Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate...
Chronic Obstructive Pulmonary DiseasePrimary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by Annualized rate of acute moderate or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) Pre-bronchodilator FEV1 over 52 weeks compared to placebo Lung function assessments Moderate and severe COPD exacerbations To evaluate safety and tolerability To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)
Clinical Trial to Investigate the Safety and Tolerability of EP395 in Patients With COPD
Chronic Obstructive Pulmonary DiseaseCOPDThe aim of this clinical trial is to investigate the safety and tolerability of oral, once-daily EP395 administration in COPD patients for 12 weeks.
Personalized Exercise Therapy and Self-management Support for Patients With Multimorbidity
OsteoarthritisKnee8 moreChronic conditions such as knee or hip osteoarthritis (OA), chronic obstructive pulmonary disease (COPD), heart failure (HF), coronary heart disease (CHD), hypertension, type 2 diabetes mellitus (T2DM) and depression are among the leading causes of global disability and affect hundreds of millions of people around the world. In recent years, multimorbidity, commonly defined as the co-occurrence of at least two chronic conditions, has also gained interest due to its substantial impact on the person and society. Despite the significant burden of multimorbidity, little is known about how to treat this effectively. A 2016 Cochrane systematic review found that interventions targeting populations with specific combinations of conditions and addressing specific problems such as functional difficulties may be more effective. Exercise therapy is a treatment addressing functional limitations that is a safe and effective treatment of at least 26 chronic conditions, including OA, HF, CHD, hypertension, T2DM, COPD and depression. Furthermore, self-management support is increasingly recognized as an essential component of interventions to improve outcomes in patients living with multimorbidity and to support the long-term adherence to exercise. A new systematic review found that exercise seems effective in people with multimorbidity (the conditions included in the current study), however highlighting the need for further high-quality RCTs. The aim of this randomized controlled trial (RCT) is to investigate the effects of a personalized exercise therapy and self-management support program in addition to usual care on self-reported, objectively measured and physiological outcomes in people with multimorbidity (i.e. at least two of the following conditions: OA (knee or hip), heart condition (HF or CHD), hypertension, T2DM, COPD and depression). The primary endpoint is 12 months, but 4- and 6-month follow-ups are included as well and a 12-month health economic evaluation of the program will be conducted. Prior to the RCT, a feasibility trial of 20 people with multimorbidity, all undergoing the personalized exercise therapy and self-management support program, will be conducted using the same methods as in the RCT, but primarily focusing on feasibility outcomes (recruitment, retention, adherence to treatment, burden of outcomes, improvements in outcomes, adverse events). This will start recruitment in Feb 2021 and end August 2021. The MOBILIZE project has received funding from several foundations, including the European Research Council (ERC) under the European Union's Horizon 2020 research and innovation program (grant agreement No 801790).
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants...
Chronic Obstructive Pulmonary Disease (COPD)Chronic BronchitisThis is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.
Effects of High Flow Nasal Cannula on Sputum Clearance in Acute Exacerbation of Chronic Obstructive...
Chronic Obstructive Pulmonary DiseaseCOPD Exacerbation1 moreAcute exacerbation of COPD usually presents with more sputum production leading to worsening airflow obstruction. Often patients complain of sensation of sputum (phlegm) stuck in throat, which leads to worsening cough and respiratory distress. In an acute exacerbation setting high flow nasal cannula (HFNC), which is a modality that provides humidified and warm oxygenated air at flow of upto 60L/min, has shown to reduce blood carbon dioxide level and respiratory rate. However, studies investigating other effects of HFNC in this setting are lacking. To investigators' knowledge, this is the first study investigating effects of HFNC on sputum clearance in COPD patients. The purpose of the study is to determine the effects of HFNC on sputum clearance in acute exacerbation of COPD. Primary objective of the study is to determine whether HFNC improves clearability and wettability of sputum produced during acute exacerbation of COPD. Secondary objectives of the study include subjective assessment of cough severity as well as need for escalation of care after HFNC use versus conventional flow nasal oxygen (CFNO) use.
Mesenchymal Stem Cells in the Treatment of Subjects With Advance Chronic Obstructive Pulmonary Disease...
Chronic Obstructive Pulmonary DiseaseResearchers are trying to understand the effects of mesenchymal stem cells therapy in subjects with advance chronic obstructive pulmonary disease
Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol...
COPDThe goal of this clinical trial is to compare the acute bronchodilator effect of pMDI formed Ipratropium / Levosalbutamol 20 mcg / 50 mcg fixed dose combination or pMDI formed Salbutamol 100 mcg Inhaler and Ipratropium 20 mcg Inhalation Aerosol in combination in stable moderate-severe-very severe COPD patients.
Mesenchymal Stem Cells for The Treatment of Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease ModerateThe clinical study with UMC119-06 is designed to investigate the safety in patients with Chronic Obstructive Pulmonary Disease. This will be a dose escalation, open label, single-center study in adult with chronic obstructive pulmonary disease. UMC119-06 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of chronic obstructive pulmonary disease.
Pulmonary Rehabilitation During Acute Exacerbations of Chronic Obstructive Pulmonary Disease: a...
Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseThis study aims to i) assess the short-, mid- and long-term effectiveness of a patient-centred community-based pulmonary rehabilitation (PR) programme during during acute exacerbations of chronic obstructive pulmonary disease (AECOPD); ii) establish the minimal clinical important differences for PR in AECOPD for clinical and patient-reported outcome measures; and iii) evaluate patients' perspectives and self-reported impact of the PR programme. Patients with AECOPD will be recruited via clinicians at hospitals and primary care centres. Sociodemographic, anthropometric and clinical data; vital signs and peripheral oxygen saturation; symptoms (dyspnoea, fatigue, cough and sputum); lung function; physical activity level; peripheral muscle strength; functional status; exercise tolerance; impact of the disease and health-related quality of life will be collected within 24h-48h of the AECOPD diagnosis. Then, patients will be randomly allocated to either conventional treatment or conventional treatment plus PR. After 3 weeks, all outcome measures will be reassessed. Additionally, follow-ups at 2, 6 and 12 months will be performed through phone calls to assess the number of recurrent AECOPD, healthcare utilization and mortality. Conventional treatment will consist on daily medical treatment prescribed by the physician (i.e., medication). Community-based PR will involve 6 sessions (2 times per week) of breathing retraining and airway clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training, education and psychosocial support. It is expected that, by including PR in the treatment of patients with AECOPD, they will express greater improvements in a shorter period of time and experience a decrease number of re-exacerbations and healthcare utilization.
A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With the Hydrofluoroolefin...
Chronic Obstructive Pulmonary Disease (COPD)This is a 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with moderate to very severe COPD.