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A novel class of regulators: the potential of IL-10 producing B cells in decreasing allergic inflammation in asthmatic patients.

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…

201956: A Long-term Access Programme for Subjects with Severe Asthma who Participated in a GSK-sponsored Mepolizumab Clinical Study

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…

A Dose-Finding and Longitudinal Biomarker Study of Rhinovirus Challenge in Healthy
Volunteers and Mild-Moderate Asthmatics to Evaluate the Safety and Use of a Human
Rhinovirus Preparation in Developing High Dimensionality Phenotypes (*Handprints*) for
Asthma

The overarching goal is to qualify a virus challenge model for use in basic research and clinical development. This model will provide a consistent approach to generating and testing hypotheses relating to virally induced asthma exacerbations, and…

*What children want and what they do: a real life study of the consistency and sustainability of the inhalation technique monitored with homemade video clips*.

Main objective: To investigate Differences in sustainability of inhalation technique of Diskus® and Autohaler® in the home situation. This will be measured with the inhalation checklist for the Diskus® and Autohaler®. Secondary objectives: * To…

A two part, double blind, placebo controlled, study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of multiple doses of QBM076 in patients with COPD

Primary Obejective:To evaluate the preliminary efficacy of 8 consecutive weeks of QBM076 in current or ex-smoking patients with stable COPD with spirometry grades I-III (according to the current GOLD strategy (GOLD 2013).Secondary Objectives:To…

A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to moderate asthma

Primairy Objective: To demonstrate therapeutic equivalence between Bricanyl Turbuhaler M3 and Bricanyl Turbuhaler M2 using bronchoprotective effect as outcome measure. Secondary Objective: To compare safety of Bricanyl Turbuhaler M2 and Bricanyl…

Treatment of chronic Respiratory failure in COPD patients with non-invasive ventilation: starting at home and selecting the right patient

Primary Objective: The aim of the present study is to investigate whether home initiation of chronic NIV in stable COPD patients with CHRF is non-inferior to inpatient initiation Secondary Objective(s): The secondary objective of the study is to…

A multi-centre, open label, single arm, 32-week treatment study in subjects with severe eosinophilic asthma not optimally controlled with current omalizumab treatment who are switched from omalizumab to mepolizumab 100mg subcutaneous (study number 204471- the OSMO study)

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…

The effects of dietary nitrate supplementation on metabolic efficiency in patients with COPD

To assess whether ingestion of dietary nitrate in the form of NaNO3 solution is able to improve metabolic efficiency and exercise training compared to a NaCl solution placebo. A secondary objective will be to gain more insight in potential…

STATIC IV: Efficacy of a loading dose of intravenous salbutamol in patients admitted to a PICU for severe acute asthma

To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the…

Study 201312: A Multi-Centre, Open-Label, Study of Mepolizumab in a Subset of Subjects with a History of Life Threatening/Seriously Debilitating Asthma Who Participated in the MEA115661 Trial

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.

An open label, randomized, single inhaled dose, three-way cross over pilot study to compare the pharmacokinetic profiles of different dry powder inhalers with tiotropium bromide in healthy volunteers.

Primary objective:* To compare the bioavailability of different dry powder formulations of tiotropium bromide in healthy volunteersSecondary objectives:* To compare the safety and tolerability of different dry powder formulations of tiotropium…

A randomized, double-blind, repeat dose cross-over study
to assess the bronchodilator effects of once daily QVM149
following morning or evening dosing for 14 days compared
to placebo in patients with asthma

To investigate the potential influence of time of dosing (morning or evening)on the bronchodilator effect of once daily orally inhaled QVM149 compared toplacebo.

A randomised, double-blind, placebo-controlled, parallel-group, multi-centre 24-week study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe
eosinophilic asthma on markers of asthma control (study 200862, MUSCA)

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…

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid Use in Adults and Adolescents with Oral Corticosteroids dependent Asthma (TROPOS)

Primary objective:• To evaluate the effect of tralokinumab compared to placebo in reducing the prescribed, OCS maintenance dose in adult and adolescent subjects with asthma requiring chronic treatment with maintenance OCS in addition to ICS/LABA.…

A randomized, double-blind, double-dummy, parallel group, multicenter study of once daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, twice daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and twice daily Fluticasone Propionate 250 mcg Inhalation Powder in the treatment of persistent asthma in adults and adolescents already adequately controlled on twice-daily inhaled corticosteroid and long-acting beta2 agonist (study 201378)

Primary: To demonstrate non-inferiority of RELVAR 100/25 once-daily to SERETIDE 250/50 twice-daily in adult and adolescent subjects 12 years of age and older with persistent asthma,adequately controlled on twice-daily ICS/LABA. Secondary: Adverse…

Efficacy of Single inhaler Maintenance And Reliever Therapy (SMART) with Spiromax® budesonide/formoterol versus fixed dose treatment with Diskus® fluticasone/salmeterol in COPD

This research proposal aims to investigate the efficacy of the SMART approach with budesonide/fomoterol versus fixed dose treatment with fluticasone/salmeterol in patients with COPD.

Activities of daily life (ADLs) before and after rehabilitation in patients with COPD.

To study the effects of pulmonary rehabilitation on daily physical activity in patients with COPD. It seems reasonable to hypothesize that an improved sub-maximal performance capacity following pulmonary rehabilitation and the correct use of ECTs…

The pharmacokinetics of intravenous salbutamol in pediatric status asthmaticus: a pilot study.

The primary objective is to explore the pharmacokinetic parameters of intravenous salbutamol in pediatric patients admitted to the intensive care unit. Secondary objectives are to explore a possible relationship between dose, plasma levels,…

A randomised controlled trial of Dabigatran Etexilate on airway inflammation and coagulation in severe corticosteroid dependent asthma.

To investigate the effect of dabigatran etexilate on airway inflammation, hemostasis and asthma control in patients with severe asthma.