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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…

Assessment of real life and trained inhalation of Tobramycin Inhalation Powder (TIP) and Tobramycin Inhalation Solution (TIS) TIPTIS study.

Primary objective of the study is to record TIP inhalations on video at home to study the association between inhalation manoeuver and cough. Secondary objectives are: To study the inhalation maneuvers of patients using TIP in the home situation; to…

A Microdose Study to Describe the Intravenous Pharmacokinetics of [14C]-GSK2239633 in Healthy Male Subjects.

Primary:To investigate the intravenous pharmacokinetics of [14C]-GSK2239633 in healthy male subjectsTo compare total radioactivity (drug-related material) in plasma relative to parent plasma concentrationTo determine total radioactivity (drug-…

Mucoviscidosis and Inflammation, Variability through Exercise and Training: physical exercise program

Primary objective:What is the effect of a 12 weeks physical exercise program on the exercise induced inflammatory response in patients with cystic fibrosis?Secundary objectives:- What are the differences in pre-training basal immune values 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…

Health effects of sport participation in children and adolescents with a chronic disease or condition.
Sport-2-Stay-Fit (S2SF) study

The Sport-2-Stay-Fit (S2SF) Study will investigate if an after school sports program increase the sustainability of a standardized interval training program in children and adolescents with a physical disability or chronic disease.

Multi-center, randomized, double-blind, placebo-controlled phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508
homozygous Cystic Fibrosis patients

The aim of this trial is to test in a first clinical study the above mentioned hypothesis that BAY63-2521 can at least partially correct deltaF508-CFTR function. Therefore, we plan to include patients with Cystic Fibrosis, who are homozygous for the…

Are children with congenital heart or lung disease fit-to-fly?

This study will investigate the feasibility of a hypoxic challaenge test (60 minutes duration). During this test the inspired air will have a oxygen content of 15%. This is a comparable value as is used during a commercial airline flight (ca 2500…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate
the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

To evaluate the efficacy of VX-661 in combination with ivacaftor through 24 weeks of treatment in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis

A clinical research study to find out if Xolair is safe and has beneficial effects in adolescents (12 years old and above) and adults with cystic fibrosis (CF) and ABPA. All patients entering the study will be taking oral corticosteroids (steroid…

Mucoviscidosis and Inflammation, Variability through Exercise and Training: Maximal exercise test

Primary objective: *What is the effect of an incremental maximal exercise test on inflammation in patients with cystic fibrosis and in healthy people?*Secundary objectives:- What are the differences in basal immune values between HP and CF patients…

Evaluating lung deposition and pharmacokinetics after controlled inhalation of a radiotracer containing tobramycin aerosol in patients with Cystic Fibrosis

The study the influence of two different inhalationflow manoeuvres on the lungdeposition in patients with cystic fibrosis categorized to patientgroups varying in FEV1 longfunction value and age.

A phase II/III, randomised, double-blind, placebo-controlled, parallel group trial to evaluate safety and efficacy of tiotropium inhalation solution (2.5 µg and 5 µg) administered once daily in the afternoon via Respimat® Inhaler for 12 weeks in patients 1 to 5 years old with persistent asthma

The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of…

The effect of curcumin and genistein in CF patients with a class III mutation

Primary objective:To investigate the clinical response to treatment with curcumin and genistein in CF-patients with a class III S1251N mutation.. Secondary objectives:1.To evaluate the correlations between individual curcumin+genistein induced CFTR…

Cardiovascular system in Children with Cystic fibrosis

We hypothesised that cardiovascular changes already exist in children with cystic fibrosis compared with healthy control children. Therefore, we will evaluate the cardiovascular system in a group of children with cystic fibrosis compared with…

Assessment of Amnioninfusion for improving perinatal outcomes after midtrimester preterm prelabour rupture of membranes (PPROMEXIL III)

This study will answer the question if (repeated) abdominal amnioninfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will…

Inspiratory muscle training prior to peripheral muscle training in patients adolescents with Cystic Fibrosis.

1. Is a home-based peripheral muscle training program (5BX) more effective in (a) increasing peak work rate and (b) patients* preferred occupational performance in patients with CF who are preconditioned by IMT?2. Which variables are indicators of…

Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study

The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies with inhaled mannitol have demonstrated improvements in lung function, mucociliary…

A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Primary Objective:To evaluate the efficacy of ELX/TEZ/IVA in subjects 6 through 11 years of age with CF, heterozygous for F508del and a MF mutation (F/MF)Secondary Objectives:• To evaluate the PD of ELX/TEZ/IVA• To evaluate the safety of ELX/TEZ/IVA

A multicenter, randomized, 52-week, double-blind, parallelgroup, active controlled study to compare the efficacy and safety of QVM149 with QMF149 in patients with asthma

The purpose of the trial is to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 *g and QVM149 150/50/160 *g via Concept1) over two respective QMF149 doses (QMF149 150/160 *g and QMF149 150/320 *g via Concept1 in…