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A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment with the Holaira* Lung Denervation System in Patients with Moderate to Severe COPD.

Phase A: To evaluate the safety and feasibility of the Holaira System at two energy levels in order to establish the optimal energy dose.Phase 2: To compare the safety and feasibility outcomes between the Holaira System vs. a Sham-control group…

The efficacy of Sonographic and biological pleurodesis Indicators of Malignant Pleural Effusion (SIMPLE) - a randomised trial

This trial will prospectively test the use of ultrasound imaging and pleural fluid analysis in improving the management of patients with malignant pleural effusion.Primary objective: Establish if the use of TUS before and during the first 24-72…

Study 117113: Mepolizumab vs. Placebo as add-on treatment for frequently exacerbating COPD patients characterized by eosinophil level

Primary: To evaluate the efficacy and safety of mepolizumab 100 mg and 300 mg subcutaneous given every 4 weeks compared to placebo on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations despite the use…

Dexamethasone in community-acquired pneumonia.

Primary Objective: - To confirm the effect of dexamethasone on clinical outcome in patients admitted with CAP.Secondary Objectives: - To study what patients admitted with CAP benefit most from dexamethasone therapy. Predefined subgroup analysis…

STATIC IV: Efficacy of a loading dose of intravenous salbutamol in patients admitted to a PICU for severe acute asthma

To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the…

What is the effect of steppen (stepping on and off at aerobicsstep) at quality of live, endurance, hospitalization stay and muscle strenght of the quadriceps and circumference of the calf muscles during hopitalized COPD exacerbation relative to the standard therapy?

The aim of the research is to understand the effect of steppen on the quality of life , opnameduur , endurance , muscle strength of quadriceps and circumference of the calf muscles against the standard treatment during a clinical COPD exacerbation…

MOSAIC-2 Study: MOdel to Study upper Airway Immunity upon Cholera vaccination

To investigate whether raw milk, pasteurized milk or ultra-heat treated (UHT) milk is able to enhance the systemic immune response as induced by oral cholera vaccination, in comparison to regular vaccination. Oral vaccination can also induce an…

The effect of an outreaching care programme on the number of hospitalisation days and readmissions in patients hospitalized two times or more in the previous 12 months.

Reducing the number of readmissions in the revolving door patients diagnosed with COPD by means of an outreaching care nurse.

Implementing Treatment Algorithms for the Cure of Trauma Induced Coagulopathy (iTACTIC)

The primary objective is to compare the haemostatic effect of VHA-guided transfusion strategy versus optimized CCT guided transfusion strategy in haemorrhaging trauma patients. The secondary objectives of the study are to determine the effects of…

A Phase 2b, Randomized, Controlled Trial Evaluating GS 5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is as follows:* To evaluate the effect of presatovir (GS-5806) on nasal RSV viral load in RSV positive LT recipients with acute respiratory symptomsThe secondary objectives of this study are as follows: * To…

A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION.

This study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone treatment (study treatments) in patients with advanced idiopathic pulmonary fibrosis (IPF) and intermediate or high probability of Group 3…

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract

The co-primary objectives of this study are as follows:* To evaluate the effect of presatovir (GS-5806) on RSV viral load and development of lower respiratory tract complication (LRTC) in RSV positive autologous or allogeneic HCT recipients with…

A randomised, double-blind, placebo-controlled, parallel-group, multi-centre 24-week study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe
eosinophilic asthma on markers of asthma control (study 200862, MUSCA)

Primary: To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) every 4 weeks versus placebo on health-related quality of life (HR-QoL) in adult and adolescent subjects with severe eosinophilic asthma. Secondary: To assess the effects of…

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid Use in Adults and Adolescents with Oral Corticosteroids dependent Asthma (TROPOS)

Primary objective:• To evaluate the effect of tralokinumab compared to placebo in reducing the prescribed, OCS maintenance dose in adult and adolescent subjects with asthma requiring chronic treatment with maintenance OCS in addition to ICS/LABA.…

A randomized, double-blind, double-dummy, parallel group, multicenter study of once daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, twice daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and twice daily Fluticasone Propionate 250 mcg Inhalation Powder in the treatment of persistent asthma in adults and adolescents already adequately controlled on twice-daily inhaled corticosteroid and long-acting beta2 agonist (study 201378)

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…

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

The primary objective of this study is as follows:* To evaluate the effect of presatovir on RSV viral load in autologous or allogeneic HCT recipients with an acute RSV lower respiratory tract infection (LRTI)The secondary objectives of this study…

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.

Human Exposure to RhinOvirus * Effect of a plant-based polysaccharide food supplement on upper respiratory symptoms

This study is designed to test if consumption of a vegetable extract as a food ingredient improves resistance to an experimental respiratory tract infection with RV16 in healthy volunteers.Primary Objective: * To test and quantify the effect of the…

A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)

The objective of the trial is to confirm efficacy and a favorable benefit-risk ratio for BIBF 1120 in the treatment of IPF at the dose of 150 mg bid compared to placebo.

ARTEMIS: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF).

The primary objective of this study is to determine if ambrisentan is effective in delaying disease progression and death in subjects with IPF.Secondary objectives include evaluation of the safety and effect of ambrisentan on development of…