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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT03256552 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD

Start date: January 28, 2015
Phase: Phase 2
Study type: Interventional

The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.

NCT ID: NCT03250689 Terminated - Clinical trials for Pulmonary Disease, Chronic Obstructive

Randomized Study Evaluating the Effect of Danirixin on Neutrophil Extracellular Traps (NETs) in Chronic Obstructive Pulmonary Disease (COPD)

Start date: November 15, 2017
Phase: Phase 2
Study type: Interventional

The inflammation associated with COPD is characterized by a prominent infiltration of neutrophils in lung tissue and airways. The CXC chemokine receptor type 2 (CXCR2) plays a pivotal role in neutrophil recruitment to the lungs resulting in progressive fibrosis, airway stenosis, and destruction of the lung parenchyma characteristic of COPD. There is a paucity of novel therapies that target these symptoms, and there are no currently available therapies that modify disease progression in COPD. Danirixin (GSK1325756) is a selective CXCR2 antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD and influenza. This study is a mechanistic study which aims to evaluate the effect of danirixin in reducing neutrophil extracellular traps (NETs) formation (or NETosis). Subjects will be randomized (3:1) to receive danirixin hydrobromide (HBr) 35 milligram (mg) orally twice daily or matching placebo for 14 days. Subjects may continue to use rescue medication(s) and inhaled COPD maintenance medication(s) during the study. The study will consist of a screening period of up to 30 days, a 2 week treatment period, and a 1-week follow-up visit via phone call. Approximately 50 subjects will be screened to obtain approximately 24 subjects to complete the study.

NCT ID: NCT03250182 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose

Start date: August 11, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI 320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed following a single dose administration on the first treatment day (Day 1) and will be assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to 28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at least 5 days but no longer than 7 days after the last dose of study drug.

NCT ID: NCT03244137 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease

Start date: September 4, 2017
Phase:
Study type: Observational

Chronic obstructive pulmonary disease is a leading cause of mortality worldwide. It is a systemic disease which includes pulmonary, cardiac, muscular, digestive and cognitive impairments. Pulmonary rehabilitation is a symptomatic treatment to reduce dyspnea and functional incapacity. However, it effects on cognitive dysfunction are not well known. The aim of this study is to assess the effects of a comprehensive pulmonary rehabilitation program on cognitive dysfunction in patients with severe to very severe chronic obstructive pulmonary disease using the Montreal Cognitive Assessment tool.

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: NCT03243994 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

Aim: To investigate whether patients with pulmonary hypertension have reduced absorption capacity compared to COPD patients without cor pulmonale potentially due to venous obstruction in the portal vein system. The presence of cor pulmonale was determined by echocardiography. The concentration of D-xylose and zinc were measured in peripheral blood one, two and three hours after ingestion and used as markers of absorption. Furthermore, urine was collected for five hours to determine the amount of excreted D-xylose.

NCT ID: NCT03243760 Terminated - Clinical trials for Pulmonary Disease, Chronic Obstructive

Dose Escalating Study of CCI15106 Inhalation Capsules in Healthy Subjects and Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: February 10, 2016
Phase: Phase 1
Study type: Interventional

This study will be the first administration of CCI15106 capsules for inhalation to humans. The primary objective of the study is to investigate the safety and tolerability of single and repeat escalating doses of CCI15106 in healthy subjects and patients with moderate chronic obstructive pulmonary disease (COPD). The intention of this study is to provide sufficient confidence in the safety of the molecule delivered by inhalation to inform progression to further repeat dose and proof of concept studies. This will be a three-part study. Part 1 will investigate single ascending doses and Part 2 repeat ascending doses in healthy subjects. In Part 3, a single dose will be administered to patients with moderate COPD. There will be screening period of up to 30 days. The treatment period will be 3 days for Parts 1 and 3 and 16 days for Part 2. Follow-up will be performed within 30 days after the last dose.

NCT ID: NCT03240575 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus

Start date: August 14, 2017
Phase: Phase 4
Study type: Interventional

The primary objective of the trial is to show superiority in lung function of once daily (2 inhalations) treatment with orally inhaled tiotropium+olodaterol fixed dose combination to twice daily (one inhalation) treatment with fluticasone propionate+salmeterol fixed dose combination over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD). A Digital Health (DH) exploratory study has been integrated into the main study as a site specific study. The DH exploratory study will be performed at a single site; the site is also participating in the main study. The DH exploratory study site will enter (randomize) approximately 20 patients (subjects) (in addition to the patients to be enrolled in the main study at this site). The patients enrolled in the DH exploratory study are not considered to be part of the main study (i.e. data collected in the DH exploratory study will be analyzed separately from the data collected in the main study).

NCT ID: NCT03240315 Active, not recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Personalized Prediction Strategy for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Start date: August 1, 2016
Phase:
Study type: Observational

This is a 3 year longitudinal study to establish a personalized prediction and prevention system for acute exacerbation of chronic obstructive pulmonary disease(AECOPD). Data will be collected which contained with clinical, pathophysiology, etiology and immunology information of chronic obstructive pulmonary disease(COPD) patients and analyzed by data mining combined with Internet technology.

NCT ID: NCT03237962 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

High Flow Nasal Cannula During Pulmonary Rehabilitation

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

The primary purpose of this study is to compare and assess the immediate and long-term effects on pulmonary rehabilitation training with the usage of HFNC or conventional oxygen therapy device. The hypotheses was, with high flow nasal cannula usage while exercising, the physiological outcome measurements would be better than conventional oxygen therapy device. Also, the usage of HFNC can immediately increase patient's exercising endurance and decrease dyspnea caused by exercising.