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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 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…

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 phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 Î*g o.d. vs inhaled tiotropium 18 Î*g o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD

This study is designed to demonstrate non inferiority of 150 *g o.d. of indacaterol versus tiotropium 18 *g o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment.

A 48-WEEK, DOUBLE BLIND, RANDOMIZED, MULTINATIONAL, MULTICENTRE, 2-ARM PARALLEL GROUP, REFERENCE TREATMENT CONTROLLED CLINICAL TRIAL OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA pMDI (CHF 1535 FOSTER®) VERSUS FORMOTEROL IN PATIENTS WITH SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Primary Objective:To demonstrate that CHF 1535 twice daily is superior to Formoterol twice daily in terms of COPD exacerbations rate during 48 weeks of treatment and in terms of pulmonary function (change in pre-dose morning FEV1 from baseline to 12…

Effects Of extra-fine particle HFA-becLomethasone (HFA-QVAR) Versus course particle treatment In smokers and ex-smokers with Asthma

Objective: To perform a study comparing the efficacy of extra-fine particle HFA-QVAR 200 µg b.i.d. to an equipotent dose of course particle HFA-beclomethasone (HFA-Clenil) 400 µg b.i.d. and with coarse particle HFA-fluticasone (GSK) 250 µg in ex-…

A randomized, double-blind, controlled, parallel group, 12-week treatment study to compare the efficacy and safety of the combination of indacaterol 150 µg once daily with open label tiotropium 18 µg once daily versus open label tiotropium 18 µg once daily in patients with moderate-to-severe chronic obstructive pulmonary disease.

To demonstrate the superiority of indacaterol 150 µg o.d. in combination with tiotropium 18 µg o.d. versus tiotropium 18 µg o.d. with respect to standardized area under the curve (AUC) for forced expiratory volume in 1 second (FEV1) between 5 min *…

A phase III multicenter, randomized, parallel, controlled, double blind study to investigate the safety and efficacy of inhaled mannitol over 12 months in the treatment of bronchiectasis.

2.1.1 Primary Objective:To evaluate the difference in the rates of graded pulmonary exacerbations in patients with bronchiectasis treated with inhaled mannitol compared with placebo control2.1.2 Secondary Objectives:EfficacyTo evaluate the…

A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multicentre Study to assess efficacy and safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and Fluticasone Propionate FP)/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.

Primary: Efficacy of FF/GW642444 100/25 mcg once daily in comparison with that of FP/salmeterol 250/50 mcg twice daily during 24 weeks.Secundary: Safety and tolerability.

A MULTINATIONAL, MULTICENTRE, RANDOMISED, OPEN-LABEL, ACTIVE-CONTROLLED, 26-WEEK, 2-ARM, PARALLEL GROUP STUDY TO EVALUATE THE NON-INFERIORITY OF FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE ADMINISTERED VIA PMDI (CHF 5993) VERSUS FIXED COMBINATION OF FLUTICASONE FUROATE PLUS VILANTEROL ADMINISTERED VIA DPI (RELVAR*) PLUS TIOTROPIUM BROMIDE (SPIRIVA®) FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY 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]…

A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma (study 205715)

Primary:To evaluate the effects of FF/UMEC/VI on lung function compared with FF/VI after 24 weeks of treatmentSecondary:To assess the efficacy (exacerbations), FEV1 3h post dose, asthma symptoms, safety and tolerability.

A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI) Relative to Budesonide and Formoterol Fumarate MDI and Symbicort® Pressurized MDI in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS)

To evaluate the effect of triple-therapy wih Budesonide, Glycopyrronium and Formoterol Fumarate (PT010) versus dual therapy with Budesonide and Formoterol Fumarate on asthma exacerbations in adult and adolescent subjects with inadequately controlled…

A 52-week, randomised, double-blind, double-dummy, parallel group,multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 (depemokimab) compared with mepolizumab or benralizumab

This study has been transitioned to CTIS with ID 2023-510230-84-00 check the CTIS register for the current data. To evaluate the efficacy of GSK3511294 100 mg (SC) every 26 weeks versus maintaining existing treatment with either mepolizumabor…