Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01541852

Losmapimod in Chronic Obstructive Pulmonary Disease Patients Stratified by Fibrinogen. — EVOLUTION  

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
An Evaluation Of Losmapimod in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Systemic Inflammation Stratified Using Fibrinogen (EVOLUTION)

Clinical Trial Summary

The main purpose of this study is to determine the effect of Losmapimod on blood vessels in patients with Chronic Obstructive Pulmonary Disease (COPD). Although COPD is a lung disease, it is also associated with an increased risk of cardiovascular disease (e.g. heart attacks and stroke). The investigators believe that this is a result of inflammation within the body, which damages the lining (endothelium) and walls of blood vessels. These changes can promote the development of fatty deposits within the walls of arteries (atherosclerosis) which can rupture and block arteries causing damage.

Clinical Trial Description

The study aims to enrol sufficient COPD subjects (stratified by fibrinogen level) so that 60 patients complete the study. Study patients will have a 50% chance of receiving either Losmapimod or Placebo. Patients will be expected to attend for up to 12 visits, over a 24 week period. The visits consist of an initial screening visit, and 2 pre-dose imaging visits to include a PET-CT scan and an optional MRI scan. The next 7 visits (at 2-4 weekly intervals) involve blood tests and safety evaluations. A number of procedures including heart tracings (ECGs), non-invasive vascular measurements and lung function tests at the start and at the end of the study. Repeat imaging with PET-CT and MRI will be performed at the end of the study and a follow-up visit.

The purpose of the study is to see if the study medication has a beneficial effect on vascular function and structure. It is envisaged that this trial will help define more evolutionary biomarkers to focus on to help COPD patients in the future. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01541852
Study type Interventional
Source Cambridge University Hospitals NHS Foundation Trust
Contact
Status Completed
Phase Phase 2
Start date June 2012
Completion date February 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy