Search results for "Crossover study"
showing 10 items of 161 documents
Tiotropium Respimat® in asthma: a double-blind, randomised, dose-ranging study in adult patients with moderate asthma
2013
Tiotropium, a once-daily long-acting anticholinergic bronchodilator, when administered via Respimat® SoftMist™ inhaler (tiotropium Respimat®) significantly reduces the risk of severe exacerbations and improves lung function in patients with severe persistent asthma that is not fully controlled despite using inhaled corticosteroids (ICS) and long-acting β2-agonists. To further explore the dose–response curve in asthma, we investigated the efficacy and safety of three different doses of tiotropium Respimat® as add-on to ICS in symptomatic patients with moderate persistent asthma. In this randomised, double-blind, placebo-controlled, four-way crossover study, patients were randomised to tiotro…
Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: The BRIGHT study
2014
Summary Introduction QVA149 is a novel, inhaled, once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β 2 -agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium (NVA237), for the treatment of chronic obstructive pulmonary disease (COPD). This study evaluated the effects of QVA149 on exercise tolerance, hyperinflation, lung function and lung volumes versus placebo and tiotropium. Methods Patients with moderate-to-severe COPD were randomized to QVA149 110/50 μg, placebo or tiotropium 18 μg once daily in a blinded, 3-period crossover study for 3 weeks. The primary endpoint was exercise endurance time at Day 21 for QVA149 versus placebo. R…
Preference for Rizatriptan 10-mg Wafer vs. Eletriptan 40-mg Tablet for Acute Treatment of Migraine
2006
Preference is a composite, patient-oriented endpoint incorporating efficacy, tolerability, formulation, and convenience of medications. The objective of this study was to compare patient preference for rizatriptan 10-mg wafer vs. eletriptan 40-mg tablet for acute treatment of migraine. In this multicentre, open-label, two-period, crossover study, out-patients were randomly assigned to treat the first of two moderate to severe migraines with rizatriptan or eletriptan and the second with the alternate therapy. Patients completed diary assessments at baseline and up to 24 h after taking study medication. At the last visit, patients completed a psychometrically validated preference questionnai…
Pharmacokinetics of dabigatran etexilate and rivaroxaban in patients with short bowel syndrome requiring parenteral nutrition: The PDER PAN study
2017
Background and aims: Patients on parenteral nutrition for short bowel syndrome (SBS) have a high risk of thrombotic complications and are often treated with parenteral anticoagulation. Direct oral anticoagulants are absorbed proximally in the digestive tract and may represent alternative regimens in selected SBS patients. In our pilot study, we provided pharmacokinetics parameters of dabigatran etexilate and rivaroxaban in this setting and compared peak (Cmax), trough (Ctrough) concentrations, and areas-under-the-concentration-time-curve (AUC(0) (-) (t)) to reference values retrieved from phase I-III studies. Methods: We enrolled 6 adults with a remaining small bowel length <= 200 cm, norma…
Transcranial direct current stimulation of the motor cortex induces distinct changes in thermal and mechanical sensory percepts
2009
Abstract Objective The aim of this single-blinded, complete crossover study was to evaluate the effects of tDCS on thermal and mechanical perception, as assessed by quantitative sensory testing (QST). Methods QST was performed upon the radial part of both hands of eight healthy subjects (3 female, 5 male, 25–41 years of age). These subjects were examined before and after cathodal, anodal or sham tDCS, applied in a random order. TDCS was administered for 15 min at a 1 mA current intensity, with the active electrode placed over the left primary motor cortex and the reference electrode above the right orbit. Results After cathodal tDCS, cold detection thresholds (CDT), mechanical detection thr…
Acute stress impairs recall after interference in older people, but not in young people.
2013
Stress has been associated with negative changes observed during the aging process. However, very little research has been carried out on the role of age in acute stress effects on memory. We aimed to explore the role of age and sex in the relationship between hypothalamus-pituitary-adrenal axis (HPA-axis) and sympathetic nervous system (SNS) reactivity to psychosocial stress and short-term declarative memory performance. To do so, sixty-seven participants divided into two age groups (each group with a similar number of men and women) were exposed to the Trier Social Stress Test (TSST) and a control condition in a crossover design. Memory performance was assessed by the Rey Auditory Verbal …
Relative sensitivity of four noninvasive methods in assessing systolic cardiovascular effects of isoproterenol in healthy volunteers.
1992
Study objective The study was performed to evaluate the relative sensitivity of various noninvasive methods to detect and describe the systolic cardiovascular effects of stepwise increasing doses of isoproterenol: two-dimensional left ventricular echocardiography (main variable, ejection fraction), ACVF (attenuation compensated volume flow)–dual-beam Doppler echoaortography (time-averaged mean velocity), electrical impedance cardiography [(dZ/dtmax)/RZ index], and systolic time intervals from mechanocar-diography (PEP and QS2c). Methods Isoproterenol was administered by constant rate intravenous infusion in consecutive steps of 0.1, 0.2, 0.4, 0.75, and 1.5 µg/min (each for 15 minutes). Sali…
The effects of sugar-free chewing gums on dental plaque regrowth: a comparative study
2006
Abstract Sugar-free chewing gum has been claimed to be a useful means of reducing dental plaque accumulation. The incorporation of additives, such as enzymes, abrasives and divalent metal ions, into gum formulations might improve their antiplaque activity, particularly at the buccal and lingual surfaces of the teeth. Objectives The aim of this study was to investigate the plaque inhibitory effects of three sugar-free chewing gums each containing lactoperoxidase (LP), micro granules of silicon dioxide (SD), and zinc gluconate (ZG). Methods The study was an observer-masked, randomized cross-over design balanced for carryover effects, involving 12 healthy volunteers in a 4-day plaque regrowth …
Plaque removal efficacy of power and manual toothbrushes: a comparative study
2009
The aim of this study was to compare the plaque removal efficacy of a new oscillating/rotating/pulsating toothbrush [Oral-B® Professional Care® 8500 (PC 8500)] with two manual toothbrushes [Oral-B® CrossAction™ Vitalizer (CAV) and Oral-B® Indicator™ (IND), respectively]. The safety of the PC 8500 was also assessed. The study was a single-use, observer-masked, randomised 3×3 Latin square crossover design balanced for carryover effects. The enrolled subjects (n=66) refrained from brushing for 23–25 h before each clinical examination. Plaque scores were recorded before and after brushing with the allocated toothbrush using the Turesky et al. modification of the Quigley and Hein plaque index. T…
Efficacy of 3 toothbrush treatments on plaque removal in orthodontic patients assessed with digital plaque imaging: a randomized controlled trial.
2013
Good oral hygiene is a challenge for orthodontic patients because food readily becomes trapped around the brackets and under the archwires, and appliances are an obstruction to mechanical brushing. The purpose of this study was to compare plaque removal efficacy of 3 toothbrush treatments in orthodontic subjects.This was a replicate-use, single-brushing, 3-treatment, examiner-blind, randomized, 6-period crossover study with washout periods of approximately 24 hours between visits. Forty-six adolescent and young adult patients with fixed orthodontics from a university clinic in Germany were randomized, based on computer-generated randomization, to 1 of 3 treatments: (1) oscillating-rotating …