15 results
With this project we aim to determine the efficacy of anti-IL-5 treatment (mepolizumab) on virus-induced exacerbations in allergic asthma patients.Specific research questionsDoes IL-5 neutralisation:1) reduce the inflammatory response (T cell…
Primary: To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS).Secondary: Safety, tolerability, other efficacy parameters, quality of life.
To assess in women with a request for pain relief during labour the cost-effectiveness of remifentanil patient controlled analgesia (RPCA) as first choice compared to EA.
Primary: To collect long term safety data.Secondary: To collect data on long term asthma control.
Hypothesis to be tested (null hypothesis) : A continuous epidural infusion of bupivacaïne/sufentanil is equal to bupivacaïne/morphine in patients undergoing major surgery in terms of analgesia and side effects The aim of the study is to compare the…
Primary:To evaluate whether patients with severe eosinophilic asthma who have received longterm treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit.Secondary:To assess the safety…
Primary: To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) every 4 weeks versus placebo on health-related quality of life (HR-QoL) in adult and adolescent subjects with severe eosinophilic asthma. Secondary: To assess the effects of…
Primary:To evaluate the efficacy of 100mg mepolizumab compared to placebo.Secondary:The impact on actual nasal surgery. Further efficacy assessment. Quality of life.
Primary:To describe in a pragmatic setting whether there is an improvement in asthma control from the beginning to the end of the study,when directly switched to mepolizumab, in subjects with a severe eosinophilic asthma phenotype not optimally…
Primary:To assess the use of mepolizumab in safety syringe for the subcutaneous self-administration of mepolizumab by subjects with severe eosinophilic asthma.Secondary:To assess the use of mepolizumab in safety syringe outside the clinic setting.…
Primary: To provide extended treatment with mepolizumab to subjects with severe asthma and a history of improved disease control while receiving mepolizumab as defined by this protocol.Secondary: To collect data on long term clinical data.
Primary Objective:To compare the Cross Clamp Time collected with EDWARDS INTUITY Elite to published data with a conventional valve within a MIS approachSecondary Objectives:To describe short term (30 days) and long term (6 months) clinical safetyTo…
Objective: The objective of the study is establish the half-life of eosinophils in blood and sputum and determination of the effect of Nucala® hereon.
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 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…