Efficacy and Safety of ICS/LABA vs. LAMA/LABA in Patients With Different COPD Phenotypes.
COPDThis is a randomized, blinded, controlled clinical trial for mexican COPD patients. Biomass smoke associated COPD (BS-COPD) clinical spectrum is different to the one seen in tobacco smoke associated COPD (TS-COPD). BS-COPD patients present COPD-asthma phenotype or asthma-COPD overlap syndrome (ACOS), TS-COPD patients present mostly the emphysema phenotype. BS-COPD patients have a greater risk of exacerbations in comparison to the emphysema phenotype. Therefore, individualizing treatment in both phenotypes may be very useful among the clinical practitioners. The investigators expect treatment with FF/V to be superior in preventing COPD exacerbations than the U/V combination in patients with COPD-asthma phenotype; andU/V to be superior than FF/V in patients with the emphysema phenotype. The general objective of the study is to determine the exacerbations outcome in patients with COPD-asthma vs emphysema phenotype patients, treated with both drugs. Secondary objectives include assessment of pulmonary function tests, quality of life, dyspnea and functional capacity change after a 24 weeks treatment.
Comparison of Active Cycle of Breathing Technique and Pursed Lip Breathing With TheraPep
Chronic Obstructive Pulmonary Disease ExacerbationThe purpose of this study is to investigate the short-term effects of two different breathing techniques (the active cycle breathing technique (ACBT) and the pursed lip breathing technique (PLB)) with Thera PEP® on the clearance of secretions and the oxygen saturation of individuals who have recently experienced an acute exacerbation of chronic obstructive pulmonary disease (COPD) in individuals who have recently experienced an acute exacerbation of COPD (COPD). Thirty patients will each have an acute COPD exacerbation seen on them, and then they will be randomly allocated to one of two groups (1. ACBT and PLB; 2. Thera PEP). Participants in a study employing a design known as a within-subject randomized crossover will be given the instruction to carry out each procedure on consecutive days as part of the study. In this study, the dependent variables will include blood pressure, heart rate, oxygen saturation (SpO2), respiratory rate, peak expiratory flow rate (PEFR), visual analog scale (VAS), sputum volume, and the breathlessness, cough, and sputum scale. In addition, the independent variables will include sputum volume (BCSC). The patient's desired course of treatment will also be taken into account. These dependent variables will be examined at three distinct moments in time: at the beginning of the study (the baseline), immediately after treatment, and thirty minutes after treatment has been completed.
The Effectiveness Pulmonary Telerehabilitation and Cognitive Telerehabilitation in COPD Patients...
Severe Chronic Obstructive Pulmonary DiseaseDyspnea10 moreThe aim of our study is to compare the effectiveness of the supervized pulmonary telerehabilitation program and the cognitive telerehabilitation method, which includes pulmonary telerehabilitation methods, in patients with severe stage COPD who have difficulty exercising heavily. The effects of pulmonary and cognitive rehabilitation on dyspnea, muscle strength, functional capacity, quality of life, anxiety and depression levels in this patient group will be examined. The number of studies in the literature in which the pulmonary rehabilitation program was applied as telerehabilitation is insufficient. Considering that this patient group is not motivated and has difficulty in exercising, motor imagery and movement observation methods from cognitive rehabilitation methods may be alternative methods for these patients. Although these methods have been very popular in recent years in terms of researching and demonstrating their effectiveness in various patient groups in the literature, no study has been found in which the effects of these methods have been applied in pulmonary disease groups. This study aims to contribute to the serious gap in the literature on the application of pulmonary telerehabilitation and its effectiveness, and to be an original study by investigating the effectiveness of motor imagery and action observation, which are popular rehabilitation methods of recent years, in COPD patients in the pulmonary disease group for the first time.
Environment Effect on Six-Minute Walk Test Performance
Chronic Obstructive Pulmonary DiseaseAlpha-1 Antitrypsin DeficiencyThe purpose of this research study is to determine the effect of the environment on six-minute walk test performance in individuals with chronic obstructive pulmonary disease due to alpha-1 antitrypsin deficiency. The aim of the study is to determine the environmental impact on physical performance in this population to determine if any factors influence quality of life. This study was developed to evaluate the efficacy of the using the indoor six-minute walk test to determine eligibility for ambulatory oxygen therapy.
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate...
