A Phase 2 Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Inhaled JNJ-49095397 (RV568) in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease.

Janssen-Cilag International NV0 个研究点目标入组 200 人开始时间: 2013年8月28日最近更新: 2014年10月7日

适应症

试验速览

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•Men and women of non-child-bearing potential, Global Initiative for Chronic Obstructive Lung Disease (GOLD 2 or 3), forced expiratory volume in one second (FEV1) greater than or equal to 40 less than 80 percent predicted, FEV1/ forced vital capacity (FVC) ratio less than 0.7 - Clinical history of chronic bronchitis. Either two chronic obstructive pulmonary disease (COPD) exacerbations in past two years or ability to produce a spontaneous sputum sample, treated with long-acting beta-2 agonist (LABA)/ long-acting muscarinic antagonists (LAMA), with or without inhaled corticosteroids for at least 12 weeks prior to study entry - Smoker or ex-smoker with at least a 10 pack-year history - No COPD exacerbation that requires change in COPD maintenance medications during the screening period - Not experienced a significant worsening of COPD based on clinical symptoms and by investigations during screening 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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•-Has another pulmonary disease (eg, asthma) or an active infection (eg, tuberculosis)
•-Has experienced life-threatening COPD (eg, requiring intensive care unit [ICU] admission, intubation, or long-term non-invasive ventilation).
•Short-term (less than five days), non-invasive ventilation during a hospitalization for an acute exacerbation of COPD is permitted, provided that non-invasive ventilation was not continued at home.
•- Has right heart failure or oxygen saturation less than 90 percent at rest on room air at screening or requires oxygen therapy on a daily basis for chronic hypoxemia (deficiency of oxygen in blood)
•- History of significant disease or medical illness within 12 months prior to screening
•- Positive serology to human immunodeficiency virus (HIV)-1 or HIV-2, hepatitis B virus, or hepatitis C virus at screening.

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