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Emphysema clinical trials

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NCT ID: NCT03474471 Completed - Emphysema Clinical Trials

A Trial on the Effects of Bronchoscopic Lung Volume Reduction in Severe Emphysema.

SOLVE
Start date: July 31, 2018
Phase: N/A
Study type: Interventional

Rationale: The published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment in the GOLD-COPD2017 guidelines. Interaction with pulmonary rehabilitation, impact on patient-reported outcomes, physical activity, and extrapulmonary consequences are all topics to gain more insight in. This importantly, to further develop and optimize this innovative and personalized therapy. Objective: To study in detail the impact and optimal timing of pulmonary rehabilitation (PR) on exercise physiology and patient-reported outcomes and the impact of the bronchoscopic lung volume reduction treatment using endobronchial valves (EBV) on cardiopulmonary function, metabolism and changes in body composition. Study design: This study is a randomized controlled trial with 3 study-arms. Group 1 will first follow a PR program and afterwards undergo the EBV treatment. Group 2 will first undergo the EBV treatment and approximately 8 weeks later will follow a PR program. Group 3 will only undergo the EBV treatment (and can choose to follow a PR program after completing the 6 month FU visit). Study population: The study population exist of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment using one-way valves. Intervention: Most patients will undergo a bronchoscopic lung volume reduction treatment using endobronchial valves and a pulmonary rehabilitation program. One group of patient will under a bronchoscopic lung volume reduction treatment using endobronchial valves and can choose whether they also want to follow a pulmonary rehabilitation program afterwards. Main study parameters: The main study parameter is the difference in change in endurance time measured by an endurance cycle test between the EBV treatment group and the bronchoscopic lung volume reduction + rehabilitation group (EBV+PR).

NCT ID: NCT03360396 Completed - Emphysema Clinical Trials

Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema

ELEVATE
Start date: May 7, 2018
Phase: N/A
Study type: Interventional

This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.

NCT ID: NCT03244059 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies

BOTEGA
Start date: August 9, 2018
Phase: Phase 2
Study type: Interventional

This is intended to be an initial "proof-of-concept" study to show feasibility, validate assays and approaches, and explore dosing and safety of belimumab in pulmonary emphysema patients who have clinically relevant (and quantifiable) autoimmune responses. The primary goal is to determine effects of belimumab on levels of autoantibodies against glucose regulated protein 78 (GRP78) among patients with pulmonary emphysema attributable to cigarette smoking. The investigators hypothesize that belimumab treatment will safely reduce circulating levels of autoantibodies that are associated with emphysema, and comorbidities of this lung disease, including atherosclerosis.

NCT ID: NCT03205826 Completed - Emphysema or COPD Clinical Trials

Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Rationale: The Chartis® ( Pulmonx, CA, USA) measurement system is a tool to assess interlobar collateral ventilation during bronchoscopy. Assessing collateral ventilation is important when you intend to treat a patient with endobronchial valves. Chartis measurement of collateral ventilation can be performed under both conscious sedation as well as general anesthesia. There is no consensus on what is the preferred method of anesthesia for Chartis measurements in the literature. Objective: In this project we want to investigate whether there is a difference in Chartis measurement outcomes between these two methods of anesthesia: conscious sedation and general anesthesia. Study design: This study will be a single center observational study Study population: The study population exists of patients with severe emphysema who undergo collateral ventilation assessment before bronchoscopic lung volume reduction treatment with one-way endobronchial valves. Intervention: All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia. Main study parameters/endpoints: Our primary outcome measure is the failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.

NCT ID: NCT03114020 Completed - Emphysema Clinical Trials

Efficacy/Safety of HA Inhalation Solution for Hereditary Emphysema in Patients With Alpha-1 Antitrypsin Deficiency

Start date: March 22, 2017
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of administering repeated doses of Hyaluronic Acid Inhalation Solution to subjects with Emphysema that have Alpha-1-Antitrypsin deficiency

NCT ID: NCT03073798 Completed - COPD Clinical Trials

The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis

Start date: March 18, 2013
Phase: Phase 4
Study type: Interventional

Specific Aim: To determine the effectiveness of Roflumilast in improving i) whole right lung and ii) peripheral right lung mucociliary clearance (MCC) in patients with COPD and chronic bronchitis. Hypothesis: Roflumilast increases mucociliary clearance in patients with chronic bronchitis. Study Design: This will be a double-blinded, cross-over randomized controlled trial with 1:1 randomization of 20 individuals with chronic bronchitis. Subjects will undergo baseline MCC then will be randomized to either roflumilast or placebo x 4 weeks, then there will be a 4 week wash-out phase and a second 4 week period of roflumilast/placebo depending on initial randomization. MCC will be conducted at baseline and at the end of each 4 week medication phase.

NCT ID: NCT03008915 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency

Start date: January 2017
Phase: Phase 2
Study type: Interventional

The aim of this study is to test whether aspirin improves endothelial function in alpha-1 antitrypsin deficiency-associated lung disease, measured by pulmonary microvascular blood flow on magnetic resonance imaging (MRI) and with apoptotic endothelial microparticles.

NCT ID: NCT02999685 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients

Start date: September 2016
Phase: N/A
Study type: Interventional

Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.

NCT ID: NCT02935452 Completed - COPD Clinical Trials

Implementing and Evaluating the Genie Tool in COPD

GeCop
Start date: June 8, 2017
Phase: N/A
Study type: Interventional

The Generating Engagement in Network Involvement (GENIE) Tool is designed to support people to find and join social activities in their own neighbourhoods. Evidence has shown that people with more social support have increased ability to manage long term conditions and ill health. Patients with Chronic Obstructive Lung Disease (COPD) have difficulty breathing every day; this is both tiring and makes its difficult to socialise as they did prior to having their condition. COPD can be managed with medicines, and exercise, but will never be cured, so it is considered a 'long term condition.' This study plans to use a social mapping tool (GENIE) with COPD patients that are already part of the community service. The aim of the study is to increase opportunities to socialise and get day to day support outside of the health service. Patients will be offered either the tool, or usual care. If the study is successful then use of health care may reduce in the COPD patients already using the COPD service.

NCT ID: NCT02914340 Completed - Emphysema Clinical Trials

REACH SVS Control Patient Cross-Over Study

Start date: September 2016
Phase: N/A
Study type: Interventional

This is a multicenter, prospective study designed to evaluate performance of the SVS in the REACH SVS control patients. The study is expected to enroll up to 20 patients at up to 12 sites with up to 6 patients per site.