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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.

Use of lung mechanics to identify the optimal level of positive end-expiratory pressure in mechanically ventilated children with acute lung injury: a pilot study

The primary objective is to study the level and time course of the end-expiratory lung volume during the individual incremental * decremental PEEP titration; the secondary objective is to study if there is a significant association between the end-…

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-…

The validity of performance tests, the 4 meter gait speed and the 5 repetitions sit to stand test, in patients suffering PF in daily clinical practice

Objective: The aim of this study is to assess the validity of the 4MGS and 5STS to determine the functional exercise performance of PF patients.

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.

Mesenchymal stem cells in emphysema: finding the right niche for alveolar repair

The projects is divided in 3 aims: 1) To evaluate the regenerative capacity of lung-derived MSCs (LMSCs) from normal and emphysematous lung tissue and compare LMCSs to MSCs derived from other tissues2) To investigate the interaction of MSCs with the…

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…

myAirCoach * The use of home-monitoring and mHealth systems to predict asthma control and the occurrence of asthma exacerbations

Therefore, the aim of the myAirCoach project is to develop and evaluate technologies that assist patients with asthma. To this purpose we developed a one year observational quantification campaign in which we will identify potentially relevant self-…

Bronchiolitis obliterans syndrome and other allo-reactive lung syndromes
after allogeinic hematopoietic stem cell transplantation
Is early prediction of bronchiolitis obliterans possible by using biomarkers possible?

In this study we would like to find new biomarkers in BOS after haematopoietic stem cell transplantation (HSCT), that may lead to earlier identification of BOS than a lung function decline.

Measuring work-of-breathing in mechanically ventilated children

The primary objective for this study is to compare the level and time course of the patient work-of-breathing during PS ventilation with the work-of-breathing during SIMV-PS ventilation with a lower rate of breaths per minute delivered by the…

Optimizing lung imaging in people with Ataxia Telangiectasia applying improved MRI techniques.

The purpose of this research project is to improve the overall quality and resolution of the MRI images, to correct for movement effects during the procedure and to speed up the investigation. The goal is to enhance and standardize a technique…

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 decision model for the management of acute exacerbation chronic obstructive pulmonary disease in the emergency department: flowchart for treatment allocation.

The primary objective is to validate a previously established prognostic instrument in the form of an algorithm (flowchart) in patients that present with AECOPD to the department of emergency medicine for classifying for out- or inpatient treatment…

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…