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An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) That are Refractory to Treatment

Primary Objective To evaluate long term safety and tolerability of LAI (590 mg) administered once daily (QD) for up to 12 months in subjects who were refractory to standard multi-drug treatment and failed to convert in Study INS-212. Secondary…

Investigation of the applicability of dry powder inhalation in children with cystic fibrosis

The main objective is to determine whether children with CF are able to achieve an inhalation manoeuvre as required for aerosol generation and transport into the peripheral airways with the test inhaler. The secondary objectives are to determine…

Towards optimizing infliximab therapy in severe sarcoidosis patients: personalized medicine

To assess the percentage of patients with at least one subtherapeutic infliximab trough serum concentration, being < 1 mg/l.To assess the percentage of patients positive for AIAs at a minimum of one timepoint.To assess the percentage of…

Pharmacokinetic evaluation and tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis

The first objective to investigate is the pharmacokinetics of DP tobramycin using the Cyclops® at four different dosages. The other objective is the local tolerability of DP tobramycin using the Cyclops® at four different dosages.

Nebulising Amoxicillin-Clavulanic Acid in Patients with COPD (NACAP)

To investigate whether inhalation of nebulised amoxicillin clavulanic acid is effective in reaching amoxicillin sputum levels >= MIC 90 in patient with an exacerbation of COPD.

An open-label, two period study to determine the excretion balance and pharmacokinetics of 14C-GSK573719, administered as single dose of an oral solution and an intravenous infusion, to
healthy male adults

The purpose of the study is to investigate how quickly and to what extent GSK573719 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The compound to be administered will be labeled…

Pharmacokinetics of nasally administered tobramycin and colistin in Cystic Fibrosis

To investigate the clinical pharmacokinetics of tobramycin and/or colistin after nasal administration. With this pharmacokinetic parameters the safety of this treatment can be investigated.

Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of;Aztreonam 75 mg Powder and Solvent for Nebuliser;Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric;Patients with Cystic Fibrosis (CF) and New Onset Lower Respiratory;Tract Culture Positive for Pseudomonas aeruginosa (PA)

The purpose of this study is to evaluate whether aztreonam solution for inhalation (AZLI) is safe and effective for the treatment and complete eradication of a lung infection with PA (Pseudomonas aeruginosa) in patients with Cystic Fibrosis (CF) and…

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…

Investigation of the applicability of dry powder inhalation in school children

The primary objective is to determine from what age on children can operate a test inhaler correctly (handling). The secondary objectives are to determine whether children can generate a sufficiently large airflow and volume through the test inhaler…

External Strips during Recruitment Maneuver to Improve FRC in patients with ALI

This study is aimed to compare the changes of FRC after performance of three different placements of external stripes during recruitment maneuver

An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers

Primary:To compare total radioactivity (drug-related material) in plasma relative to parent plasma GW642444 concentration following a single oral dose (200µg) of [14C]-GW642444 in healthy male subjects.To determine the rate and extent of excretion…

A phase 1, 4-period, crossover, open-label study in healthy volunteers to assess the effect of different types of food on a single-dose of JNJ-64417184 administered as tablets.

The purpose of this study is to investigate how quickly and to what extent JNJ-64417184 is absorbed, distributed, metabolized and eliminated from the body. The pharmacokinetics of JNJ-64417184 when it is administered in the morning following the…

The effect of polyethylene glycol treatment on gut health in Cystic Fibrosis, a pilot study

Main objective: to assess the effects of PEG treatment on bile acid homeostasis in cystic fibrosis patients. Secondary objective: to assess the effects of PEG treatment on gastrointestinal symptoms and quality of life, and on gut health-related…

Physiological effect of the addition of CPAP on top of optimal oxygen supplementation on oxygenation and work of breathing in COVID-19 patients

The aim is to investigate how effective the addition of several PEEP levels provided by regular CPAP is in patients with COVID-19 with moderate oxygenation problems.

Neutrophil extracellular trap induced changes in (RSV-infected) pediatric human airway epithelial (HAE) cultures.

1) to determine NETs-induced changes in ex vivo (RSV-infected) pediatric HAE (e.g. mucus hypersecretion and cell death) and 2) to explore pharmacological inhibition of NETs in this context.

A Phase I-II study of virus neutralizing antibodies against SARS-CoV-2. A focus on convalescent plasma and hyperimmune anti-SARS-CoV2 immunoglobulines

Primary Objective:• To create a population pharmacokinetic model of SARS-COV-2 neutralizing antibodies as present in ConvP.• To create a population pharmacokinetic model of SARS-COV-2 neutralizing antibodies as present in Nanogam*plusSecondary…

COVID-19: ultra-Low Radiotherapy Dose1: Colorado-1 trial

To determine the pre-liminary efficacy of ultra-low dose radiotherapy for COVID-19 related pneumonia with respiratory insufficiency.

A Phase 1, Open-label, Randomized, 3-way Crossover Study to Assess the Pharmacokinetic
Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in
Healthy Subjects

The purpose of this study is to investigate how quickly and to what extent JNJ-64417184 and JNJ-53718678 are absorbed and eliminated from the body (this is called pharmacokinetics) when administered alone and when administered together. It will also…

Investigating the immune response to COVID-19 Vaccination in Lung Transplantation patients (COVALENT study)

To investigate the humoral and cellular immune response, and the development of immunological memory to the COVID-19 vaccination in lung transplantation patients. To clarify firstly if immunity develops in these patients and secondly, if the immune…