Severe Prospective Observational Study of COPD in Catalonia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
- 主要终点
- Assess the natural history and prognosis of severe COPD
研究概览
简要总结
Multicenter observational study to characterize and follow-up a cohort of patients with severe chronic obstructive pulmonary disease (COPD) in Catalonia
详细描述
Creation of the first multicenter observational study in Catalonia to characterize and follow-up of patients with severe chronic obstructive pulmonary disease. The follow-up will be up to 5 years, with a first initial visit and control visits every year. All patients will be recruited from respiratory departments from major hospitals from Catalonia, a region with approximately 8 million inhabitants and a wide web of public hospitals.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent: a signed and dated written informed consent prior to study participation
- •Age: Subjects 35 years of age or order at visit
- •Severe COPD diagnosis: an established severe COPD defined by spirometry values:
- •A post-albuterol/salbutamol FEV1/FVC ratio of <0.70 at visit
- •FEV1: forced expiratory volume at one second FVC: forced vital capacity.
- •A post-bronchodilator FEV1 < 50% predicted normal
- •Smoking history: ≥ 10 pack-years at visit 1
- •Stable phase of the disease (not less than 4 weeks of stability prior visit 1)
排除标准
- •Subjects not giving written informed consent.
- •Subjects at risk of non-compliance, or unable to comply with the scheduled visits.
- •Subjects affected mainly by another severe chronic respiratory disease that justifies the ventilatory alteration, for example pulmonary fibrosis or severe bronchiectasis
- •Subjects with carcinoma that has not been in complete remission for at least 5 years.
- •Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
结局指标
主要结局
Assess the natural history and prognosis of severe COPD
时间窗: Up to 5 years
Assess the decline in lung function, frequency and severity of exacerbations and survival over a period of 5 years
Cohort creation in Catalonia
时间窗: Up to 5 years
Creation of a long follow-up (5 years) cohort of severe COPD patients in Catalonia
Describe the demographic and clinical characteristics of patients with severe COPD in Catalonia.
时间窗: Up to 5 years
Identify the distribution of sex, age, severity of lung function impairment, treatment administered and comorbidities of severe COPD patients
次要结局
- Importance of comorbidities in the evolution of COPD(Up to 5 years)
- Impact of exacerbations and chronic bronchial infection on the evolution of COPD(Up to 5 years)
- Assess effect of the different treatments, both inhaled and non-inhaled, on the disease progression and according to the patient's phenotype.(Up to 5 years)
研究者
Ferran Morell
president
Fundacio Catalana de Pneumologia