19 results
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…
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
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…
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…
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. .
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…
Efficacy and safety.
Primary Objective:Efficacy:· Evaluate the efficacy of subcutaneous (sc) azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in the defined study population.Secondary Objectives:Safety:· Assess the safety and…
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.
Part 1:The purpose of Part 1 of the study is to investigate how much of the OZ439 compound is absorbed into, distributed in, and eliminated from the body (this is called pharmacokinetics) when administered orally as compared to an intravenous (iv;…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
The aim of this study is to investigate the use of cobicistat to reduce the required dose and dose frequency of tofacitinib in the treatment of RA.
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
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…
Part APrimary objective1. To determine the equivalence of the Area-Under-the-Curve (AUC) of the reduced, boosted dose of olaparib and the regular dose.Secondary objectives1. To determine whether boosting reduces the inter- and intrapatient PK…
The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is enhanced when osimertinib is co-administered with cobicistat in patients with relatively low blood concentrations while receiving the standard…