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Lung Diseases clinical trials

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NCT ID: NCT02112929 Completed - Lung Disease Clinical Trials

Regional Lung Imaging Using Hyperpolarized Xenon Gas

Start date: April 2012
Phase: Phase 1
Study type: Interventional

The investigators aim to use hyperpolarized xenon gas magnetic resonance imaging (MRI) and computed tomography to develop a new technique capable of objectively and quantitatively describing regional and structural lung abnormality. Since this is a relatively novel technique, the investigators first need to acquire imaging and clinical data from a group of participants with normal lungs. The investigators hope to generate an "atlas" of normality, which will form the foundation of future studies to compare with patients suffering from chronic respiratory disease. The investigators also aim to validate the new technique in terms of intra-subject reproducibility.

NCT ID: NCT02109172 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 2014
Phase: Phase 2
Study type: Interventional

This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.

NCT ID: NCT02108925 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of Oxygen Supplementation During Exercise in Chronic Obstructive Pulmonary Disease Patients

Start date: April 2014
Phase: N/A
Study type: Interventional

The project will test the hypothesis that lung ventilation during exercise is unaffected by oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea, heart rate and blood pressure will be studied.

NCT ID: NCT02105974 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 7, 2014
Phase: Phase 3
Study type: Interventional

This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second [FEV1]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.

NCT ID: NCT02105961 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 24, 2014
Phase: Phase 3
Study type: Interventional

This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar levels as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in 1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The total duration of subject participation will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

NCT ID: NCT02105948 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Evaluate Efficacy and Safety of Mepolizumab for Frequently Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: April 15, 2014
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD patients would translate into a reduction of COPD exacerbations. The study will determine the reduction in exacerbations in subjects who are above and below the baseline blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations, despite the use of optimized standard of care background therapy. Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

NCT ID: NCT02103374 Completed - Clinical trials for Severe Chronic Obstructive Pulmonary Disease

Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State

Nebuadom
Start date: January 2012
Phase: Phase 4
Study type: Interventional

Design studies of nebulization in COPD does not respond adequately to the clinically relevant question: the intervention of administering nebulized bronchodilators at home it is likely to make a profit, compared to the standard optimized treatment as defined by the recommendations of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of profit in this context is based on criteria of dyspnea, quality of life, use of health system (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).

NCT ID: NCT02102009 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Nutritional Supplementation in Adults With Chronic Respiratory Disease

OFOS
Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether nutritional support with a complete formula is effective to improve malnutrition and respiratory function in patients with chronic pulmonary disease compared to the standard hospital dietary advise.

NCT ID: NCT02100332 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Cross Sectional Disease/Condition Focused Observational Study on Chronic Obstructive Pulmonary Disease (COPD)

PREFER
Start date: November 2012
Phase: N/A
Study type: Observational

The purpose of this study is to establish the prevalence of comorbidities in Italian patients with chronic bronchitis with at least 2 exacerbations per year, and to document the appropriateness of instrumental diagnostic tests, such as spirometry of these patients.

NCT ID: NCT02098369 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers

PELICAN
Start date: April 2015
Phase: Phase 4
Study type: Interventional

About 1 million individuals in the US have a prescription for supplemental oxygen (O2). Using O2 can prolong life and increase quality of life. Patients often do not use their oxygen as prescribed, which means that they are not benefiting as much as they could be from this therapy. The purpose of this study is to evaluate whether a PEer-Led O2 Infoline for patients and CAregivers (PELICAN) will increase adherence to supplemental oxygen prescription and improve health in patients with chronic obstructive pulmonary disease (COPD).