NL-OMON47721已完成3 期
A Randomized, Double Blind, Multi Center, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52 Week Treatment Period in Subjects With Moderate to Very Severe COPD - PT010005 study in patients with moderate to very severe COPD
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Non-child bearing potential (ie, physiologically incapable of becoming
- •pregnant, including any female who is 2 years post-menopausal); or Child
- •bearing potential, has a negative serum pregnancy test at Visit 1, and agrees
- •to acceptable contraceptive methods used consistently and
- •correctly for the duration of the study.
- •* Subjects with an established clinical history of COPD as defined by the
- •American Thoracic Society (ATS)/European Respiratory Society (ERS).
- •* Current or former smokers with a history of at least 10 pack-years of
- •cigarette smoking.
- •* Forced expiratory volume in 1 second (FEV1)/Forced vital capacity
- •(FVC) ratio of <0.70 and FEV1 of <65% predicted normal value
- •calculated using NHANES III reference equations (or reference norms
- •applicable to other regions). Note: this criteria applies to subjects in the
- •PFT sub-study only.
- •* Subjects with history of exacerbations. , Please refer to the study protocol
- •for the complete inclusion criteria list.
排除标准
- •* Significant diseases or conditions other than COPD, which, in the
- •opinion of the Investigator, may put the subject at risk because of
- •participation in the study or may influence either the results of the study
- •or the subject's ability to participate in the study.
- •* Women who are pregnant or lactating, or are planning to become
- •pregnant during the course of the study, or women of childbearing
- •potential who are not using an acceptable method of contraception.
- •* Subjects, who in the opinion of the Investigator, have a current
- •diagnosis of asthma.
- •* Subjects who have been hospitalized due to poorly controlled COPD
- •within 3 months prior to Visit 1 (Screening) or during the Screening
- •Period (Visit 1 to Visit 4).
- •* Subjects who have poorly controlled COPD, defined as acute worsening
- •of COPD that requires treatment with oral corticosteroids or antibiotics
- •within 6 weeks prior to Visit 1 (Screening) or during the
- •Screening Period (Visit 1 to Visit 4).
- •* Immune suppression or severe neurological disorders affecting control
- •of the upper airway or other risk factors that in the opinion of the
- •Investigator would put the subject at substantial risk of pneumonia.
- •* Subjects with a diagnosis of narrow angle glaucoma, who, in the
- •opinion of the Investigator, have not been adequately treated.
- •* Subjects who have a history of hypersensitivity to *2-agonists,
- •budesonide or any other corticosteroid components, glycopyrronium or
- •other muscarinic anticholinergics, or any other component of the IMPs.
- •Please refer to the study protocol for the complete exclusion criteria list.
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