983 results
Primary ObjectiveTo determine the influence of treatment for OSA opioid-induced respiratory depression (minute ventilation (Vi); tidal volume (Vt); respiratory rate (RR); end-tidal pCO2; SpO2).Secondary ObjectivesAim 2: To determine the influence of…
Primary Objective:To evaluate the efficacy and safety of 2 doses of benralizumab in patients with moderate to very severe Chronic Pulmonary Disease (COPD).Secondary Objectives:To evaluate the effect of two doses of benralizumab on:* health status/…
The REDUQ II study will be conducted to help us to complete data on the secondary endpoints of the REDUQ study (P09-22) and arrange and examine relationships occurring between and among intervention elements of the REDUQ study, behavioural and…
Analyse costs and effects of point of care (POC) C-reactive protein (CRP) measurement in children with non-severe lower respiratory tract infection (LRTI) in primary care.
Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).
OBJECTIVESThe objective is to quantify the cost-effectiveness and efficacy of formally applying the guideline evaluating the risk-benefit ratio of the duration of anticoagulant therapy (VKA treatment) by a previously developed VTE recurrence…
The primary objective of this study is to:Evaluate the effect of GS-4997 on pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in subjects with pulmonary arterial hypertension (PAH).
The Sport-2-Stay-Fit (S2SF) Study will investigate if an after school sports program increase the sustainability of a standardized interval training program in children and adolescents with a physical disability or chronic disease.
Primary objectives To demonstrate the non-inferiority of CHF 5993 pMDI versus fixed combination of fluticasone furoate/vilanterol plus tiotropium in terms of quality of life (change from baseline in the St. George*s Respiratory Questionnaire [SGRQ]…
Primary objective:To compare the change in small airways obstruction (FEF75%) in patients with CF when inhaling one ampule of inhaled tobramycin with the Akita® compared to standard of treatment (twice daily nebulization of one ampule using standard…
* To assess the safety and tolerability of inhaled PA101 delivered via eFlow in patients with IPF with refractory chronic cough.* To assess the efficacy potential of inhaled PA101 by measuring the changes in cough severity and the urge-to-cough as…
The first objective is to evaluate the superiority of CHF 5259 pMDI (glycopyrrolate bromide) (50 µg total daily dose) versus placebo in terms of FEV1 AUC0-12h normalised by time on Day 42.Key Secondary objectiveTo evaluate the superiority of CHF…
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…
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…
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…
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…
Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
The main purpose of this study is to assess whether the study drug anetumab ravtansine is more effective than treatment with vinorelbine in patients with stage IV, mesothelin overexpressing malignant pleural mesothelioma. Efficacy will be measured…