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The Dutch national inhaler care pathway for patients with asthma/COPD: a hybrid type III implementation study

The aim of this study is to identify barriers and facilitators for successful implementation of the care pathway, to ultimately inform national scale-up of the pathway.

The accuracy of unsupervised inspiratory capacity measurements performed by COPD patients

Primary ObjectiveTo assess the accuracy of inspiratory capacity measurements performed by COPD patients at rest in a unsupervised home setting compared to a supervised setting.Secondary objectives - To assess the accuracy of inspiratory capacity…

Evaluating transcutaneous electromyography of the respiratory muscles to identify patient * ventilator dyssynchrony in mechanically ventilated children * a feasibility study

The primary objective is to study the agreement between the peak-to-through EAdi-oes signal and the EAdi-tc signal. Secondary objectives include a) to study the sensitivity and specificity of the EAdi-tc signal to detect dyssynchronous breaths using…

An international, non-drug interventional, real-world cohort of PAH patients newly initiating PAH therapy with guideline-directed assessments of disease severity

Research QuestionThis study is designed to describe PAH patients in terms of their clinical characteristics, therapies used, disease progression, and outcomes (eg, death, hospitalization, risk category for predicted mortality risk [Boucly 2017;…

Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis

This study has been transitioned to CTIS with ID 2024-515964-30-00 check the CTIS register for the current data. • Allow patients to continue or start AP01 therapy for the treatment of ILD and IPF prior to regulatory approval or until the study is…

Fissure Closure with the AeriSeal System for CONVERTing Collateral
Ventilation Status in Patients with Severe Emphysema; A Multicenter, Prospective
Trial

The primary objective of this prospective study in subjects with severe emphysema is to evaluate the utility of the AeriSeal System to occludecollateral air channels in a target lung lobe with collateral ventilation (CV+) and convert the target lung…

A randomized, multi-center, open-label, cross-over study comparing critical errors, overall errors, training/teaching time, and preference attributes of the ELLIPTA dry powder inhaler versus the BREEZHALER dry powder inhalers, in adult participants with mild to moderate asthma.

Primary objective:To compare the proportion of participants who make at least one critical error after reading the section on inhaler use in the patient information leaflets (PILs) for ELLIPTA and BREEZHALER inhalersSecondary Objectives:To compare…

Comparison of a solid state versus balloon esophageal catheter for the estimation of pleural pressure in healthy subjects

To evaluate the accuracy of Pes under different levels of inspiratory loading and positions of the subject, measured with a solid state esophageal catheter compared to those Pes obtained by a standard balloon catheter.

A Double Blinded, Placebo Controlled, Crossover Infusion Study of Respiratory Pharmacodynamics of ENA-001 in Conjunction with Propofol, Hypoxia, and Hypercapnia

Primary Objectives:* To determine the safety and tolerability of ENA-001 in healthy subjects after low and high doses of ENA-001 under hypoxic and hypercapnic conditions in conjunction with low and high doses of propofol.* To determine the…

Harm reduction in anabolic androgenic steroid use

To investigate:- Whether a harm reduction strategy with education and counseling is effective in reducing the use of AAS by amateur athletes. - The harm reduction potential of an additional online consultation with a well-known fitness expert. -…

Assessing the diaphragm before and after Endobronchial Valve Treatment

To investigate the change in diaphragm function after bronchoscopic lung volume reduction treatment with endobronchial valves (EBV).

A Randomized, Double-Blind, Placebo-Controlled, 2-Way Crossover, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Danavorexton in Healthy Subjects Undergoing Opioid-Induced Respiratory Depression

Primary Objective:• To evaluate the safety and tolerability of danavorexton single IV infusion administered in healthy subjects undergoing OIRD.Secondary Objective:• To assess the PK of danavorexton single IV infusion administered in healthy…

An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer

The objectives and relevant endpoints of the study are as follows:Primary: To assess the safety and tolerability of ATL001 as amonotherapy and in combination with pembrolizumabSecondary: To evaluate the clinical efficacy of ATL001treatment as a…

Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema

The aim of this study is to 1) evaluate the safety and feasibility of lung volume reduction using LTDs and 1) evaluate the effectiveness

An exploratory study to assess the effect of benralizumab on small airway obstruction in patients with severe asthma using functional respiratory imaging

The primary objective of this study is to investigate the effect (and the onset of this effect) of benralizumab on specific image based airway volumes (SiVaw) and resistance (SiRaw) in subjects with severe eosinophilic asthma. Absolute change in…

COPD monitoring

The purposes of this feasibility study are: • to evaluate the correlation between COPD-related dyspnea and the EMG of respiratory muscles when simulating daily activities, to assess the dyspnea symptom in a more objective (measurable) way; • to…