Search results for "Placebo"

ONCE-DAILY INDACATEROL PROVIDES SUPERIOR BRONCHODILATION, HEALTH STATUS AND CLINICAL OUTCOMES COMPARED WITH SALMETEROL IN PATIENTS WITH CHRONIC OBSTR…

2009

Efficacy and safety of indacaterol and tiotropium in COPD patients according to dyspnoea severity.

2013

Background Guidelines for chronic obstructive pulmonary disease (COPD) recommend that treatment choices be based partly on symptoms. Methods A post-hoc analysis of pooled data from clinical studies compared the efficacy and safety of once-daily inhaled bronchodilators indacaterol (150 and 300 μg) and open-label tiotropium (18 μg) according to baseline dyspnoea severity on the modified Medical Research Council (mMRC) scale in patients with COPD (mMRC scores <2 = ‘less dyspnoea’; scores ≥2 = ‘more dyspnoea’). Outcomes were assessed after 26 weeks. Results The analysis included 3177 patients. In patients with less dyspnoea: indacaterol (both doses) improved 24-h post-dose (‘trough’) forced exp…

Comparative efficacy of levocetirizine, desloratadine, clemastine, kvifenadine and sekvifenadine on histamine prick test induced weal reaction, blood…

2007

Effect of ketotifen on the bronchodilation induced by salbutamol.

1988

Twelve subjects with stable asthma each inhaled two puffs (200 micrograms) of salbutamol on 2 separate days 3 h after double-blind oral administration of ketotifen (two 1-mg capsules) or identical placebo. FEV1 was recorded before and at intervals for 4 h after inhalation of salbutamol. Overall, the FEV1 was significantly greater during the 4-hour period after premedication with ketotifen (p less than 0.02) and the difference between the effect of placebo and ketotifen was statistically significant at 120, 180 and 240 min after salbutamol (p less than 0.05).

Effect of multiple honey doses on non-specific acute cough in children. An open randomised study and literature review.

2015

Abstract Background Honey is recommended for non-specific acute paediatric cough by the Australian guidelines. Current available randomised clinical trials evaluated the effects of a single evening dose of honey, but multiple doses outcomes have never been studied. Objectives To evaluate the effects of wildflower honey, given for three subsequent evenings, on non-specific acute paediatric cough, compared to dextromethorphan (DM) and levodropropizine (LDP), which are the most prescribed over-the-counter (OTC) antitussives in Italy. Methods 134 children suffering from non-specific acute cough were randomised to receive for three subsequent evenings a mixture of milk (90 ml) and wildflower hon…

Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe…

2021

Background: ANDHI was done to assess the efficacy of benralizumab, including onset of effect and impact on health-related quality of life (HRQOL), exacerbation rate, lung function, and nasal polyposis symptoms. Methods: This phase 3b, randomised, double-blind, parallel-group, placebo-controlled ANDHI study was completed in adults (aged 18–75 years) with severe eosinophilic asthma with at least 2 exacerbations in the previous year, despite high-dose inhaled corticosteroid plus additional controllers, screening blood eosinophil counts of at least 150 cells per μL, and an Asthma Control Questionnaire 6 (ACQ-6) score of 1·5 or more. Patients who met eligibility criteria were randomly assigned (…

P191 QVA149 once daily improves exercise tolerance and lung function in patients with moderate to severe COPD: the BRIGHT study: Abstract P191 Table 1

2012

Introduction QVA149 is a novel once-daily fixed-dose combination of the long-acting β 2 -agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium (NVA237) in development for the treatment of chronic obstructive pulmonary disease (COPD). The BRIGHT study evaluated the effects of QVA149 versus placebo and tiotropium on exercise tolerance and lung function in patients with moderate-to-severe COPD. Methods In a double-blind, double-dummy, 3-period crossover study, patients with moderate-to-severe COPD were randomised to QVA149 110/50 µg, placebo or tiotropium 18 µg once daily for 3 weeks. The primary endpoint was exercise endurance time for QVA149 versus placebo during a sub…

Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial

2015

Summary Background Interleukin 13 is a central mediator of asthma. Tralokinumab is a human interleukin-13 neutralising monoclonal antibody. We aimed to assess the efficacy and safety of two dosing regimens of tralokinumab in patients with severe uncontrolled asthma. Methods We did a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 2b study at 98 sites in North America, South America, Europe, and Asia. Patients aged 18–75 years with severe asthma and two to six exacerbations in the previous year were randomly assigned (1:1), via an interactive voice-response or web-response system, to one of two dosing regimen groups (every 2 weeks, or every 2 weeks for 12 wee…

Stratification of eosinophilic asthma patients treated with reslizumab and GINA Step 4 or 5 therapy

2017

Reslizumab, an anti-interleukin-5 monoclonal antibody, significantly reduces exacerbation frequency and improves lung function, asthma control and quality of life in adults with severe eosinophilic asthma, as demonstrated in Phase III studies. This secondary analysis assessed reslizumab's efficacy in patients receiving baseline treatment per Global Initiative for Asthma (GINA) Step 4 and Step 5 guidelines. Pooled data from duplicate, Phase III, reslizumab versus placebo studies in patients with severe eosinophilic asthma (blood eosinophils ≥400 cells·µL−1) were stratified by baseline therapy. Efficacy assessments were exacerbation rates and changes from baseline forced expiratory volume in …

Response to mepolizumab treatment is sustained across 4-weekly dosing periods

2020

Background Mepolizumab (100 mg delivered s.c. every 4 weeks) is indicated for add-on maintenance treatment for patients with severe eosinophilic asthma. Mepolizumab has been shown to reduce exacerbations and the requirement for daily oral corticosteroids, and improve asthma control and symptoms. However, data on the durability of the response to mepolizumab during dosing periods are limited. The aim of this study was to investigate the efficacy profile in patients with severe eosinophilic asthma over the 4-weekly dosing period for various fixed mepolizumab doses. Methods This was a post hoc analysis of data from the phase IIb/III DREAM study. Patients ≥12 years of age with severe eosinophil…