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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…

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…

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 randomized, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 µg delivered by the HandiHaler®.

To compare the efficacy and safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 µg delivered by the HandiHaler®.

The effects of plant stanols on the immune function of asthma patients

The major research objective is to prove that the consumption of plant stanol ester enriched yogurts can improve immune function in vivo in asthma patients

A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 µg / 5 µg; 5 µg / 5 µg) (delivered by the RESPIMAT) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the RESPIMAT) in patients with Chronic Obstructive Pulmonary Disease (COPD) [TOnadoTM 1]

The objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium plus olodaterol fixed dose combination compared with the individual components tiotropium and olodaterol (delivered by…

The effect of nebulisation of ipratropiumbromide on oxygenation and end-expiratory lung volume in mechanically ventilated children: a pilot study

We hypothesize that nebulisation of ipratropiumbromide results in decreased production of sputum resulting in a better lung aeration (defined by an increase in EELV) and improved oxygenation (as defined by the PaO2/FiO2 ratio and the oxygenation…

A 64-week treatment, multi-center, randomized, double-blind, parallel-group, active controlled study to evaluate the effect of QVA149 (110/50 *g o.d.) vs NVA237 (50 *g o.d.) and open-label tiotropium (18 *g o.d.) on COPD exacerbations in patients with severe to very severe chronic obstructive pulmonary disease (COPD) (CQVA149A2304)

Primary objective: To demonstrate that QVA149 (110/50 *g o.d.) is superior to NVA237 (50 *g o.d.) with regard to the rate of moderate to severe COPD exacerbations during 64 weeks of treatmentSecondary objectives: To demonstrate that QVA149 (110/50 *…

The effectiveness of remote monitoring in improving CPAP compliance: a randomised, controlled study.

This study emphasizes on the effect of telemonitoring and the effect on compliance in the first period after starting the treatment.

A phase Ib/II, open-label, multicenter trial with oral cMET inhibitor INC280 alone and in combination with erlotinib versus platinum/pemetrexed in adult patients with EGFR mutated, cMET-amplified, locally advanced/metastatic non-small cell lung cancer (NSCLC) with acquired resistance to prior EGFR tyrosine kinase inhibitor (EGFR TKI)

Primary phase 1: To determine MTD and/or RP2D of INC280 incombination with erlotinibPrimary phase 2: To compare the antitumor activity of INC280 alone, and INC280 in combination with erlotinib, vs platinum with pemetrexed, as measured by Progression…

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…

Healt status guided COPD (March)

We hypothesize that a treatment algorithm that is based on a simple validated measure of health status (CCQ) improves quality of life (as measured on a separate scale) and other classical COPD outcome measurement parameters such as exacerbation…

Peripheral targeting of inhaled rhDNase in stable CF patients.

Primary Objective: To investigate the effect of treatment with nebulized rhDNase targeted to the peripheral airways compared to rhDNase targeted to the central airways on FEF75 in children with CF who are on maintenance treatment with rhDNase.…

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…

SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma.

The primary objective of the study is to evaluate whether the addition of LABA to ICS therapy (FSC) is non-inferior to ICS therapy alone (FP) in terms of the risk of serious asthma related events (asthma-related hospitalization, endotracheal…

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.

Optimizing COPD care in primary care: going for Silver or for Gold?

To evaluate a result oriented smoking cessation program in which treatment goals are signed up in a doctor-patient contract.

Effect of mechanical ventilation on plasma cytokine concentrations in healthy humans

Our primary goal is to compare the effects of a positive pressure mechanical ventilation with spontaneous breathing on systemic cytokine release in patients with normal pulmonary function. Secondly, the possible effects of surgery on the ventilation…

Randomized phase II study of amrubicin as single agent or in combination with cisplatin versus etoposide-cisplatin as first-line treatment in patients with extensive stage SCLC (ES).

Investigate the activity and safety of amrubicin alone versus amrubicin incombination with cisplatin versus standard treatment for extensive disease(ED) small-cell lung cancer in the first line setting.

Prevention of passive smoking exposure in children with a high risk on asthma: the results of a individualized, tailored intervention.

The current proposal aims at testing an innovative, implementable, effective intervention strategy towards stopping of passive smoke exposure in children at risk for asthma.