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Pulmonary Emphysema clinical trials

View clinical trials related to Pulmonary Emphysema.

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NCT ID: NCT00395083 Terminated - COPD Clinical Trials

Bronchitis and Emphysema Advice and Training to Reduce Hospitalization

BREATH
Start date: July 2006
Phase: Phase 2
Study type: Interventional

EXECUTIVE SUMMARY: Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention incorporating self-management education, an action plan, and case-management to decrease the risk of hospitalizations due to chronic obstructive pulmonary disease (COPD) among veterans with severe COPD. Hypotheses: Primary Hypothesis: Veterans with COPD who receive a self-management program incorporating education sessions, development of an action plan, and case-management will have a decreased risk of COPD hospitalization compared to standardized COPD care. Primary Objective: In an intent-to-treat analysis, determine the efficacy of a comprehensive self-management program for reducing the risk of COPD hospitalization in veterans with severe COPD in comparison to patients receiving standardized COPD care. Secondary Hypotheses: Compared with standardized COPD care, veterans with COPD who receive a comprehensive self-management intervention will have: A) decreased health-related costs resulting from decreased hospitalizations and outpatient utilization, B) decreased hospitalization rates and average length of stay due to both COPD and all-cause admissions, and C) improvement in a set of outcomes including mortality, health-related quality of life, medication adherence, patient satisfaction, disease knowledge, skill acquisition and self-efficacy. Secondary Objectives: To evaluate the healthcare costs, hospitalization days, mortality, adherence, and health outcomes of a comprehensive self-management program compared to standardized COPD care among patients with severe COPD measured by: A)Healthcare-related costs B)Health services use due to COPD and to all causes C)Clinical outcome measures 1. Mortality 2. Health-related quality of life measured by generic and COPD-specific measures 3. Patient satisfaction 4. Medication adherence 5. Disease knowledge, skill acquisition and self-efficacy In the proposed study, 960 veterans with severe COPD hospitalized in the previous year will be randomly assigned to either a comprehensive case management program or standardized COPD care. The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. Patients allocated to the control arm will receive standardized care that incorporates guideline-based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler. The study will be conducted in 2 phases, a 12-month feasibility study conducted at 6 VA sites followed by the full study in which an additional 8 sites will enroll patients over the next 24 months. As a result, 180 patients will be initially enrolled in the feasibility study over the first year and the remaining 780 patients will be enrolled in the second and third years of the study when the full study is implemented. Subjects will be followed until the completion of the study, for at least one, and up to four years. The primary outcome is time to first COPD hospitalization.

NCT ID: NCT00391612 Active, not recruiting - Emphysema Clinical Trials

EASE Trial: Exhale Airway Stents for Emphysema

EASE
Start date: May 2006
Phase: Phase 3
Study type: Interventional

This is an international clinical research study evaluating the safety and effectiveness of a new procedure called airway bypass. The goal of this research is to see if airway bypass can relieve hyperinflation (overfilling) of the lungs, thereby improving lung function and reducing shortness of breath in patients with severe homogeneous (diffuse) emphysema. "EASE" stands for Exhale Airway Stents for Emphysema.

NCT ID: NCT00347659 Completed - Pulmonary Emphysema Clinical Trials

US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

Start date: June 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.

NCT ID: NCT00307281 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Emphysema Research Registry and Biosample Repository

Start date: August 2000
Phase:
Study type: Observational [Patient Registry]

The Comprehensive Lung Center (CLC) at the University of Pittsburgh Medical Center (UPMC Health System) provides patients with any type of breathing or lung disorder a full range of diagnostic and therapeutic services. The Emphysema/COPD Research Center (ECRC) is a specialty clinic, within this center, that attempts to advance the understanding of emphysema and to evaluate new therapies for patients with emphysema. The Emphysema Research Registry will enable pulmonary research physicians to: 1) gather information and create a research registry of people who have been diagnosed with emphysema; 2) utilize this research registry with the purpose of conducting research that attempts to advance the understanding of emphysema and to evaluate new therapies; and, 3) use the research registry to identify potential candidates for future research programs. These aims will be achieved by the collection of DNA (genetic material)for analysis and storage in addition to pulmonary function tests and other medical information.

NCT ID: NCT00269087 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

Start date: January 28, 2005
Phase: Phase 3
Study type: Interventional

This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

NCT ID: NCT00261833 Completed - Emphysema Clinical Trials

Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency

Start date: March 2006
Phase: Phase 4
Study type: Interventional

This is a randomized, placebo-controlled, double-blind, multicenter phase III/IV study to compare the efficacy and safety of Zemaira® with placebo in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The effect of Zemaira® on the progression of emphysema will be assessed by the decline of lung density, measured by computed tomography (CT).

NCT ID: NCT00233051 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Evaluating Genes in Sputum to Measure Drug Response in COPD

Start date: April 2003
Phase: N/A
Study type: Interventional

The purpose of this research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD. We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This study is designed to determine whether changes in expression of previously-identified inflammatory markers in induced sputum can be detected in response to drug therapy in COPD and to evaluate potential differences in the expression of these markers in adult smokers with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic analysis of therapeutic response as well. Changes in sputum gene expression in response to treatment will be the primary outcome variable in this study. Secondary outcomes will include changes in lung function, as well as changes in induced sputum inflammation. These endpoints will be evaluated before and directly after 6 weeks of randomly-assigned treatment with either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.

NCT ID: NCT00207337 Completed - Emphysema Clinical Trials

Exhale (R) Stent for Emphysema

Start date: July 2004
Phase: Phase 2/Phase 3
Study type: Interventional

Current treatment for emphysema is limited to measures that include inhaled oxygen, bronchodilators, anti-inflammatory drugs and pulmonary rehabilitation. Highly invasive procedures such as lung volume reduction surgery or lung transplantation are also performed. Treatment using the Exhale Drug-Eluting Stent (DES) is a minimally invasive bronchoscopic treatment that has the potential to reduce shortness of breath in emphysema patients. This study tests the safety and effects of Exhale DES in the treatment of patients with emphysema.

NCT ID: NCT00205920 Terminated - Pulmonary Emphysema Clinical Trials

Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

Start date: May 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effective dose of the Aeris BLVR System in patients with advanced emphysema.

NCT ID: NCT00205907 Terminated - Pulmonary Emphysema Clinical Trials

Israeli 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

Start date: January 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.