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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.

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…

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…

Treatment of Chronic Idiopathic Cough (CIC) and Chronic Cough in patients with Idiopathic Pulmonary Fibrosis (IPF) with PA101.

The objectives of the study are as follows:*1. To assess the effectiveness of inhaled PA101 delivered via eFlow high efficiency nebulizer for treating chronic cough. Improvements in chronic cough will be assessed by measuring the change from…

A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to moderate asthma

Primairy Objective: To demonstrate therapeutic equivalence between Bricanyl Turbuhaler M3 and Bricanyl Turbuhaler M2 using bronchoprotective effect as outcome measure. Secondary Objective: To compare safety of Bricanyl Turbuhaler M2 and Bricanyl…

The effects of dietary nitrate supplementation on metabolic efficiency in patients with COPD

To assess whether ingestion of dietary nitrate in the form of NaNO3 solution is able to improve metabolic efficiency and exercise training compared to a NaCl solution placebo. A secondary objective will be to gain more insight in potential…

An open label, randomized, single inhaled dose, three-way cross over pilot study to compare the pharmacokinetic profiles of different dry powder inhalers with tiotropium bromide in healthy volunteers.

Primary objective:* To compare the bioavailability of different dry powder formulations of tiotropium bromide in healthy volunteersSecondary objectives:* To compare the safety and tolerability of different dry powder formulations of tiotropium…

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.

Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK)

Primary objective: To determine the safety of once daily inhalation of the recommended daily dose of tobramycin with the Akita® and the PARI-LC® Plus nebulizer in patients with CF. Systemic absorption can be used as surrogate parameter for safety.…

Multicenter randomized 2x2 cross-over study for patient satisfaction and function of the ProTrach DualCare

In this research we want to determine whether patients prefer the ProTrach DualCare over other speaking valves, if it improves quality of life, compliance with HME use and lung function.

Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety

Primary objective: To investigate whether pharmacokinetics of the recommended dose of inhaled tobramycin, defined as serum tobramycin Area Under the Curve (AUC0-24hr), with the I-neb (75 mg) is equivalent to the PariLCPlus (300 mg) nebuliser in…

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…

A Multi-center, Prospective, Randomized, Controlled Single Arm Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema.

Primary objective:To evaluate pulmonary function (FEV1) at 3 months following placement of Zephyr endobronchial valves in subjects with homogeneous emphysema.Secondary objectives:Evaluation of quality of life, exercise capacity, dyspnea incl. BODE,…

Hypertonic saline in primary ciliary dyskinesia: a pilot study

We hypothesize that hypertonic saline nebulizations improve respiratory symptoms and quality of life in PCD patients.

Evaluation of Pharmacokinetics, Relative Bioavailability, and Safety of PA-101 in Healthy Subjects, Patients with Systemic Mastocytosis, and Patients with Allergic Asthma

To evaluate the plasma pharmacokinetic properties and safety of the research medication in healthy volunteers and in Patients with Systemic Mastocytosis and Allergic Asthma.

A randomised, double-blind, placebo-controlled, cross-over study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending oral doses of GSK2239633 in healthy male subjects.

Primary:*To assess the safety and tolerability of single ascending oral doses of GSK2239633 in healthy male subjects. Secondary*To assess the pharmacokinetics of GSK2239633 following single ascending oral doses in healthy male subjects. * To assess…

Cognitive and emotional effects of sleep apnea and its rehabilitation in stroke patients

In this study the effect of SAS and the treatment with CPAP on cognitive functioning, fatigue and mood in stroke patients will be investigated. The main research questions are: 1) Is there a relationship between (the severity of) SAS and cognitive…

Alternative APAP Method for Non-invasive Positive Airway Pressure Therapy in OSAHS patients.
Amendment: Mallampati score as a predictor for effective Positive Airway Pressure

1. To investigate whether an adjusted mode of APAP can improve patients adherence in comparison to fixed CPAP in present-day PAP therapy of OSAHS patients.2. To investigate the agreement between the parameters of the CPAP devices and the polygraphy…

The role of diaphragm muscle EMG monitoring on respiratory physiology in mechanically ventilated patients with ARDS: a pilot study

The objective of this pilot study is to demonstrate that NAVA ventilation is superior compared to pressure support and pressure control ventilation in work of breathing (expressed as pressure-time product) patient ventilator synchrony and other…

Study evaluating ease of use, preference and satisfaction of two different Fluticason/salmeterol inhalers in asthma or COPD patients

To assess the percentage of COPD and asthma patients correctly (all critical items correct) using the Accuhaler/Diskus vs Elpenhaler inhaler devices after reading the package insert. Also satisfaction with and preference for an inhaler will be…