Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients
Chronic Obstructive Pulmonary Disease (COPD)Pulmonary Rehabilitation became a vital part of management in COPD patients in form of activity modification, dietary and pharmacological optimisation. But access to traditional supervised aerobic (treadmill) walking is debatable fact due to economical and staffing expertise in developing countries like India. The investigators designed a randomised controlled trial to evaluate the effectiveness of ground based walking over traditional treadmill walking in improving quality of life in COPD patients.
Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary DiseaseThis will be an open-label, non-randomized multi-center study designed to assess the safety and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in...
Pulmonary DiseaseChronic ObstructiveThis is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)] when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD) administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the run-in period, subjects who meet the randomization criteria will be randomized to receive UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day 168 (Visit 10). The total duration of subject participation in the study will be approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 7. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.
A 24 Week Efficacy Study of Inhaled Umeclidinium (UMEC) in Patients of Chronic Obstructive Pulmonary...
Pulmonary DiseaseChronic ObstructiveStudies to date provides substantial evidence for the effectiveness for UMEC 62.5 microgram (mcg) as a long term maintenance therapy for the treatment of COPD; this study further evaluates the efficacy and safety of UMEC 62.5 mcg administered once-daily (OD) for 24 weeks via a NDPI compared with placebo in Asian subjects with COPD. Over approximate 27 weeks of entire study duration, 10 study clinic visits will be conducted on an outpatient basis. Pre-screening visit will be conducted for the informed consent form, review demography, COPD history and COPD concomitant medications. Subjects meeting the eligibility criteria at screening will complete a 7 to 14 day Run-in period and will be provided with albuterol/salbutamol as rescue medication on an "as-needed" basis. Further, subjects will be randomized to the UMEC 62.5 mcg or matching placebo in a 1:2 ratio for 24 week treatment period. A follow up for adverse event assessment will be scheduled approximately 7 days after the treatment period or the Early Withdrawal Visit.
Acute Effects of a Flutter Device in COPD
Chronic Obstructive Pulmonary DiseaseChronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible, and is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases, most commonly cigarette smoking. The disease affects not only the large central airways but also the small, more peripheral airways deeper into the lung, defined as less than 2 mm in diameter. Besides medical treatment, physiotherapy plays a major role in treatment and various methods have been suggested to remove airway of secretions. The flutter is a simple and small device shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency oscillation when the expired air passes through it. These vibrations are thought to mobilise airway secretions facilitating their clearance and improving breathing. Standard blowing tests, like spirometry, where patients blow forcedly into a machine, have previously been used to investigate the efficacy of flutter devices. However, spirometry assesses the damage of larger airways but not small airways, also known as the "silent zone" which, crucially, are specifically damaged in COPD. In this study the investigators hypothesise that because the flutter helps clear the airways from the excessive thick mucus produced by COPD patients, these patients may find it easier to breathe and have lower resistance to moving air in and out of their lungs. The main objective of this study is to compare the effect of a flutter or a sham device on small airways damage using impulse oscillometry (IOS), a non-invasive method that, contrary to other common blowing tests, measures small airway resistance during normal breathing. In addition, because COPD is characterised by inflammation, the investigators would also like to measure a gas the patients blow out, nitric oxide (NO) the levels of which reflect airway inflammation. This will give to investigators an insight into the relationship between airway inflammation and small airway function.
Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease
Pulmonary HypertensionChronic Obstructive Pulmonary Disease (COPD)The functional, social, and economic burden of chronic obstructive lung disease (COPD) on the healthcare system is extraordinary. COPD is the fourth leading cause of death in the United States, and some estimates attribute up to $33.2 billion in health care costs to COPD-associated morbidity and mortality annually. The burden of COPD to the VA Healthcare system parallels these findings. According to the VA HSR&D Health Economics Resource Center, COPD ranks 5th among the 40 most common chronic clinical conditions in the U.S. Veteran patient population, is responsible for >14,000 VA hospital admission annually, and increases by $1,051/patient the total annual health care cost burden on the VA Healthcare system. Importantly, COPD is associated with frequent emergency room visitation and/or hospitalization patients. Pulmonary hypertension is a common co-morbid condition that worsen morbidity and mortality in patients with COPD. This study will examine the potential for tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor to improve functional status by decreasing pulmonary hypertension. Results from this study are expected to define the potential use of PDE-5 inhibitors in COPD-induced pulmonary hypertension. If successful, this treatment option may improve quality of life and outcomes for the large number of Veterans afflicted with PH due to COPD.
A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients
Chronic Obstructive Pulmonary Disease (COPD)The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.
Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)...
Chronic Obstructive Pulmonary Disease and Allied ConditionsChronic obstructive pulmonary disease is associated with a low grade systemic inflammatory process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and mortality in COPD. Early changes of vascular integrity can be detected via markers of subclinical atherosclerosis. Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data. The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of systemic inflammation in the peripheral circulation of patients with stable chronic obstructive pulmonary disease.
Long Term Safety Study of NVA237 vs QAB149 in COPD Patients
Chronic Obstructive Pulmonary Disease (COPD)The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum...
Chronic Obstructive Pulmonary DiseaseAsthmaThe aim of this study was to assess the effectiveness for small airway inflammation of 4 weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.