COPD Disease Burden, Patient Characteristics, Maintenance Treatment Patterns and Factors Influencing Treatment Decisions in China Tier 2 and Tier 3 Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,507
- 试验地点
- 1
- 主要终点
- Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline
研究概览
简要总结
This observational study will be conducted in COPD participants in Tier 2 and 3 hospitals in China to gain an understanding of the complex COPD management and physician's treatment strategy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline
时间窗: At Baseline (Day 1)
Participants who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment, Long-Acting Muscarinic Antagonist (LAMA), Long-Acting Beta-Agonist (LABA), LABA/LAMA, inhaled corticosteroid (ICS)/LABA, Triple therapy (ICS/LABA/LAMA, Single Inhaler Triple Therapy \[SITT\]), Multiple Inhaler Triple Therapy (MITT), Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. The measurement at Baseline visit (Day 1) was defined as Baseline. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months
时间窗: At 3 months
Participants who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment, LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1)
时间窗: At Week 1
Participants with moderate acute exacerbation requiring no hospitalization, who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment, LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days)
时间窗: At Discharge follow-up (up to 28 days)
Participants with acute exacerbation requiring hospitalization who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment. LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).
次要结局
- Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline(At Baseline (Day 1))
- Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline(Within 1 year prior to Baseline (Day 1) visit)
- Number of Participants With COPD Medication History(At Pre-Baseline (Within 1 month before Baseline [Day 1] visit))
- Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point(At 3 months)
- Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point(At 3 months)
- Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group(Baseline (Day 1))
- Number of Participants With at Least One Co-morbidity(Up to 3 months)
- Number of Participants by Their Socio-economic Characteristics(Baseline (Day 1))
- Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points(Baseline (Day 1), Week 1, Discharge follow-up (up to 28 days) and at 3 months)
- Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline(At Baseline (Day 1))
- Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same(Up to 3 months)
- Number of Participants Receiving COPD Maintenance Treatment at 3 Months(At 3 months)