. PATIENTS:244 symptomatic asthma patients (age range 12 to 78 years) were randomised to a 12-week treatment period with either salmeterol/fluticasone (50/100mg twice daily) via a single inhaler (combination) and placebo twice daily via another, or salmeterol 50mg twice daily via one inhaler and fluticasone 100mg twice daily via another (concurrent). RESULTS:Morning peak expiratory flow rate (PEFR), symptoms and tolerability were collected throughout the treatment period. Adjusted mean improvements in morning PEFR were 42 and 33 L/min for combination and concurrent therapies, respectively, over the 12-week treatment period. Adjusted mean improvements in forced expiratory volume in 1 second (FEV(1)) from baseline at week 12 were 0.20 and 0.17L for combination and concurrent therapies, respectively. 60% of patients receiving combination inhaler and 64% of those receiving concurrent therapy had a mean daytime symptom score of zero over the treatment period compared with 17 and 15%, respectively, at baseline. Both treatments were well tolerated. Geometric mean morning serum cortisol levels were similar and no differences in the frequency of abnormal results were noted between the two groups. CONCLUSION:This was the first study reporting the control of asthma by administration of salmeterol and fluticasone in combination via a single inhaler. The new combination inhaler was as effective and well tolerated as the two drugs administered individually and has potential advantages in terms of convenience.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Bateman ED,Britton M,Carrillo J,Almeida J,Wixon Cdoi
10.2165/00044011-199816030-00003subject
Has Abstractpub_date
1998-01-01 00:00:00pages
193-201issue
3eissn
1173-2563issn
1179-1918pii
160303journal_volume
16pub_type
杂志文章abstract:OBJECTIVE:This study aimed to investigate the relative bioavailability and bioequivalence of two omeprazole enteric-coated formulations following repeated doses (steady state) in healthy male and female adult volunteers. DESIGN AND STUDY PARTICIPANTS:The study formulation (Ompranyt® 20mg capsules, Bial-Industrial Farm...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200121030-00006
更新日期:2001-03-01 00:00:00
abstract::Psychotropic medications and alcohol are potential risk factors for falls in older adults. However, there has been no appraisal of the literature on whether these medications, both singly and in combination with alcohol, are associated with falls in community dwelling older adults (those aged 60 years and older living...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-018-0721-6
更新日期:2019-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Tendon rupture can result from fluoroquinolone exposure. The objective of this study was to quantify relative and absolute risk and determine how risk is affected by timing of exposure. METHODS:The UK Health Improvement Network primary care database was used to perform a nested case-control st...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0729-y
更新日期:2019-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Cerebral vasospasm is a common and serious complication of aneurysmal subarachnoid haemorrhage (SAH). Many studies have revealed a role of inflammation in the development of cerebral vasospasm. This study aimed to investigate whether topically administered dexamethasone could attenuate vasospas...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/00044011-200727120-00004
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Phenylephrine HCl 10 mg has been used as a nasal decongestant for over 50 years, yet only limited pharmacokinetic and metabolic data are available. The purpose of this study was to evaluate single-dose pharmacokinetics and safety of phenylephrine HCl 10, 20, and 30 mg and to assess cardiovascu...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-015-0311-9
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Matrix metalloproteinases (MMPs) are proteases with different biological and pathological activities, and many have been linked to several diseases. Targeting individual MMPs may offer a safer therapeutic potential for several diseases. We assessed the safety, tolerability, and pharmacokinetic...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00981-9
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The management of patients on vitamin K antagonist therapy who require an invasive procedure is problematic. A randomised, controlled, double-blind clinical trial was designed to compare the efficacy and safety of bemiparin, a low molecular weight heparin (LMWH), with unfractionated heparin (UF...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-013-0141-6
更新日期:2013-12-01 00:00:00
abstract::Oral teneligliptin [Teneglucon® (Argentina)], a dipeptidyl peptidase-4 inhibitor, is indicated for the treatment of adults with type 2 diabetes (T2DM). This article reviews the pharmacology, therapeutic efficacy and tolerability of teneligliptin in the treatment of adults with T2DM. In 12- or 16-week, placebo-controll...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-015-0348-9
更新日期:2015-11-01 00:00:00
abstract:PURPOSE:Deferiprone (DFP), deferasirox (DFX) and deferoxamine (DFO) are used in thalassaemia major (TM) patients to treat chronic iron overload. We evaluated the cost-effectiveness of DFP, compared with DFX and DFO monotherapy, from an Italian healthcare system perspective. METHODS:A Markov model was used over a time ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0496-1
更新日期:2017-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Oxycodone tamper resistant (OTR) is a new extended-release abuse-deterrent formulation providing improvements in the tamper resistant characteristics. This study aimed to investigate the pharmacokinetic properties of the new OTR tablets and evaluate the bioequivalence of oxycodone from OTR and...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-019-00870-w
更新日期:2020-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Bilastine is a novel second-generation antihistamine for the symptomatic treatment of allergic rhinitis and urticaria. The objective of this study was to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of bilastine following single and multiple oral doses in healthy Japanese ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-016-0447-2
更新日期:2016-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:TZP-101 is a selective, small molecule ghrelin receptor agonist in clinical development for the treatment of gastric motility disorders. The objectives of this study was to assess pharmacokinetic parameters of TZP-101 after multiple- and single-dose administration to healthy subjects and patien...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200929060-00004
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The new oral anticoagulants (NOACs) are used for the prevention of thromboembolic complications in patients with non-valvular atrial fibrillation (AF) and those at risk of deep venous thrombosis. Their rapid onset of action and predictable pharmacokinetic and pharmacodynamic profiles make them...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-016-0436-5
更新日期:2016-10-01 00:00:00
