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eVita COPD; Patient Centered Care through eHealth Solutions

The main aim is to investigate clinical effects of different implementation methods of online supported self-management for COPD patients in primary care. Secondary objectives include effects on well-being, health care use and actual use of the…

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…

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…

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…

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…

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 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.

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…

Efficacy of a physical activity coaching system for patients with COPD

Primary objective: To study physical activity of COPD patients before, during, and after pulmonary rehabilitation. To evaluate whether and to what extent our designed physical activity coaching system can support the maintainance of physical…

A double-blind, placebo-controlled, randomized, single and multiple ascending dose study (including food effect, pH effect, and Japanese bridging Study) of the safety, pharmacokinetics, and exploratory pharmacodynamics of oral BMS-986278 administration in healthy participants

The purpose of this study is to investigate how safe the new compound BMS-986278 is when it is administered as a single dose to healthy subjects. BMS-986278 has not been administered to humans before. It has been previously tested in the laboratory…

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Primary Objective:To evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) andivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and aminimal function mutation (F/MF subjects)Secondary…

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)

Primary Objective:To evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)Secondary Objectives:* To evaluate the…

A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of fevipiprant once daily plus standard-of-care (SoC) for assessment of the efficacy in reduction of nasal polyps size in patients with nasal polyposis and concomitant asthma

The purpose of this study is to evaluate the efficacy and safety of fevipiprant 150 mg and 450 mg compared to placebo in the reduction of nasal polyps size and the effect on symptoms, quality of life and smell via patient-reported outcomes in…

*Evaluating the effect of qualitative feedback on asthma control in adults with difficult to treat asthma by improving therapy adherence and inhalation technique*

The primary objective of this study is to improve asthma control in adults with difficult to treat asthma, by increasing therapy adherence and inhalation technique with qualitative feedback.

Respiratory muscle training in patients with Spinal Muscular Atrophy

The aim of this study is to assess the feasibility and efficacy of respiratory muscle training (RMT) in patients with SMA and respiratory muscle weakness.

A Phase 4, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of the effect of dupilumab on sleep disturbance in patients with uncontrolled persistent asthma

To assess the effect of dupilumab on sleep, to evaluate the effect of dupilumab on additional patient reported sleep outcomes, on objective sleep assessment, asthma symptoms, long function and the safety of dupilumab.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

Primary efficacy objectives:To evaluate the efficacy of lenabasum 20 mg twice per day (BID) compared to placebo in the treatment of cystic fibrosis (CF) by assessing the rate of pulmonary exacerbations (PEx) using primary definition of PEx.Secondary…

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…

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

Physiological-based cord clamping for infants with congenital diaphragmatic hernia: a multicentre randomised controlled trial

Primary Objective: To evaluate whether PBCC results in a reduced incidence of pulmonary hypertension in infants with CDH 24hrs after birth.Secondary Objectives: To measure and monitor physiological parameters during transition to provide information…