19 results
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…
Our primary objective is to determine whether blocking of IL-1 by recombinant human IL-1ra (anakinra) in insulin resistant patients improves insulin sensitivity. Secondary objectives are to determine the effect of IL-1 blockade on pancreatic beta-…
Determine whether blockade of IL-1 had positive effects on insulin sensitivity in type 1 diabetic subjects without residual beta cel function
Primary objectives: To assess the ability of dabrafenib + trametinib treatment to downsize melanoma tumor masses to enable R0-resection. Secondary objectives: Recurrence free survival; time-to-next treatment, overall survival.
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. .
Efficacy and safety.
The primary objective is to evaluate the safety and efficacy of anakinra in patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (SCT). Secondary objectives…
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.
To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with…
To investigate the effect on symptomatology of interference with IL-1 in CFS patients.
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: superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib-placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-…
The primary aim of this research is to demonstrate the noninferiority of anakinra compared with the standard of care in the treatment of acute gout flares.Secondary objectives are to compare the cost per quality-adjusted life day between anakinra…
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…
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.
Primary: overall response rate.Secondary: progression free survival, duration of response, overall survival, safety, tolerability, pharmacokinetics (PK).
* Safety Run inTo determine the recommended regimen of PDR001 in combination with dabrafenib and trametinib for the randomized part (part 3)* Biomarker cohortTo evaluate changes in the immune microenvironment and biomarker modulations upon treatment…