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A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve (EBV)
Therapy vs. Standard of Care (SoC) in Heterogeneous Emphysema.

To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using the Pulmonx Zephyr Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subject in a controlled trial design setting.

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…

Proactive treatment of collateral ventilation in CV-positive emphysema patients
before EBV treatment.

Primary objective: 1. To investigate the feasibility of injecting autologeous blood or blood derived products into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.Secondary…

Multi-arm, Non-randomized, Open-Label Phase IB Study to Evaluate GSK3052230 in Combination with Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects with Solid Malignancies and Deregulated FGF Pathway Signaling (FGF117360)

Primary: to characterize the safety and tolerability of GSK3052230 in combination with chemotherapy regimens, to determine the MTD and to assess overall response rate in patients with stage IV or recurrent squamous NSCLC with FGFR1 gene…

A clinical study to evaluate the safety, tolerability, and pharmacokinetics of the MMP 12 inhibitor FP- 025 after multiple oral ascending dose administration, and to evaluate the effect of food after a single oral dose administration in healthy subjects

Primary* To determine the safety and tolerability of multiple oral ascending doses of FP 025 in healthy subjects.Secondary* To determine the pharmacokinetics (PK) of FP 025 after multiple oral ascending doses of FP 025 in healthy subjects.* To…

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.

PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients - The PROBESE Randomized Controlled Trial

To compare a ventilation strategy using higher levels of PEEP with recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in obese patients at an intermediate-to-high risk for PPCs.We hypothesize that an intra-…

PRotective VENTilation in Patients not Fulfilling the Consensus Definition for Moderate or Severe ARDS at Start of Ventilation * PReVENT, a Randomized Controlled Trial

The present study aims at comparing a ventilation strategy with a lower tidal volume and a higher respiratory rate with ventilation using a higher tidal volume and a lower respiratory rate in ICU patients without moderate or severe ARDS.

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.

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 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.…

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…