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A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subject with Cystic Fibrosis aged six to seventeen years.

The purpose of this trial is primarily to assess the efficacy of inhaled mannitol compared with a true placebo in subjects with cystic fibrosis aged 6 to 17 years.We hypothesize that inhaled mannitol will improve the overall health and hygiene of…

RITUXIMAB IN LIFE THREATENING THERAPY RESISTANT PROGRESSIVE INTERSTITIAL PNEUMONITIS

The main objective of this study is to assess the effects of rituximab (RTX) as a rescue therapy for therapy resistant progressive IMID- IP patients. Specifically there is an objective assessment of (1) pulmonary function tests (PFTs) and (2)…

A Phase II Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of VS 6063 in Subjects with Malignant Pleural Mesothelioma

Primary Efficacy Objectives• To compare the overall survival (OS) in subjects with malignant pleural mesothelioma receiving VS-6063 or placebo.• To compare the progression free survival (PFS) in subjects with malignant pleural mesothelioma receiving…

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…

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 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 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.

A randomized, open-label, active-controlled, Phase II study of intravenous anetumab ravtansine (BAY 94-9343) or vinorelbine in patients with advanced or metastatic malignant pleural mesothelioma overexpressing mesothelin and progressed on first line platinum/pemetrexed-based chemotherapy

The main purpose of this study is to assess whether the study drug anetumab ravtansine is more effective than treatment with vinorelbine in patients with stage IV, mesothelin overexpressing malignant pleural mesothelioma. Efficacy will be measured…

A Single Centered, Prospective, Open-labeled, Pharmacokinetic Pilot Study of Tacrolimus Administration via Rectiole

To determine the tacrolimus bioavailability after tacrolimus administration via a rectiole.

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.

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

The primary objective of this study is as follows:* To evaluate the effect of presatovir on RSV viral load in autologous or allogeneic HCT recipients with an acute RSV lower respiratory tract infection (LRTI)The secondary objectives of this study…

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…

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract

The co-primary objectives of this study are as follows:* To evaluate the effect of presatovir (GS-5806) on RSV viral load and development of lower respiratory tract complication (LRTC) in RSV positive autologous or allogeneic HCT recipients with…

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.

Handling oxygenation targets in adults with acute hypoxaemic respiratory failure in the intensive care unit: A randomised clinical trial of a lower versus a higher oxygenation target

To assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission.

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.

TIGER-2: A Phase 2, Open-Label, Multicenter, Safety and Efficacy Study of Oral CO 1686 as 2nd Line EGFR-Directed TKI in Patients with Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)

Primary Objective* To evaluate the antitumor efficacy of PO single agent CO-1686, as measured by ORR, when administered to patients with EGFR mutated, centrally confirmed T790M positive and T790M negative advanced NSCLC after tumor progression on 1…

A randomised open-label phase II trial of consolidation with nivolumab and ipilimumab in limited-stage SCLC after chemo-radiotherapy

The primary objective is to evaluate if patients treated with chemo-radiotherapy and prophylactic cranial irradiation followed by consolidation treatment (nivolumab plus ipilimumab) have a better outcome in terms of progression-free survival (time…