Active clinical trials for "Lung Diseases, Obstructive"

The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.

This is a comparative bioavailability study to compare the pharmacokinetics and pharmacodynamic effects of Fluticasone propionate and Salmeterol delivered in a capsule-based inhaler versus a multi-dose dry powder inhaler in patients with moderate asthma and in patients with moderate to severe Chronic obstructive pulmonary disease (COPD). Co-primary endpoints will be the area under the curve (AUCτ) measured for plasma Fluticasone propionate (pharmacokinetic) and the pharmacodynamic effects of Fluticasone propionate (weighted mean serum cortisol over 0-12h) on the last day of each 10 day study treatment period. Secondary endpoints will include the following pharmacokinetic parameters for both fluticasone propionate and salmeterol: AUClast, AUC(0-t), Cmax, Cmin, tmax, λz, and t1/2 as well as the pharmacodynamic effects of salmeterol (pulse rate, blood pressure, electrocardiogram [ECG], potassium and glucose) and Fluticasone propionate (urine cortisol levels). Safety (adverse events and laboratory abnormalities) will also be assessed as a secondary endpoint. The study is a randomised, double blind, double dummy, four-period cross-over study. Approximately 60 asthma or COPD patients will be randomised. Patients meeting eligibility criteria will receive Fluticasone propionate/salmeterol 250/50mcg bid, from a capsule-based inhaler and from a multi-dose dry powder inhaler for a period of 10 days each in a randomised order. All patients will receive treatment from each device twice. To maintain the double blind, each patient will receive active treatment and placebo at the same time from two separate devices.

COPD is a progressive disease characterized by increasing obstruction to airflow and the progressive development of respiratory symptoms including chronic cough, increased sputum production, dyspnea and wheezing. Once-daily triple therapy of an Inhaled Corticosteroid/ Long-acting Muscarinic Receptor Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) that is combination of FF/UMEC/VI in a single device is being developed with the aim of providing a new treatment option for the management of advanced COPD. The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/ UMEC/VI once daily via the ELLIPTA® dry powder inhaler (DPI) compared with tiotropium once daily via HANDIHALER®, in subjects with COPD. Subjects will be randomized 1:1 to receive FF/UMEC/VI or tiotropium in the morning for 84 days. Subjects will also receive albuterol/salbutamol as a rescue therapy throughout the study. Approximately 848 subjects with advanced COPD will be enrolled in the study. The total study duration will be approximately 17 weeks including, 4-week run-in period, 12-week treatment period and a 1-week follow-up period. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies. HANDIHALER and RESPIMAT are registered trademarks of Boeringher Ingelheim.

AZD8871 is a new chemical entity possessing long-acting effect in a single molecule which presents a novel treatment approach to chronic obstructive pulmonary disease [COPD] and potentially also asthma (in combination with an inhaled corticosteroid [ICS]). The therapeutic goal for AZD8871 is a treatment with greater efficacy than single mechanism bronchodilators, with an equivalent or superior safety and tolerability profile. The primary purpose of this study is to check the safety and tolerability of AZD8871 at steady state. A multiple ascending dose (MAD) design has been selected for this study following the first time in man (FTIM), single ascending dose (SAD) study. Three dose levels will be tested in an ascending manner. The first dose to be administered will be 300 μg and the 2 subsequent doses will be decided based on safety, tolerability and pharmacokinetic (PK) data generated in the previous dose. The aim of this study is to also enable further investigations in healthy subjects to evaluate and develop AZD8871 as a dual action bronchodilator with an acceptable side-effect profile compared to other inhaled bronchodilators on the market as a treatment for COPD and asthma.

Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease characterized by progressive airflow limitation that is associated with an inflammatory response to noxious particles or gases. Manual therapy (MT) has been defined as a therapeutic intervention that uses the hands to provide treatment to the musculoskeletal and/or visceral systems. It includes techniques such as massage, myofascial release, muscle energy technique, ligament balance, joint mobilization and joint manipulation. The suggestion that MT could deliver long-term benefits to people with COPD was first put forward in 2009. Since then a number of small studies have reported medium term improvements in lung function and exercise capacity following repeated applications of MT intervention. Our aim is to measure the immediate effect on lung function of a single application of soft tissue manual therapy in patients with severe and very-severe chronic obstructive pulmonary disease.

Taken recent literature together, there is a sufficient number of trials investigating the effect of different oxygen devices. However, studies comparing oxygen delivery via portable oxygen concentrator (POC) and liquid oxygen device (LOD) with appropriate exercise testing and sufficient power are missing. Given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of two different oxygen delivery systems during walking in hypoxemic COPD patients (POC vs. LOD). The endurance shuttle walk test (ESWT) is well validated for measuring endurance walking capacity in COPD patients with good repeatability. The advantage of this test over the 6MWT is that the ESWT is performed at 85% of the individual maximum which is close to the intensity of typical daily activities. Due to the fact that the ESWT enables us to determine the maximum duration of exercise and to compare values at isotime (at the point of time when the shortest of the 3 ESWTs ends), we use the ESWT as exercise test in our trial.

This is a prospective randomized controlled study to test the hypothesis that neuromuscular electrical stimulation (NMES) and remote pulmonary rehabilitation at home offered via a smart technology, called Smart TeleHealth, results in a reduction of systemic inflammation, via reduction of skeletal muscle tissue inflammation, and thereby improves functional capacity, and thus, reduces the rate of readmissions following hospitalization for acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). This study will enroll up to 40 participants at the University of Alabama at Birmingham (UAB), about 30 will get Smart Telehealth and NMES, and 10 will get usual care.

The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to inflammation in the lungs and blood vessels that can lead to secondary problems such as blood vessel disease, high blood pressure and heart disease. Aerobic exercise training has been shown to reduce the risk of heart and brain disease; however, it is currently unknown whether exercise training can have the same affect in patients with COPD. The aim of this study is to investigate how eight weeks of aerobic exercise training improves blood vessel and heart function and brain blood flow in patients with COPD.

The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/UMEC/VI [100/62.5/25 microgram (mcg)] once daily via the ELLIPTA™ compared with a multiple inhaler combination therapy of Symbicort Metered Dose Inhaler (MDI) (budesonide/formoterol 320/9 mcg) twice daily plus Spiriva HandiHaler (tiotropium 18 mcg) once daily. The study will inform healthcare providers that subjects can be effectively and safely switched to FF/UMEC/VI single inhaler therapy from a multiple inhaler triple therapy regimen of Symbicort MDI and Spiriva Handihaler. Eligible subjects will enter a 4-week run-in period during which they will be administered budesonide/formoterol (320/9 mcg) twice daily plus tiotropium (18 mcg) once daily plus placebo via ELLIPTA. Following the run-in period, subjects will be randomized to receive one of the following study treatments for 84 days: 1) FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning plus two inhalations of placebo to match budesonide/formoterol via MDI, twice daily plus placebo to match tiotropium via HandiHaler once daily in the morning or 2) Budesonide/formoterol 320/9 mcg via MDI, twice daily plus tiotropium 18 mcg via HandiHaler once daily in the morning plus placebo via ELLIPTA once daily in the morning. Subjects will then enter a one week follow-up period. The total duration for a subject in the study will be approximately 17 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies.

When patients get an attack of COPD, one of the main treatments is regular nebulised medications called bronchodilators. These medications act by opening up the airways allowing patients to breathe easier and to reduce shortness of breath. Newer nebulisers may increase the amount of medication that gets into the lungs compared to the standard nebuliser usually used in hospital. This study is being done to assess whether increasing the amount of medication getting into the lungs using these newer nebulisers will help patients recover from a COPD exacerbation.