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Lung Volume Reduction Coil for Treatment in Patients with Emphysema (RENEW) Study

The primary objective of this study is to determine whether treatment with the RePneu LVRC System results in improved exercise capacity and quality of life, as measured by improvements in the 6 Minute Walk Test (6MWT).

A randomized, parallel group study to evaluate the effect of Umeclidinium (UMEC) added to Inhaled corticosteroid/ long-acting beta-agonist combination therapy in subjects with Chronic Obstructive Pulmonary Disease COPD (study 201314)

Primary: efficacy and safety of the addition of UMEC 62.5mcg once daily to ICS/LABA therapy, compared with placebo over 12 weeks in subjects with COPD.Secondary: effect of the addition of UMEC to ICS/LABA therapy on COPD-related health status…

Multi-centre, randomized, double-blind, parallel-group study evaluating the effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder once daily compared with Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in subjects with Chronic Obstructive Pulmonary Disease (COPD) (HZC102972)

Effect on bone mineral density.

A randomised, double-blind (sponsor unblinded), placebocontrolled, parallel-group, multicentre study to evaluate the efficacy and safety of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease (PII116678)

Primary: To evaluate the effect of once daily repeat inhaled doses of GSK2269557 on lung parameters derived from HRCT scans in subjects with acute exacerbation of COPD,compared to placebo. Secondary: Other lung parameters derived from high…

A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD.

The aim of this study is to demonstrate that once daily treatment with tiotropium + olodaterol fixed dose combination will reduce the number of exacerbations over tiotropium 5 µg monotherapy.A secondary aim of the study is an assessment of a…

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…

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…

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 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.

Effect of roflumilast on exacerbation rate in patients with COPD treated with fixed combinations of LABA and ICS. A 52-week, randomised double-blind trial with roflumilast 500 µg versus placebo.

* To investigate the effect of roflumilast 500 µg tablets once daily versus placebo on exacerbation rate, and pulmonary function and major adverse cardiovascular events (MACE) in COPD patients who are concomitantly treated with a fixed combination…

An explorarory, 12 week, randomised, partially double-blinded, placebo-controlled parallel group trial to explore the effects of once daily treatments of orally inhaled tiotropium + olodaterol fixed dose combination or tiotropium (both delivered by Respimat® inhaler), supervised exercise training and behavior modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD)

The primary objective is to confirm that bronchodilator monotherapy (tiotropium) plus behavioural modification, bronchodilator combination therapy (tiotropium + olodaterol FDC) plus behavioural modification, and bronchodilator combination therapy (…

A randomized, double-blind, placebo-controlled intervention study to assess the therapeutic effect of an extensively hydrolyzed infant formula with an added synbiotic mixture in infants with atopic dermatitis.

2.1 Primary study objectiveThe primary objective of this study is to investigate the therapeutic effect of an extensively hydrolyzed protein based infant formula with a synbiotic mixture on the severity of atopic dermatitis in infants.2.2 Secondary…

A randomized, double blind, placebo controlled, multi-centre study to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in chronic obstructive pulmonary disease patients with cachexia (CBYM338X2204)

Primary: Assess the effect of i.v. infusions of BYM338 on muscle volume of the thigh (assessed by MRI) at 4, 8, 16 and 24 weeks, compared to placebo, in COPD patients with pulmonary cachexia.Secondary: Effect on 6-minute walk test, safety and…

Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin versus Placebo in Burn Patients with Inhalation Trauma

The aim of this project is to address whether nebulized heparin:1) increases the number of ventilator*free days during 28*days in burn patients with inhalation trauma2) improves lung injury scores in burn patients with inhalation trauma3) reduces…

Pulmonary Rehabilitation of COPD: a trial of sustained internet based self-management support

Research QuestionWhat is the long-term effectiveness and cost-effectiveness of self-management support via an internet based service in addition to usual care as compared to usual care alone in patients with COPD who have completed pulmonary…

Sinusoidal Compared With Constant Work Rate High Intensity Exercise Training In COPD Patients With Ventilatory Limitation

The primary outcome measure will be comparison of improvement in endurance of a work rate initially eliciting exercise limitation after 6 minutes (calculated from the power-duration relationship before and after training). We will also compare…

Prevention of atelectasis in the preoxygenation phase: comparison of two different oxygenation strategies

To assess if preoxygenation with 100% O2 or preoxygenation with 100% O2 and PEEP are different with respect to the development of atelectasis as determined by lung computed tomography.

A 52-week treatment, multi-center, randomized, doubleblind, double dummy, parallel-group, active controlled study to compare the effect of QVA149 (indacaterol maleate / glycopyrronium bromide) with salmeterol/fluticasone on the rate of exacerbations in subjects with moderate to very severe COPD (CQVA149A2318)

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…

A randomized, double-blind, parallel group, 52-week study evaluating the efficacy, safety and tolerability of NVA237 in patients with poorly controlled asthma (CNVA237B2301)

Primary: To demonstrate the superiority of NVA237 50 *g o.d. compared to placebo in addition to background therapy with long acting B2 agonist/ inhaled corticosteroid (* 800 *g/day of budesonide or equivalent) in terms of trough FEV1 after 26 weeks…