abstract::A specific beta(2)-adrenoceptor-mediated effect, hypokalaemia, was studied in healthy volunteers after single as well as multiple dosages of the long-acting agonist formoterol and the short-acting agent salbutamol. The purpose of the study was to test with simple methodologies if rapidly induced tachyphylaxis for this...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199815060-00009
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Polypharmacy, regarded as an indicator of potentially inappropriate medications (PIMs), may lead to a higher risk of serious health consequences in elderly patients with osteoporosis. Thus, this study aimed to analyze the association between polypharmacy and hip fracture in patients with osteop...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0716-3
更新日期:2019-01-01 00:00:00
abstract:BACKGROUND:Aliskiren is the first oral direct renin inhibitor to be approved for the treatment of hypertension. The pharmacokinetic and pharmacodynamic profile of aliskiren has been extensively characterized in Caucasian individuals; however, drug disposition, treatment response and tolerability can vary among ethnic g...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11533050-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Despite the introduction of Medicare Part D (MPD) and 2012 Affordable Care Act (ACA), patients have a cost burden due to increases in drug prices. To overcome cost barriers, some patients purchase their medications from Canadian online pharmacies as Canadian prescription drug prices are believ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0556-6
更新日期:2017-10-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Cancer pain affects patients at all stages of the disease and there are clear guidelines for its management. Morphine is considered the first-choice strong opioid in the treatment of moderate-to-severe pain; however, numerous studies have shown that oxycodone controlled-release (CR) has a simi...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
doi:10.2165/00044011-200828070-00001
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:Post-marketing surveillance studies can provide supplemental data on the safety of medications in the general population. OBJECTIVE:This study aimed to evaluate the safety of analgesic regimens including the NSAID lornoxicam in the short-term treatment of postoperative pain in a clinically relevant populati...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/11538860-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The optimal choice for first- and second-line antiseizure medications for pediatric patients with convulsive status epilepticus remains ambiguous. The present study aimed to estimate the comparative effect on the efficacy and safety of different antiseizure medications in pediatric patients wit...
journal_title:Clinical drug investigation
pub_type:
doi:10.1007/s40261-020-00975-7
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND:Urinary tract infection (UTI) is a leading cause of morbidity in the female population, with high levels of prevalence and recurrence within 6 months. OBJECTIVES:Our objective was to estimate annual costs and health resource utilization by women with UTIs, and the impact on quality of life (QoL) due to lowe...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-013-0069-x
更新日期:2013-04-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:A novel tiotropium bromide monodose capsule dry powder inhaler (DPI) formulation and device have been developed. The formulation was based on a spray-dried matrix that enhances the aerosolizaton properties, allowing a less active tiotropium metered dose (13 µg/capsule) while maintaining the sam...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-016-0441-8
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND:The use of budesonide/formoterol as both maintenance and reliever therapy in asthma is recommended in many countries; however, there are limited data available for the Asian patient population. OBJECTIVE:This study aimed to evaluate the short-term safety and tolerability of a fixed high-dose combination of ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11595440-000000000-00000
更新日期:2012-01-01 00:00:00
abstract::This article discusses current practice in the treatment of conjunctivitis and how the use of topical moxifloxacin can increase therapeutic effectiveness, reduce treatment failures and, consequently, be cost effective and reduce the societal burden of the disorder. Current practice and effectiveness data were derived ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11589020-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Sleep architecture changes with age, both in terms of efficiency and total duration of sleep. Hypnotic benzodiazepines promote rapid onset of sleep, uninterrupted sleep and longer duration of sleep in the absence of carryover sedation the following morning; therefore, these may be appropriate f...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200727050-00003
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Currently evidence about clinical and demographic predictors of response to newer antidepressants such as duloxetine is limited. This study aimed to investigate whether a number of predictors, particularly co-morbid anxiety disorders and anxious depression, are associated with clinical improve...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/11588800-000000000-00000
更新日期:2011-01-01 00:00:00
abstract::This narrative review summarises the benefits, risks and appropriate use of acid-suppressing drugs (ASDs), proton pump inhibitors and histamine-2 receptor antagonists, advocating a rationale balanced and individualised approach aimed to minimise any serious adverse consequences. It focuses on current controversies on ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-017-0519-y
更新日期:2017-07-01 00:00:00
abstract:OBJECTIVE:This open, prospective, non-interventional, non-randomised, multi-centre postmarketing surveillance study was conducted over a mean period of 13.9 weeks to assess the efficacy, safety and acceptance of acarbose in Chinese patients with type 2 diabetes mellitus and subjects with impaired glucose tolerance (IGT...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.2165/00044011-200727060-00003
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Inhaled corticosteroid (ICS)/long-acting beta(2)-agonist (LABA) combinations are the preferred maintenance therapy for adult asthma patients uncontrolled by ICS alone. Supporting data are largely from mixed populations of adolescents and adults, although ICS/LABA combinations are not approved f...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11533420-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Nonsteroidal anti-inflammatory drugs are effective analgesics but their use during tonsillectomy is controversial because of the risk of postoperative bleeding. The aim of this study was to compare the analgesic efficacy and safety of nimesulide, a preferential cyclo-oxygenase type-2 inhibitor,...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323100-00004
更新日期:2003-01-01 00:00:00