18 results
Primary objective: To demonstrate the superiority of QVA 110/50 µg compared to both QAB149 150 µg and NVA237 50 µg in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose) following 26 weeks of treatment in patients with moderate to…
Efficacy and safety.
To demonstrate the superiority of indacaterol 150 µg o.d. in combination with tiotropium 18 µg o.d. versus tiotropium 18 µg o.d. with respect to standardized area under the curve (AUC) for forced expiratory volume in 1 second (FEV1) between 5 min *…
In preparation for a large multi-center trial on the efficacy and safety of SENS for chronic intractable angina pectoris, we want to conduct a pilot, explorative trial to assess the feasibility, safety and efficacy of SENS implantation in this…
To demonstrate superiority of tiotropium vs. salmeterol in reducing exacerbations which are an important patient outcome because they are a major cause of morbidity from COPD. In addition, they are associated with a more rapid decline in lung…
The study is designed to compare the 24-h spirometry profile of two doses of indacaterol (150o.d. and 300 *g o.d.) with that of placebo (o.d.) and with tiotropium (18 *g o.d.) as an activecontrol in patients with COPD.
This study is designed to demonstrate non inferiority of 150 *g o.d. of indacaterol versus tiotropium 18 *g o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment.
Primary objective: To demonstrate that QVA149 (110/50 *g o.d.) is superior to NVA237 (50 *g o.d.) with regard to the rate of moderate to severe COPD exacerbations during 64 weeks of treatmentSecondary objectives: To demonstrate that QVA149 (110/50 *…
With intervention with bronchodilators (usual care bronchodilators for COPD subjects), in one study histamine and in one study steroids, we want to investigate the respons on inspiratory lung function parameter like the FIV1 and also investigate…
Primary Objective:To evaluate the efficacy and safety of 2 doses of benralizumab in patients with moderate to very severe Chronic Pulmonary Disease (COPD).Secondary Objectives:To evaluate the effect of two doses of benralizumab on:* health status/…
The objective of this Phase 3 study is to investigate the safety and efficacy of benralizumab as a treatment for patients with eosinophilic gastritis and/or gastro-enteritis.
To determine the effect of benralizumab on the rate of asthma exacerbationsSubstudy: - To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen whilemaintaining asthma control.- To assess…
To test the hypothesis: the mode of action of benralizumab being ADCC will target both resident and inflammatory eosinophils whereas mepolizumab only targets inflammatory eosinophils. This will achieved by a head-to-head comparison of the presence…
To evaluate the effect of benralizumab 100 mg on COPD exacerbations in patients with moderate to very severe COPD.
To evaluate the efficacy of GSK3511294 100 mg (SC) every 26 weeks versus maintaining existing treatment with either mepolizumabor benralizumab in participants with severe asthma with an eosinophilic phenotype who have previously benefited from anti-…
The objective of this Phase 3 study is to investigate the safety and efficacy of benralizumab as a treatment for patients with eosinophilic esophagitis.
To test the hypothesis: the mode of action of benralizumab being ADCC will target both resident and inflammatoryeosinophils whereas mepolizumab only targets inflammatory eosinophils. This will achieved by a head-to-headcomparison of the presence of…
This research proposal aims to assess the anti-inflammatory effects after 6 weeks treatment with tiotropium compared to placebo in patients with stable COPD.