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A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve (EBV)
Therapy vs. Standard of Care (SoC) in Heterogeneous Emphysema.

To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using the Pulmonx Zephyr Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subject in a controlled trial design setting.

Tidal ventilation distribution and patient-ventilator synchrony during Proportional Assist Ventilation with load-adjustable gain factors

To compare the tidal volume distribution and other ventilator parameters between PAV+ and NAVA.

TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral
Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic
Chemotherapy in Patients with Mutant EGFR Non-small Cell Lung Cancer
(NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase
Inhibitor (TKI) and Platinum-doublet Chemotherapy

Primary Objective• To compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the progression-free survival (PFS), with that of single-agent cytotoxic chemotherapy in patients with EGFR mutated,…

A multi-center, randomized open label study to assess the systemic exposure, efficacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC) (CLDK378A2112)

Primary: To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily with a low-fat meal as compared with that of 750 mg ceritinib taken daily in the fasted state in patients with metastatic ALK-positive NSCLC.Secondary: Overall response…

A randomized, double-blind, placebo-controlled study to compare the immune effects of multiple doses of vitamin D3 in patients with allergic rhinitis/rhino-conjunctivitis caused by birch pollen and in healthy control subjects.

The primary objective is to evaluate whether 2.5 µg VD3 analogue (Zemplar® * Abbvie) in multiple subcutaneously administered doses induces a more favourable (read: anti-inflammatory) systemic immune modulation both in general parameters and allergen…

A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF)

The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…

A 26-week, randomized, double blind, parallel-group multicenter study to assess the efficacy and safety of QVA149 (110/50 mcg o.d.) vs tiotropium (18 mcg o.d.) + salmeterol/fluticasone propionate FDC (50/500 mcg b.i.d.) in patients with moderate to severe COPD

The purpose of this study is to determine whether the efficacy and safetyof QVA149 (110/50 *g o.d.) and triple treatment with tiotropium (18 *go.d.) + salmeterol/fluticasone propionate FDC (50/500 *g b.i.d.) arecomparable in patients with moderate…

A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib and subjects not on other treatment for IPF.

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…

The efficacy of the walk-bike on quality of life and exercise capacity in patients with idiopathic pulmonary fibrosis: a pilot study.

Primary objective• To assess the effect of use of a walk-bike in IPF patients for 8 weeks on health-related quality of life, measured with the St. George Respiratory Questionnaire, at baseline, week 9 and week 18, in patients with IPF.Secondary…

Lung Volume Reduction Coil for Treatment in Patients with Emphysema (RENEW) Study

The primary objective of this study is to determine whether treatment with the RePneu LVRC System results in improved exercise capacity and quality of life, as measured by improvements in the 6 Minute Walk Test (6MWT).

An open-label, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care +/- continuous bevacizumab treatment beyond progression of disease (PD) in patients with advanced non-squamous non-small cell lung cancer (NSCLC) after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy

The main aim of this study is to find out if the continuation of bevacizumab, in addition to standard 2nd & 3rd -line treatment, can help patients with NSCLC that has progressed to live longer. The study also aims to find out if continued…

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 Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension

The primary objective of this study is to:Evaluate the effect of GS-4997 on pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in subjects with pulmonary arterial hypertension (PAH).

Patterns and processes of cognitive and behavioural changes in patients with COPD receiving smoking reduction treatment - The REDUQ II study

The REDUQ II study will be conducted to help us to complete data on the secondary endpoints of the REDUQ study (P09-22) and arrange and examine relationships occurring between and among intervention elements of the REDUQ study, behavioural and…

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, parallel group PhIII study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps (study 205687, SYNAPSE)

Primary:To evaluate the efficacy of 100mg mepolizumab compared to placebo.Secondary:The impact on actual nasal surgery. Further efficacy assessment. Quality of life.

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…

Diaphragm-protective mechanical ventilation in critically ill patients: A proof of concept study.

Primary objective of this study is to assess the feasibility of using a monitoring and a titration algorithm to prevent inactivity and excessive activity of the diaphragm. This will be determined by comparing the fraction of breaths where diaphragm…

Multi-centre, randomized, double-blind, parallel-group study evaluating the effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder once daily compared with Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in subjects with Chronic Obstructive Pulmonary Disease (COPD) (HZC102972)

Effect on bone mineral density.