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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…

Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non-cystic fibrosis bronchiectasis.

Page 18 of the protocol (v1.0, 4-Nov-2013):The primary objectives of this study are:- To evaluate the efficacy of ciprofloxacin DPI administered BID intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study…

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…

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.

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.

HZA116863: A Randomized, Double-Blind, Parallel Group, Multicenter Study of Fluticasone Furoate/Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, and Fluticasone Furoate 100 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents (HZA116863)

Primary: to compare the efficacy and safety of once daily (evening) administration of FF/VI 100/25 with FF 100 in adult and adolescent subjects >= 12 years of age with moderate to severe, persistent bronchial asthma over 12 weeks.Secondary:…

A RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY AND TOLERABILITY OF TWICE-DAILY ACLIDINIUM BROMIDE /FORMOTEROL FUMARATE COMPARED WITH TWICE-DAILY SALMETEROL/FLUTICASONE PROPIONATE FOR 24-WEEKS TREATMENT IN SYMPTOMATIC PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Section 7 of the protocol:7. TRIAL OBJECTIVES AND PURPOSE* To assess the long term bronchodilator efficacy of Aclidinium bromide/Formoterol fumarate, administered twice a day, compared to Salmeterol/Fluticasone propionate (SeretideTM AccuhalerTM) in…

Low dose dexamethasone in newly diagnosed sarcoidosis

The main objective of this intervention study is to assess the effects of low-dose dexamethasone therapy on the quality of life of newly diagnosed sarcoidosis patientsThe secondary objectives are to assess the effects of low-dose dexamethasone…

A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the
Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) with Eosinophilic Asthma.

The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic…

A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis

The primary objective of this Phase 3 extension study will be to obtain essential long term safety data to augment the overall safety database. The secondary objective will be to augment the efficacy information collected in the double-blind study (…

Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD, a randomized double-blind placebo-controlled trial

To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the previous year can decrease the exacerbation rate in the year of treatment.

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Cephalon Sponsored Study in Eosinophilic Asthma

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed. The secondary objectives of…

The predictive value of the acute effect of montelukast on an exercise challenge test for the outcome of longterm treatment with montelukast

What is the correlation between change in % fall in FEV1 (*FEV1) after an exercise challenge 20h after a single dose of montelukast and after 4 weeks of treatment with montelukast?

A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects with non-CF Bronchiectasis and Gram-Negative Endobronchial Infection

This study is designed to assess the safety and efficacy of aztreonam for inhalation solution/aztreonam 75 mg powder and solvent for nebuliser solution (AZLI) in subjects with non-CF bronchiectasis and gram-negative endobronchial infection.