Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- To observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD
研究概览
简要总结
The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.
详细描述
Study details include:
The study duration will be 26 weeks The treatment duration will be 24 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a physician-confirmed diagnosis of COPD
- •With a history of one severe COPD exacerbation or two or more moderate COPD exacerbations in the preceding 12 months.
- •Post-bronchodilator FEV1 should be between ≥30 % to <80% of the predicted normal.
- •Both male and female patients are allowed in the study
- •Female of Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal)
- •A urine pregnancy test must be negative at screening.
- •female participant must follow effective contraceptive method as outlined in protocol
- •Patients should be capable of giving signed informed consent
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.
- •Chest x-ray within 6 months before screening must be acceptable to the investigator. Subjects who have a chest x-ray that reveals clinically significant abnormalities not believed to be due to the presence of COPD should not be included. A chest x-ray must be conducted if the most recent chest x-ray is not available at the time of screening.
- •Patients having moderate to severe exacerbations within 6 weeks before the Screening period.
- •Female patients who are pregnant or lactating or planning a family during the study period.
- •Patients with either a history of hypersensitivity to excipients of the study drug or drugs with a similar chemical structure or class to the study drug.
- •Patients participating in any current or future interventional trial during the study will not be enrolled in the current study.
研究组 & 干预措施
Single arm
It will be a single-arm interventional phase 4 clinical study where participants will receive treatment with Breztri aerosphereTM containing budesonide 160 mcg/ glycopyrronium 7.2 mcg/ formoterol fumarate dehydrate 5 mcg (Breztri aerosphereTM pMDI) two actuations twice daily through oral inhalation for 24 weeks.
干预措施: Breztri Aerosphere (Drug)
结局指标
主要结局
To observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD
时间窗: 24 weeks
Percentage, nature, intensity, seriousness and causal relationship of AEs, SAEs, and AEs leading to discontinuation of study drug will be assessed
次要结局
未报告次要终点