EUCTR2010-019695-76-EE进行中（未招募）不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod (GW856553) Tablets Administered Twice Daily compared with Placebo for 24 Weeks in Adult Subjects with Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 675
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.COPD diagnosis: Subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004].
- •2.Severity of Disease:
- •Subjects with a measured post-salbutamol/albuterol FEV1/FVC ratio of =0.70 at Screening (Visit 1) [Pelligrino, 2005]
- •Subjects with a measured post-salbutamol/albuterol FEV1 <80% of predicted normal values calculated (via centralised vendor equipment) using NHANES III reference equations [Hankinson, 1999] at Screening (Visit 1).
- •3.Six minute walk distance (6MWD): Subjects with a 6MWD < 350m at each Screening walk. In the opinion of the investigator, the subject’s exercise limitation must be primarily due to their COPD. Patients must be able to perform this test without the use of a walking aid or external oxygen supply.
- •4.Type of subject: Male or female outpatients aged >40 years of age at Screening (Visit 1). (Contraceptive conditions apply)
- •5.Tobacco use: Subjects with a current or prior history of ?10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- •One pack year = 20 cigarettes smoked per day for 1 year or the equivalent.
- •Number of pack years = (number of cigarettes per day/20) x number of years smoked
- •6.Liver criteria: Subjects with the following liver function test values:
- •aspartate transaminase (AST) or alanine transaminase (ALT) <2x Upper Limit Normal (ULN).
- •alkaline phosphatase (alk phos), and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •7.Electrocardiography (ECG): Subjects must have a QTc <450 msec* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be <480msec* on baseline ECG. Subjects with other ECG findings will be excluded if warranted at the discretion of the investigator. QTc readings will be QTcF and machine-read (manual over-reads may be requested by Investigators if interpretation of the machine-read output requires further interpretation). The QT correction formula used to determine inclusion and discontinuation should be the same throughout the study.
- •*Based on single or average QTc value of triplicate ECGs obtained over a brief recording period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnancy: Women who are pregnant or lactating or are planning to become pregnant during the study.
- •2.Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
- •3.?1-antitrypsin deficiency: Subjects with ?1-antitrypsin deficiency as the underlying cause of COPD.
- •4.Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. Subjects with allergic rhinitis are not excluded.
- •5.Lung resection: Subjects who have undergone lung resection surgery (e.g., lung volume reduction surgery or lobectomy).
- •6.Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Screening (Visit 1) if a chest X-ray or CT scan is not available within 12 months prior to Visit 1. For sites in Germany, if a chest X-ray (or CT scan) is not available in the 12 months preceding Screening (Visit1), the subject will not be eligible for the study.
- •7.Recent exacerbation of COPD: Subjects with poorly controlled COPD which required the use of antibiotics, systemic corticosteroids and/or emergency treatment or hospitalisation within 12 weeks prior to Visit 1.
- •8.Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 12 weeks prior to Visit 1.
- •9.Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., ?12 hours per day) is not exclusionary.
- •10.Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or other non-invasive positive pressure ventilation (NIPPV) device.
- •11.Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks prior to Screening (Visit 1) or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study.
- •12.Other diseases/abnormalities: Any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- •13.Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not exclude a subject if it has been considered cured within 5 years since diagnosis.
- •14.Liver: Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •15.Hepatitis: A positive Hepatitis B surface antigen or positive Hepatitis C antibody at Screening (Visit 1).
- •16.Obesity: Subjects who have a Body Mass Index (BMI) > 35.
- •17.Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., lactose, magnesium stearate).
- •18.Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
- •19.Medication prior to spirometry: Subjects who are medically unable to withhold their salbut
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