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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.…

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…

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.

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…

Treatment in patients with recurrent infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response.

The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…

An open label, part-randomised, four-way crossover, single and repeat dose study to determine the dose proportionality and absolute bioavailability of fluticasone furoate (FF) when administered as FF inhalation powder from the novel dry powder inhaler in healthy subjects.

The purpose of the study is to investigate to what extent blood concentrations of Fluticasone Furoate increase proportionately to rising doses of Fluticasone Furoate in three steps administered via a powder inhalator. In addition, the absolute…

An early diagnosis of asthma in young children by using non-invasive biomarkers of oxidative stress/airway inflammation, and early lung function measurements

This research proposal tests the hypothesis that an early asthma diagnosis is possible by using non-invasive biomarkers of oxidative stress/airway inflammation in exhaled air, venous blood and assessments of lung function (airway resistance by means…

A phase III, randomized, double-blind, double-dummy, placebo-controlled, multicenter, 3-period incomplete block, multidose crossover study to determine the effect on lung function of indacaterol (150 and 300 mcg o.d.) in patients with moderate to severe COPD, using tiotropium (18 mcg o.d.) as an active control

The study is designed to compare the 24-h spirometry profile of two doses of indacaterol (150o.d. and 300 *g o.d.) with that of placebo (o.d.) and with tiotropium (18 *g o.d.) as an activecontrol in patients with COPD.

A randomized, double-blind, placebo controlled, multicentre study to determine the effect of QVA149 on lungfunction in patients with Chronic Obstructive Pulmonary Disease (COPD).

The purpose of this study is to evaluate the effects of QVA149 300/50, a fixed dose combination of QAB149 300µg and NVA237 50µg, versus placebo and two doses of QAB149 300µg and 600µg, in terms of lung function in patients with moderate to severe…

Effect of Carbon Dioxide Enriched Ambient Air on Pharmacokinetics and Deposition In Bronchiectasis Patients Using Tobramycin Inhalation: A proof of concept study.

1. To asses (with planar imaging) whether SPECT/CT scan are feasible in assessing pulmonary deposition of inhaled tobramycin.2. To evaluate the effect of CO2 enriched ambient air on deposition of inhaled tobramycin in bronchiectasis patients.3. To…

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

Primary objective:To compare the change in small airways obstruction (FEF75%) in patients with CF when inhaling one ampule of inhaled tobramycin with the Akita® compared to standard of treatment (twice daily nebulization of one ampule using standard…

A phase 1, open-label, randomized, 2-way crossover study to assess the effects of acid reducing agent(s) on the pharmacokinetics of a single oral dose of JNJ-64417184 in healthy adult participants

The purpose of this study is to investigate how quickly and to what extent JNJ-64417184 is absorbed and eliminated from the body when it is given together with drugs that reduce the stomach acidity. The study also investigates how safe the new…

Study A: A placebo-controlled crossover study to assess safety of intranasal administration of palivizumab
Study B: Effect of intranasal administration of palivizumab on respiratory syncytial virus-associated infection - a double-blind randomized controlled trial

Study A: Safety of intranasal administration of palivizumab in healthy adultsStudy B: Effect of local administration of palivizumab on prevention of RSV infection