Active clinical trials for "Lung Diseases, Obstructive"

Management of complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted conception Dedicated Airway Stents for Central Airway Stenoses DASCAS Toulouse University Hospital is the sponsor of this research. This research will be conducted with the support of AnatomikModeling and ADERSPOT Background: Tracheobronchial stent are devices designed to manage central airway stenoses of various origins. Their shape and sizes are however not suitable for stenosis of complex anatomy. Purpose: The investigators propose to test the feasibility and safety of treating complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted conception Abstract: Central airway obstruction is currently managed with non-personalized stents, which are usually efficient but lead to severe and potentially lethal complications in 10% of cases (stent migration, obstructive granuloma, perforation, hemoptysis). These stents seem particularly unsuited for anatomically complex stenosis. Dedicated airway stents (wrought and tailored by 3D computer-assisted conception based on 3D chest CT-scan), by fitting perfectly tracheal or bronchial anatomy, should dramatically improve the tolerance and safety of such prostheses. This first feasibility study, dedicated to patients suffering from anatomically complex stenosis will test the safety of treating patients with these new approach. It should lead to larger studies evaluating these new types of stents in larger indications. After 3D computer-assisted modelization of airways, a virtual prosthesis and its shape are designed and the shape of the stent is wrought by 3D-machining by AnatomikModeling®. The stent is then build and sterilized by Sebbin® and inserted during rigid bronchoscopy on the same terms as pre-existing models. Close follow up is then conducted, including clinical evaluation after one week, three and six months; spirometry at one week and 6 months and chest CT-scan at one week.

This phase IIb randomized trial studies how well cholecalciferol (vitamin D3) supplementation works in strengthening inspiratory muscles in cholecalciferol-deficient patients with chronic obstructive pulmonary disease (COPD). Cholecalciferol supplementation may help reduce the risk of developing lung cancer and strengthen the diaphragm in cholecalciferol-deficient patients with COPD.

Study to assess the safety of two-week administration of 80 and 160 mcg of ipratropium bromide as delivered by the RESPIMAT® device and as determined by 24 hours ambulatory ECG monitoring in COPD patients. To assess the overall safety of the two doses of ipratropium bromide as delivered by the RESPIMAT® device when administered over a two-week period.

The aim of this multi-centre, double blind, randomised, controlled trial (DBRCT) is to assess the effect of low dose theophylline, singly and in combination with low dose oral prednisone, on COPD (Chronic Obstructive Pulmonary Disease) exacerbations, quality of life and secondary clinical outcomes compared with usual therapy and placebo over 48 weeks of treatment. 1670 symptomatic patients with COPD will be recruited in China for comparison of low dose theophylline versus placebo and low dose theophylline + low dose prednisone The primary end-point for this study is the annualised COPD exacerbation rate between the treatment groups. Secondary outcomes included time to first severe exacerbation requiring hospitalisation or death, health status, and pre- and post-bronchodilator spirometry.

The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

The study assessed the safety and ability of several doses of an orally inhaled medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared between the two nebulizer systems to determine what effect the device had on GIS delivery.

Purpose: to evaluate the immediate effect of automated oxygen titration compared to usual fixed-dose oxygen treatment during exercise in patients with COPD on long-term oxygen treatment. Methods: The study will be conducted as a double blinded randomized crossover trial with two arms. 40 ambulatory patients with COPD and home oxygen treatment will be included from AHH Hospital's catchment area. The patients will conduct two Endurance Shuttle Walk Tests (ESWT) in a crossover design using an O2matic device to deliver a variable oxygen dosage set at an SpO2-target of 90-94% and an O2-flow of 0 - 15 liters/min and using the patients´ usual fixed-dose oxygen delivery, in a randomized order. In both arms O2matic will monitor pulse rate and SpO2 continuously during the test, but only in the automated oxygen titration arm will O2matic adjust oxygen flow. The patient and the physiotherapist supervising the tests will be blinded to the oxygen dose. Primary outcome is the changes in perceived dyspnea intensity using Borg CR10 scale between walking with automated titration compared to fixed-dose treatment. Secondary outcomes are differences in walking time, the average oxygen consumption between automated oxygen titration and fixed-dose treatment and difference in time spent within acceptable SpO2-interval.

Chronic obstructive pulmonary disease (COPD) is characterized by dyspnea, as well as musculoskeletal and systemic manifestations. Photobiomodulation therapy (PBMT) with use of low-level laser therapy (LLLT) and/or light emitting diode therapy (LEDT) is an electrophysical intervention that has been found to minimize or delay muscle fatigue. The aim of this study is to evaluate the acute effect of PBMT with combined use of lasers diodes, light emitting diodes (LEDs), on muscle performance, exercise tolerance and metabolic variables during the 6-minute stepper test (6MST) in patients with COPD. Twenty-one patients with COPD will completed the 6MST protocol over 2 weeks, with 1 session per week. PBMT or placebo (PL) will be performed before each 6MST (17 sites on each lower limb, with a dose of 30 J per site, using a cluster of 12 diodes: 4 × 905 nm super-pulsed laser diodes, 4 × 875 nm infrared LEDs, and 4 × 640 nm red LEDs; Multi Radiance Medical™, Solon - OH, USA). Patients will be randomized into two groups before the test according to the treatment they will receive. Assessments will be performed before the start of each protocol. The primary outcomes are oxygen uptake and number of steps, and the secondary outcome are perceived exertion (dyspnea and fatigue in the lower limbs).

The purpose of this study is to evaluate the efficacy of Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder Inhaler in COPD

CHF6366 is a novel bifunctional compound displaying both muscarinic receptor antagonist and β2-adrenergic receptor agonist properties (MABA), with the potential to deliver optimal bronchodilation after inhalation dosing via two validated mechanisms in one molecule. The study will consist of three parts: Part 1 will consit of two cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF 6366 Part 2 will consist of four cohorts of asthmatic subjects to assess the saftey, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6366 Part 3 will consist of one cohort of COPD patients to asess safety, tolerability of a single dose of CHF6366 in an active and placebo controlled design