16 results
Section 7 of the protocol:7. TRIAL OBJECTIVES AND PURPOSE* To assess the long term bronchodilator efficacy of Aclidinium bromide/Formoterol fumarate, administered twice a day, compared to Salmeterol/Fluticasone propionate (SeretideTM AccuhalerTM) in…
Primary objective: To demonstrate that QVA149 (110/50 *g o.d.) is at least non-inferior to salmeterol/fluticasone (50/500 *g b.i.d.) in terms of rate of COPD exacerbations.Secondary objectives: Superiority in terms of exacerbation rate. Time to…
Primary: To demonstrate non-inferiority of RELVAR 100/25 once-daily to SERETIDE 250/50 twice-daily in adult and adolescent subjects 12 years of age and older with persistent asthma,adequately controlled on twice-daily ICS/LABA. Secondary: Adverse…
This research proposal aims to investigate the efficacy of the SMART approach with budesonide/fomoterol versus fixed dose treatment with fluticasone/salmeterol in patients with COPD.
The primary objective of the study is to evaluate whether the addition of LABA to ICS therapy (FSC) is non-inferior to ICS therapy alone (FP) in terms of the risk of serious asthma related events (asthma-related hospitalization, endotracheal…
The primary objective is to evaluate whether the addition of a LABA to an ICS (FSC) therapy is non-inferior in terms of risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) compared with ICS…
Efficacy and safety.
The objective of this study is to obtain information regarding the effectiveness and safety of a product called Foster® for the treatment of asthma. This product is a combination between two well known drugs: formoterol fumarate and beclomethasone…
Compare if once daily laba/lama treatment with two different dosages shows the same or better result on the 24 hr lungfunction than twice daily treatment of two different dosages with ICS/laba treatment. .
This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in patients of all ages with mild (FVIII level between > 5% and < 40%) or moderate hemophilia A (FVIII level between >= 1% and…
Investigate the effects of 7 (+-1) days of of mono- and combination therapy with the SGLT2 inhibitor empagliflozin (10 mg QD) and RAS inhibitor losartan (50 mg QD) on renal hemodynamics, (glomerular filtration rate (GFR) / effective renal plasma…
We aim to investigate the renal hemodynamic effects of empagliflozin in people with either preserved or impaired renal function with T2DM and people with impaired renal function without T2DM, all with and without adenosine blockade.
Study MO41787 will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at 3 mg/kg Q2W for a period of 52 weeks in previously untreated patients (PUPs) and minimally treated patients (MTPs) at study…
To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 *g o.d. and 150/50/80 *g o.d. compared to a FDC ofsalmeterol/fluticasone at a dose of 50/500 *g b.i.d. after 3 weeks of treatment in patients with asthma.
The purpose of the trial is to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 *g and QVM149 150/50/160 *g via Concept1) over two respective QMF149 doses (QMF149 150/160 *g and QMF149 150/320 *g via Concept1 in…
Primary objectiveTo determine whether individualized pharmacokinetic (PK)-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the - proportion of patients without treated bleeds (6 months before and after intervention…