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A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF)

The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…

Ketanest in Intensive Care Unit Patients

Compare induction of anaesthesia using etomidate versus ketanest on hemodynamics, as well as microcirculatory consequences in patients admitted to the ICU and in need of ventilatory support.

A new dosing strategy of infliximab versus standard dosing in patients with severe sarcoidosis: optimization of treatment

Objective: To determine whether serum concentration guided dosing of infliximab is not inferior to standard dosing based on bodyweight in patients with severe sarcoidosis in terms of FVC change at 26 weeks.

A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS

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…

A randomized multi-center, double-blind, placebo-controlled, parallel-group trial to explore the effects of 78 week omalizumab treatment given as add on therapy on markers of airway inflammation and remodeling in patients with moderate to severe persistent allergic asthma receiving inhaled corticosteroids and long acting beta-agonists.

* Primary objective: To determine the effect of 78-weeks therapy with omalizumab compared to placebo on the number of sub-epithelial eosinophils, a marker of airway inflammation, in patients with persistent moderate to severe allergic asthma. *…

The protective effect of azelastine/fluticasone propionate (Dymista) on exercise-induced airway obstruction

To analyze the protective effect of azelastine/fluticasone propionate against exercise-induced airway narrowing by measuring inspiratory and expiratory airflow limitation and airway resistance and reactance in asthmatic children.

COrrelating plasma Nintedanib COncentRations with efficacy and toxicity in patients with interstitial lung DIseAse

To further research nintedanib PK and correlate them with clinical parameters and toxicity. Results could be used to optimize treatment of nintedanib in the future by dose individualization based on patient*s characteristics or therapeutic drug…

The effects of enoximone in acute exacerbation COPD: a pilot study

Primary Objective: a reduction in bronchoconstriction, measured by auto-PEEP, in patients with AE-COPD. Secondary Objective(s): * To test for a dose-dependency. * Decrease in pulmonary artery pressures* Enhance cardiac output* Measure occurrence of…

Population pharmacokinetics of mycophenolate mofetil in autoimmune diseases

Primary objective: to investigate MPA exposure in a variety of autoimmune diseases in stable treated patients. Secondary objective: to develop predictive exposure models and evaluate the influence of population covariables on pharmacokinetics .The…

A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging. (RESTORE)

Main objective:To assess the effects of selexipag on right ventricular (RV) function in participants with PAH.Secondary objectives:- To further assess the effects of selexipag on RV function using MRI.- To assess the effects of selexipag on disease…