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Tidal ventilation distribution and patient-ventilator synchrony during Proportional Assist Ventilation with load-adjustable gain factors

To compare the tidal volume distribution and other ventilator parameters between PAV+ and NAVA.

A 26-week, randomized, double blind, parallel-group multicenter study to assess the efficacy and safety of QVA149 (110/50 mcg o.d.) vs tiotropium (18 mcg o.d.) + salmeterol/fluticasone propionate FDC (50/500 mcg b.i.d.) in patients with moderate to severe COPD

The purpose of this study is to determine whether the efficacy and safetyof QVA149 (110/50 *g o.d.) and triple treatment with tiotropium (18 *go.d.) + salmeterol/fluticasone propionate FDC (50/500 *g b.i.d.) arecomparable in patients with moderate…

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the Test-of-Cure (TOC0 visit…

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 Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Lefamulin (BC 3781) Versus Moxifloxacin (With or Without Adjunctive Linezolid) in Adults With Community-Acquired Bacterial Pneumonia

The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…

A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment

Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…

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…

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…

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 2, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of
Inhaled JNJ-49095397 (RV568) in Subjects With Moderate to Severe Chronic Obstructive
Pulmonary Disease

Primary ObjectiveThe primary objective is to assess the efficacy (as measured by change from baseline in prebronchodilator [preBD] percent predicted forced expiratory volume in one second [FEV1]) of JNJ-49095397 compared with placebo in subjects…

Addition of Tobramycin inhalation antibiotic treatment to standard IV antibiotic treatment for ventilator-associated pneumonia

Does addition of inhalation tobramycin to standard IV treatment result in a higher clinical cure rate than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia.The initial response to treatment will be evaluated…

MOSAIC study:
MOdel to Study upper Airway Immunity upon Cholera vaccination

To investigate whether raw milk is able to enhance the upper airway immune response as induced by oral cholera vaccination.

Effect of Carbon Nanoparticles on Inflammation and Coagulation after Bronchial Segmental Instillation. A dose escalation study

We will investigate the local and systemic effects of carbon nanoparticles on inflammation and coagulation in humans by bronchial segmental challenge

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

A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray (FFNS) 110 mcg, administered either once daily or twice daily, compared with placebo, as effective monotherapy in the treatment of uncomplicated acute rhinosinusitis (ARS) in adult and adolescent subjects 12 years of age and older.

The objective of this study is to evaluate the safety and efficacy of two doses of FFNS (110 mcg once daily and 110 mcg twice daily) compared to placebo as monotherapy in the treatment of adult and adolescent subjects 12 years of age and older with…

A multi-center, randomized, double-blind, placebo-controlled, parallel group, repeated-dose study to evaluate the efficacy, safety, tolerability and pharmacokinetics of three different dosing regimens of inhaled indacaterol maleate in patients with persistent asthma

The purpose of this study is to give more information about indacaterol in similar doses but given either once a day, twice a day, or once every other day to patients with persistent asthma.

Exercise training in patients with COPD

To quantify the effectiveness of one- legged exercise training in improving functional status of patients with COPD in comparison to two- legged exercise training during a 10 week pulmonary rehabilitation programme.

A randomized, double-blind, placebo-controlled first time into human study to
investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of intranasal dosing with GSK2245035, a TLR7 agonist, in healthy volunteers and allergic rhinitics

Part 1Primary:- to evaluate the safety and nasal tolerability of single escalating i.n. GSK2245035 doses in HVSecondary:- to evaluate the systemic PK of single i.n. GSK2245035 administration in HV- to evaluate the induction of TLR7-associated PD…

A multicenter randomised study in which operative stabilization of rib fractures with a flail chest is compared with mechanical ventilation.

The Purpose of this study is to compare the surgical treatment of flail chest with the non-operative treatment regarding complications.Hypothesis: Surgical stabilization of rib fractures in flail chest results in fewer respiratory complications,…

Phase I, single-centre, randomised, placebo-controlled, double-blinded study, with single ascending dose and multiple dose at maximum tolerated dose, evaluating the safety, tolerability and pharmacokinetics of ALX-0171, administered by pulmonary inhalation, in healthy male volunteers

- to determine the safety and tolerability of escalating single doses and multiple doses of ALX-0171- to evaluate the dose-limiting toxicity (DLT) level of ALX-0171 and determine the maximum tolerated dose (MTD)- to evaluate the PK of escalating…