1240 results
Primary Safety Objective * Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602*2403 mg/d and nintedanib at a dose of 200*300 mg/d Secondary Safety Objective * Proportion of patients who discontinue…
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.
To evaluate image quality and accuracy of detection of perfusion defects associated with pulmonary pathology on iodine maps of the lung that are created by two different CT techniques: 1. A standard of care CTPA with DECT and 2. A new technique that…
Primary Objective To evaluate long term safety and tolerability of LAI (590 mg) administered once daily (QD) for up to 12 months in subjects who were refractory to standard multi-drug treatment and failed to convert in Study INS-212. Secondary…
To identify and define characteristics of healthy lymph nodes and lymph nodes involved in different pulmonal diseases (lungcancer and sarcoidosis)
In this study changes in blood acidity, oxygen tension in the blood, carbon dioxide tension in the blood, respiratory rate and tidal volume (reduction) in the first 24 hours after start of ECCO2R are registered and analyzed. Safety variables during…
To compare the tidal volume distribution and other ventilator parameters between PAV+ and NAVA.
Primary Objective• To compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the progression-free survival (PFS), with that of single-agent cytotoxic chemotherapy in patients with EGFR mutated,…
Primary: To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily with a low-fat meal as compared with that of 750 mg ceritinib taken daily in the fasted state in patients with metastatic ALK-positive NSCLC.Secondary: Overall response…
This study aims to investigate the feasability to use DW-MRI for mediastinal restaging after concomitant chemoradiotherapy and the feasabilitiy to predict whether or not mediastinal downstaging will be achieved during concomitant chemoradiotherapy…
The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…
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…
Primary objective: To evaluate whole body distribution of 89Zr-pembrolizumab in patients with locally advanced or metastatic melanoma or NSCLC. Secondary objectives: i) To evaluate pharmacokinetics of 89Zr-pembrolizumab; ii) To assess the…
To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib and subjects not on other treatment for IPF.
The purpose of this study is to determine the accuracy of the point-of-care IgE assay in atopic patients and healthy subjects. The POCT results will be compared to a reference immunoassay method for measuring this analyte.It intends to use this new…
1). To compare temporal fluctuations of lung function and inflammatory biomarkers in blood, nasal lavage, exhaled air and urine between patients with asthma and controls.2). To investigate the change in variations of these biomarkers upon…
Conditions that promote IL-10 producing B cells in humans are still ill defined. In this project our aim is to investigate the frequnecy of IL-10 producing B cells in healthy volunteers. Next, we aim to compare this to the frequency of IL-10…
The primary objective of the study is as follows:· To compare the rate of asthma exacerbations between patients with low baseline periostin levels (< 50 ng/mL) and patients with high baseline periostin levels (* 50 ng/mL), as measured by…
Objective:The aim of our study is to obtain a collection of head and neck squamous cell carcinomas that is well characterized for relevant clinical parameters, including follow-up.
The objective of this protocol is to provide a mechanism to supply mepolizumab on an individual subject basis to eligible asthma subjects who previously participated in a GSK-sponsored mepolizumab study. During the execution of the protocol SAEs…