Search results for "Dose-ranging study"
showing 4 items of 4 documents
Efficacy and tolerability of lasmiditan, an oral 5-HT1F receptor agonist, for the acute treatment of migraine : a phase 2 randomised, placebo-control…
2012
Lasmiditan (COL-144) is a novel, centrally acting, highly selective 5-HT(1F) receptor agonist without vasoconstrictor activity that seemed effective when given as an intravenous infusion in a proof-of-concept migraine study. We aimed to assess the efficacy and safety of oral lasmiditan for the acute treatment of migraine.In this multicentre, double-blind, parallel-group, dose-ranging study in 43 headache centres in five European countries, patients with migraine with and without aura and who were not using prophylaxis were randomly assigned (1:1:1:1:1) to treat one moderate or severe attack at home with 50 mg, 100 mg, 200 mg, or 400 mg lasmiditan, or placebo. Study drug and placebo were sup…
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…
A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison.
2008
This dose-ranging study assessed the bronchodilator efficacy and tolerability of indacaterol, a novel once-daily inhaled beta2-agonist, in subjects clinically diagnosed with COPD. Comparative data with tiotropium were collected. In the double-blind, core period of the study, 635 subjects with COPD (prebronchodilator FEV(1)40% of predicted and > or =1.0L; FEV1/FVC <70%) were randomized to receive indacaterol 50, 100, 200 or 400microg or placebo via multi-dose dry powder inhaler, or indacaterol 400microg via single-dose dry powder inhaler, once daily for 7 days. After completing double-blind treatment and washout, a subset of subjects from each treatment group entered an open-label extension …
Late Breaking Abstract - Dose-ranging study of mepolizumab in eosinophilic COPD
2018
Background: Patients with eosinophilic COPD & frequent exacerbations may benefit from mepolizumab (MEP) treatment. Objective: Assess efficacy & safety of 2 MEP doses vs placebo (PBO) in COPD with blood eosinophils ≥150 cells/µL [screening] or ≥300 cells/µL [prior yr], history of ≥2 moderate/≥1 severe exacerbations & ICS+≥2 bronchodilator maintenance therapies (ICS+MT). Methods: Phase III, randomised, PBO-controlled, double-blind, parallel-group trial (METREO); patients received SC MEP 100mg, MEP 300mg or PBO plus ICS+MT, every 4 wks for 52 wks. Primary endpoint: rate/yr of moderate (systemic corticosteroids/antibiotics)/severe(hospitalisation or death) exacerbations. Secondary endpoints inc…