COPDStudy to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Extracorporeal CO2 Removal in Hypercapnic Patients
Pulmonary DiseaseChronic ObstructiveNoninvasive ventilation represents the standard of care for patients with exacerbation of chronic obstructive pulmonary disease. However, NIV fails in almost 30% of the most severe forms of acute hypercapnic respiratory failure and patients must undergo endotracheal intubation and invasive ventilation to restore adequate gas exchange. Under these circumstances, patients may express a clear intention not to be intubated.The aim of this study is to retrospectively assess efficacy and safety of noninvasive ventilation- plus-extracorporeal Co2 removal in patients who fail NIV and refuse endotracheal intubation.
Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine...
COPDThe purpose of this research study is to determine the amount of medicine absorbed in the lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
The Granheim COPD Study - Vitamin D and Strength Training
Chronic Obstructive Pulmonary DiseaseThis study evaluates the effect of vitamin D supplementation on outcomes of 10 weeks progressive strength training in 100 ageing subjects (>45 years of age). Participants will be recruited into two similarly sized strata; one containing COPD patients and one containing healthy subjects of similar age. In each stratum, half the participants will receive vitamin D supplementation and half the participants will receive placebo
Comparison of Tai Chi and Pulmonary Rehabilitation on the Effect of Indacaterol in Treatment naïve...
Chronic Obstructive Pulmonary DiseaseTai-Chi may be a beneficial form of rehabilitation which is acceptable to the Chinese population but no data exist concerning metabolic responses to Tai-Chi in COPD patients. Investigators conduct an Randomized controlled trial to evaluate the synergistic effect of a Long acting β2-agonists with Tai-Chi as a culturally acceptable form of PR in the Asian population. Classical western style pulmonary rehabilitation will serve as a comparator Investigators propose a prospective randomized controlled trial in which 120 bronchodilator naïve participants (Age 40-80 with GOLD II-IV COPD (post-bronchodilator FEV1 ≥ 25% and <80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70) are randomized to receive a 26 weeks course of Indacaterol with either Tai-Chi or conventional Pulmonary Rehabilitation. Only participants who are residents in Xingning city (Guangdong Province, China) will be recruited. Both Tai-Chi and pulmonary rehabilitation will be given by qualified instructors at a rural location in southern China (Xingning). A qualified UK Physiotherapist will also be involved in the management of pulmonary rehabilitation program to further make sure the high quality of pulmonary rehabilitation has been applied. Both arm participants will also receive in an open label fashion Indacaterol 150µg qd. for 6 months giving 2 therapy groups (Tai-Chi/Indacaterol, pulmonary rehabilitation/Indacaterol). The primary endpoint of this study is change in SGRQ between Tai-Chi/Indacaterol and pulmonary rehabilitation/Indacaterol at 14 weeks after entry and the secondary endpoints are change in FEV1% and six minute walk distance. the planned recruitment will be 120 with a view to obtaining 100 completers. The investigators propose the study starts on 31 Dec 2014 and completes on 30 June, 2016.
GSK961081 Alone and With Fluticasone Furoate (FF), Phase 1 (Ph1), Single Dose Regimen (SD), Repeat...
Pulmonary DiseaseChronic ObstructiveBatefenterol (BAT) is a novel bifunctional molecule that combines muscarinic antagonism and beta2-agonism in a single molecule and is in development for the treatment of chronic obstructive pulmonary disease (COPD). FF is a corticosteroid approved as the inhaled corticosteroid (ICS) component of a combination product, with vilanterol (VI), a long-acting beta2-agonist for COPD. In the current study FF will be investigated as an inhaled product in combination with BAT, for treatment of COPD. This study is an open-label, six-way crossover, single and repeat dose study to evaluate the systemic pharmacokinetics, safety and tolerability of FF and BAT when administered via the ELLIPTA™ alone, in combination, or concurrently at 3 times the clinical dose, following a single dose, and at the proposed clinical dose, following repeat doses. This study will consist of screening period, 6 treatment periods, and a follow-up visit. Each subject will have 3 periods in which they receive a single dose treatment regimen (3 inhalations on Day 1 of each single dose study period) and 3 periods in which they receive a single dose treatment regimen followed by a 7-day, once-daily, repeated dose. On Day 1 of those periods, subjects will receive their single dose as 3 inhalations. On Days 2-8, subjects will receive 1 inhalation per day for the repeated dose regimen. There will be a minimum of 7-day washout between each treatment periods. All subjects will receive 9 treatments and follow-up procedures will be done 7 14 days after the last dose. Forty eight healthy subjects will be enrolled into the study, such that approximately 40 subjects complete dosing and PK assessments. The total duration of participation for each subject in this study will be up to 15 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline [GSK] group of companies.