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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…

Efficacy of Single inhaler Maintenance And Reliever Therapy (SMART) with Spiromax® budesonide/formoterol versus fixed dose treatment with Diskus® fluticasone/salmeterol in COPD

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.

Handling oxygenation targets in adults with acute hypoxaemic respiratory failure in the intensive care unit: A randomised clinical trial of a lower versus a higher oxygenation target

To assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission.

A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging

The primary objective of the study is to evaluate the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic PAH.Secondary objectivesTo evaluate the safety and tolerability of macitentan in patients with…

AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS

Primary Safety Objective * Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602*2403 mg/d and nintedanib at a dose of 200*300 mg/d Secondary Safety Objective * Proportion of patients who discontinue…

Oral Versus Intravenous Dexamethasone in Community-acquired pneumonia study

To assess the bioequivalence of 6 mg dexamethasone tablet administered PO as an alternative to 5,26 mg dexamethasone-disodiumphosphate (= 4 mg dexamethasone) solution administered IV

The predictive value of the acute effect of montelukast on an exercise challenge test for the outcome of longterm treatment with montelukast

What is the correlation between change in % fall in FEV1 (*FEV1) after an exercise challenge 20h after a single dose of montelukast and after 4 weeks of treatment with montelukast?

Study evaluating ease of use, preference and satisfaction of two different Fluticason/salmeterol inhalers in asthma or COPD patients

To assess the percentage of COPD and asthma patients correctly (all critical items correct) using the Accuhaler/Diskus vs Elpenhaler inhaler devices after reading the package insert. Also satisfaction with and preference for an inhaler will be…

A Single-arm Open Label Study Evaluating the Impact on Lifestyle of a New Thermo-stable Formulation of Flolan in Subjects with Pulmonary Arterial Hypertension (PAH) (FLR115332)

Primary:* To describe the effect of the new thermo stable formulation of FLOLAN on quality of life in patients switching from the currently marketed FLOLAN to the new thermo stable formulation.* To determine the dose titration requirementSecondary…

Treatment in patients with recurrent infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response.

The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…

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.

Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis

Primary objective:To compare the change in small airways obstruction (FEF75%) in patients with CF when inhaling one ampule of inhaled tobramycin with the Akita® compared to standard of treatment (twice daily nebulization of one ampule using standard…

Reducing Apneas in Preterm Infants: Low-Flow versus Caffeine

The main objective of this study is to determine if Low-Flow is non inferior in reducing apneic spells compared to caffeine. Secondary objectives are investigating if these treatments have an effect on the need of supplemental ventilation and on the…

Multicenter randomized 2x2 cross-over study for patient satisfaction and function of the ProTrach DualCare

In this research we want to determine whether patients prefer the ProTrach DualCare over other speaking valves, if it improves quality of life, compliance with HME use and lung function.

A Multi Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after Transplantation

Primary objective: To show that the variability of whole blood total and unbound plasma tacrolimus concentrations during the first 6 days post transplantation is larger than the variation of tacrolimus concentrations in stable clinical situation.…

Video-assisted thoracic surgery versus open lobectomy for lung cancer: a randomized prospective trial

To compare quality of life, cost-effectivenessand number of dissected mediastinal lymph node as a derivative oncologic outcome between open- and VATS lobectomy.

The predictive value of the acute effect of beclomethasone on a mannitol challenge test for the outcome of longterm treatment with beclomethasone

What is the correlation between change in Mannitol PD15 (provoking dose of mannitol to cause a >= 15% fall in FEV1 ) 6h after a single dose of beclomethasone and after 4 weeks of treatment with beclomethasone?

Pneumonia treated with rifampicine attenuates inflammation

To primary objective is to demonstrate a reduction in lipoteichoic acid release in patients with pneumococcal pneumonia treated with rifampicin. This will be done by measuring lipoteichoic acid in serum and urine.Evaluable patients for Intention-to-…

Nocturnal Non-Invasive ventilation in COPD patients with stable hypercapnic respiratory failure: why and in which patient might this be effective?

Objectives: 1) To investigate change in FEV1 after 3 months nocturnal NIV in stable hypercapnic COPd patients as compared to standard care2) To investigate the relationship between FEV1 change and modification of systemic and airway inflammation and…

The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium
Bromide/Vilanterol in a Single Inhaler (TRELEGY ELLIPTA) when Compared
with Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients within a Usual
Care Setting.(study 206854)

Primary:To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT for the impact of COPDon wellbeing and daily life after 24 weeks* treatment. Secondary:To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT on lung…