EUCTR2012-003607-36-CZ进行中（未招募）1 期
A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase 2 Study to Assess the Efficacy and Safety of CNTO 6785 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
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
- •Be male or female and =40 years and =75 years of age.
- •Have moderate to severe chronic obstructive pulmonary disease (COPD, Grade II or Grade III according to the GOLD Guidelines
- •Have persistent COPD symptoms that required repeated (>1) ‘as needed’ use of a short-acting rescue medication within 4 weeks prior to Study Visit 1.
- •Have a diagnosis of chronic bronchitis (defined as sputum production on most days for at least 12 weeks per year for at least 2 successive years) reported by the subject at Study Visit 1.
- •Be able to meet at least 1 of the following 2 criteria: have had at least 2 COPD exacerbations requiring antibiotics and/or systemic corticosteroids in the past 2 years; or be able to spontaneously produce an adequate sputum sample at Study Visit 1 or Study Visit 2.
- •Be a current or ex-smoker who has a smoking history of at least 10 pack years (10 pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.) at Study Visit 1.
- •Have been treated with stable dose of LABA and/or long-acting anticholinergic bronchodilators alone or in combination with ICS for at least 4 weeks prior to Study Visit 1.
- •Have a percent-predicted post-BD FEV1 =40% and <80%, and a post BD FEV1/FVC <0.70 at Visit 1.
- •Have a post-BD FEV1 >500 mL at Study Visit 1. Participants in the bronchoscopy substudy must have a post-BD FEV1 >800 mL at Study Visit 1 and Study Visit 2
- •No active, old, or latent tuberculosis (TB), and no close contact with active TB patients within 3 months prior to Study visit 1.
- •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 102
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •Has a body mass index (BMI) >32.0 kg/m2.
- •Has another pulmonary disease, eg, asthma, clinically significant bronchiectasis, cystic fibrosis, sarcoidosis, interstitial lung disorder, moderate or severe sleep apnea, or pulmonary hypertension at Study Visit 1.
- •Has a history of granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to Study Visit 1.
- •Has ever experienced life-threatening COPD (eg, intensive care unit [ICU] admission, intubation, non-invasive ventilation).
- •Has had a lung lobectomy, lung cancer surgery, lung volume reduction, or a lung transplant.
- •Has had any of the following respiratory tract conditions within the specified time intervals: pneumonia (as confirmed by chest x-ray findings and treated with antibiotics) within 1 year prior to Study Visit 1; COPD exacerbation that required systemic steroids and/or antibiotics or required hospitalization and was not associated with pneumonia within 6 weeks prior to Study Visit 1; upper or lower respiratory tract infection (including common cold or sinusitis) that was not associated with either pneumonia or COPD exacerbation within 4 weeks prior to Study Visit 1.
研究者
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