Search for a trial

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…

A Randomized, Double-Masked, Sponsor-Unmasked, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRM-151 Administered Intravenously to Patients with Idiopathic Pulmonary Fibrosis

PRM-151 is being developed for potential therapeutic use to prevent, treat and reduce fibrosis. This study will provide an assessment of the safety, tolerability, pharmacokinetics and pharmacodynamics of PRM-151 after administration of ascending…

Reduction of asthma exacerbation rate in children by non-invasive monitoring of inflammatory markers in exhaled breath (condensate): the RASTER study

The purpose of the present proposal is to improve care to children with asthma by including regular assessments of non-invasive inflammatory markers during the management of asthma. In this case, treatment is also guided by inflammatory markers (…

GRACE (Genomics to combat Resistance against Antibiotics for Community acquired LRTI in Europe) INTRO (INternet TRaining for antibiOtic use) Trial

This study will compare antibiotic prescribing levels for practices trained via the GRACE INTRO programme (a self directed web based learning package combined with patient booklets), with those not trained, and in addition will determine whether the…

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…

A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray (FFNS) 110 mcg, administered either once daily or twice daily, compared with placebo, as effective monotherapy in the treatment of uncomplicated acute rhinosinusitis (ARS) in adult and adolescent subjects 12 years of age and older.

The objective of this study is to evaluate the safety and efficacy of two doses of FFNS (110 mcg once daily and 110 mcg twice daily) compared to placebo as monotherapy in the treatment of adult and adolescent subjects 12 years of age and older with…

A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

The primary objective is to demonstrate superiority in overall survival of amrubicin (40 mg/m2 administered as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course) compared with topotecan hydrochloride (…

The airway smooth muscle cell in asthma:
A genomics approach

To examine the difference in gene expression profiles of ASM in bronchial biopsy specimens between asthmatic patients, non-asthmatic allergic and non-asthmatic non-allergic controls.To associate the gene expression profiles with airway…

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.

A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 µg / 5 µg; 5 µg / 5 µg) (delivered by the RESPIMAT) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the RESPIMAT) in patients with Chronic Obstructive Pulmonary Disease (COPD) [TOnadoTM 1]

The objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium plus olodaterol fixed dose combination compared with the individual components tiotropium and olodaterol (delivered by…

Multicenter, double-blind, placebo-controlled, randomized, prospective study of bosentan as adjunctive therapy to inhaled nitric oxide in the management of persistent pulmonary hypertension of the newborn (PPHN)

To assess the efficacy of bosentan in neonates with persistent pulmonary hypertension of the newborn (PPHN) who are in need of continued inhaled nitric oxide (iNO) after at least 4 hours of continuous iNO treatment and to evaluate the…

Detection and treatment of endobronchial (pre-)malignant lesions after treatment of early stage lung cancer in COPD patients

PRIMARY OBJECTIVE1. To assess the effect of screening with AFB and subsequent treatment of endobronchial lesions in addition to screening with CT scan on cancer free survival of COPD patients previously treated for early stage NSCLC. SECONDARY…

Influence of hyperglycaemia and sustained hypoxia on the hypoxic ventilatory response and the hypoxic pulmonary vasoconstriction.

In this study we want to investigate the effects of sustained hyperglycaemia and hypoxia on the hypoxic pulmonary vasoconstriction and hypoxic ventilatory response

Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

BAY 63 2521 is a direct stimulator of the soluble Guanylate Cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially Pulmonary Hypertension (PH).To assess the efficacy and safety of oral BAY 63 2521 in the treatment of…

An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension

The primary objective of this study is to assess the comparative safety and efficacy ofAztreonam Lysine for Inhalation (AZLI) and Tobramycin Nebuliser Solution (TNS) in adultand pediatric cystic fibrosis (CF) patients aged 6 years or older with…

PEEP resuscitation in preterm neonates, a double blinded, randomized, controlled trial comparing 5cmH2O and 8cmH2O PEEP.

In this multicenter trial we compare resuscitation of preterm neonates with either 5 cm H2O PEEP or 8 cmH2O PEEP. We think resuscitation with 8 cmH2O PEEP results in a better outcome compared to resuscitation with 5 cmH2O PEEP.

A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension

Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 12) in subjects with PAH who are not currently receiving ERA, PDE-5…

CoCo in COPD treatment: evaluation of use, satisfaction and clinical effects

The primary objective of this study is to evaluate the CoCo application in the regular treatment of the MST and associated physiotherapy practices. We will investigate the use of the application, the application satisfaction, satisfaction of care…

Physical Exercise Training Programme COPD in Primary care

1) To assess the effectiveness of a physical exercise training programme in patients with mild to moderate COPD in the primary care setting, in comparison with usual care. 2) To analyse the main physiological (and behavioural) characteristics of…