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A randomized, parallel group study to evaluate the effect of Umeclidinium (UMEC) added to Inhaled corticosteroid/ long-acting beta-agonist combination therapy in subjects with Chronic Obstructive Pulmonary Disease COPD (study 201314)

Primary: efficacy and safety of the addition of UMEC 62.5mcg once daily to ICS/LABA therapy, compared with placebo over 12 weeks in subjects with COPD.Secondary: effect of the addition of UMEC to ICS/LABA therapy on COPD-related health status…

A clinical study to evaluate the safety, tolerability, and pharmacokinetics of the MMP 12 inhibitor FP- 025 after multiple oral ascending dose administration, and to evaluate the effect of food after a single oral dose administration in healthy subjects

Primary* To determine the safety and tolerability of multiple oral ascending doses of FP 025 in healthy subjects.Secondary* To determine the pharmacokinetics (PK) of FP 025 after multiple oral ascending doses of FP 025 in healthy subjects.* To…

A randomised, double-blind (sponsor unblinded), placebocontrolled, parallel-group, multicentre study to evaluate the efficacy and safety of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease (PII116678)

Primary: To evaluate the effect of once daily repeat inhaled doses of GSK2269557 on lung parameters derived from HRCT scans in subjects with acute exacerbation of COPD,compared to placebo. Secondary: Other lung parameters derived from high…

Study 117113: Mepolizumab vs. Placebo as add-on treatment for frequently exacerbating COPD patients characterized by eosinophil level

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…

A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)

The objective of the trial is to confirm efficacy and a favorable benefit-risk ratio for BIBF 1120 in the treatment of IPF at the dose of 150 mg bid compared to placebo.

Effect of roflumilast on exacerbation rate in patients with COPD treated with fixed combinations of LABA and ICS. A 52-week, randomised double-blind trial with roflumilast 500 µg versus placebo.

* To investigate the effect of roflumilast 500 µg tablets once daily versus placebo on exacerbation rate, and pulmonary function and major adverse cardiovascular events (MACE) in COPD patients who are concomitantly treated with a fixed combination…

An explorarory, 12 week, randomised, partially double-blinded, placebo-controlled parallel group trial to explore the effects of once daily treatments of orally inhaled tiotropium + olodaterol fixed dose combination or tiotropium (both delivered by Respimat® inhaler), supervised exercise training and behavior modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD)

The primary objective is to confirm that bronchodilator monotherapy (tiotropium) plus behavioural modification, bronchodilator combination therapy (tiotropium + olodaterol FDC) plus behavioural modification, and bronchodilator combination therapy (…

A randomized, double-blind, placebo-controlled intervention study to assess the therapeutic effect of an extensively hydrolyzed infant formula with an added synbiotic mixture in infants with atopic dermatitis.

2.1 Primary study objectiveThe primary objective of this study is to investigate the therapeutic effect of an extensively hydrolyzed protein based infant formula with a synbiotic mixture on the severity of atopic dermatitis in infants.2.2 Secondary…

A randomized, double blind, placebo controlled, multi-centre study to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in chronic obstructive pulmonary disease patients with cachexia (CBYM338X2204)

Primary: Assess the effect of i.v. infusions of BYM338 on muscle volume of the thigh (assessed by MRI) at 4, 8, 16 and 24 weeks, compared to placebo, in COPD patients with pulmonary cachexia.Secondary: Effect on 6-minute walk test, safety and…

Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin versus Placebo in Burn Patients with Inhalation Trauma

The aim of this project is to address whether nebulized heparin:1) increases the number of ventilator*free days during 28*days in burn patients with inhalation trauma2) improves lung injury scores in burn patients with inhalation trauma3) reduces…

A randomized, double-blind, parallel group, 52-week study evaluating the efficacy, safety and tolerability of NVA237 in patients with poorly controlled asthma (CNVA237B2301)

Primary: To demonstrate the superiority of NVA237 50 *g o.d. compared to placebo in addition to background therapy with long acting B2 agonist/ inhaled corticosteroid (* 800 *g/day of budesonide or equivalent) in terms of trough FEV1 after 26 weeks…

A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease (DB2113361)

The primary objective of this study is to evaluate efficacy and safety. Secondary objectives: PK, PK-PD.

A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects with COPD.

The primary objective of this study is to evaluate the dose response, dose interval, efficacy, and safety of GSK961081 by studying three QD doses and three BID doses in subjects with COPD. The study will also evaluate the population PK, systemic PK-…

The role of corticosteroids on coagulation and inflammation in asthma

Primary objective:- To evaluate the effects of a 10 day-course of prednisolon on coagulation and fibrinolysis parameters in patients with mild-moderate astma, patients with severe asthma, and healthy controls.Secondary objectives:- To compare the…

A 26-week treatment multi-center, randomized, doubleblind, parallel-group, placebo and active controlled (open label) study to assess the efficacy, safety and tolerability of QVA149 (110/50 Î*g q.d.) in patients with moderate to severe chronic obstructive pulmonary disease (COPD)

Primary objective: To demonstrate the superiority of QVA 110/50 µg compared to both QAB149 150 µg and NVA237 50 µg in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose) following 26 weeks of treatment in patients with moderate to…

Positional therapy in patients with positional Obstructive Sleep Apnea Syndrome: A randomized controlled trial

Primary objective: To assess the efficacy of reducing the sleep time in supine posture with positional therapy using the position training device compared to the sleep position band in patients with mild and moderate positional OSAS.Secondary…

EVALUATION OF THE EFFICACY AND SAFETY OF 6 REPEATED DAILY
DOSES OF NEBULISED RPL554 0.018 mg/kg (6X)
IN ALLERGIC ASTHMATICS

To investigate the efficacy of repeated daily doses of nebulised RPL554 (0.018 mg/kg) by assessing the effect on FEV1 at day 1, 3 and 6 after daily inhaled doses of nebulised RPL554 0.018 mg/kg (6X) in 16 allergic asthmatics.

A 26-week treatment, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructive pulmonary disease (CNVA237A2304)

Primary objectivesTo confirm that NVA237 50µg o.d. (delivered via a SDDPI) vs. placebo significantly increases trough FEV1 (defined as mean evaluation at 23 h 15 min and 23 h 45 min post dose) following 12 weeks of treatment in patients with…

A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids (FFA115285)

Efficacy and safety during 24 treatment weeks.

A Two-Part, Double Blinded, Placebo Controlled, Crossover Repeated Stepped Infusion Dose Study of Respiratory Pharmacodynamics of GAL- 021 and Opioids (Protocol - GAL-021-104).

PrimaryPart 1: - To determine the respiratory response of low and high doses of GAL-021 in conjunction with a low dose of opioids and hypercapnia in healthy subjects. Part 2: - To determine the respiratory response of low and high doses of GAL-021…