26 results
To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using the Pulmonx Zephyr Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subject in a controlled trial design setting.
Primary* To determine the safety and tolerability of multiple oral ascending doses of FP 025 in healthy subjects.Secondary* To determine the pharmacokinetics (PK) of FP 025 after multiple oral ascending doses of FP 025 in healthy subjects.* To…
Primary objective:To evaluate pulmonary function (FEV1) at 3 months following placement of Zephyr endobronchial valves in subjects with homogeneous emphysema.Secondary objectives:Evaluation of quality of life, exercise capacity, dyspnea incl. BODE,…
The objective of this pilot study is to demonstrate that NAVA ventilation is superior compared to pressure support and pressure control ventilation in work of breathing (expressed as pressure-time product) patient ventilator synchrony and other…
To investigate both the clinical and economical(-healthcare evaluation) improvement of BVR using best responder criteria in patients with severe COPD.
PrimaryPart 1: - To determine the respiratory response of low and high doses of GAL-021 in conjunction with a low dose of opioids and hypercapnia in healthy subjects. Part 2: - To determine the respiratory response of low and high doses of GAL-021…
The purpose of this trial is: • to study the effect of a single dose of GAL-054 (the test medication) in healthy volunteers on the functioning of the body, especially on respiration, and compare this with the effect of a single dose of doxapram.• to…
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC (2.5/5 µg, 5/5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment.
Compare if once daily laba/lama treatment with two different dosages shows the same or better result on the 24 hr lungfunction than twice daily treatment of two different dosages with ICS/laba treatment. .
Compare the performance of the Philips Respironics Sleep Therapy Auto System to a fixed CPAP device for the treatment of OSA and validate its event detection capabilities.
D1. Comparing the made distance in meters within a fixed time between a walker and a walk-bike used by COPD patients.D2. Comparing the walking time and distance on an outdoor track between a walker and a walk-bike used by COPD patients.
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 / 5 µg ; 5 / 5 µg) with tiotropium (5 µg), olodaterol (5 µg) and placebo on lung-hyperinflation and endurance time…
Comparing the metabolic response (oxygenuptake and ventilation) and symptom perception (borgscores for dyspnoea and fatigue) between neuromuscular electrical stimulation with low-frequency and high-frequency.
Primary objectiveTo evaluate the relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on trough FEV1 after 28 days of treatment, as defined by the percentage of the maximal effect that each dose achieves in relation to the…
Tiotropium is available in the pharmacy as solution for inhalation (daily dose of 5 mcg) and as inhalation powder (daily dose of 18 mcg). The objective of the present study is to compare three doses of tiotropum solution for inhalation (daily dose…
To evaluate the potential attenuating effects of a one-week supplementation with 2 x 250 mg caffeine per day on blood biomarkers of systemic inflammation in COPD patients.
To study the possible relation between systemic inflammation and oxidative stress and muscle breakdown using pharmacological interventions.
The first objective is to evaluate the superiority of CHF 5259 pMDI (glycopyrrolate bromide) (50 µg total daily dose) versus placebo in terms of FEV1 AUC0-12h normalised by time on Day 42.Key Secondary objectiveTo evaluate the superiority of CHF…
The primary objective of the study is to evaluate the effect of tiotropium + olodaterol FDCcompared to tiotropium monotherapy on the intensity of breathlessness during the 3min CSST.A secondary objective is to explore the relationship between…
Primary objective: To evaluate the efficacy of targeted lung denervation (TLD) in addition to optimal medical care to reduce moderate or severe exacerbations and related hospitalizations, compared with optimal medical care alone, in subjects with…