EUCTR2015-000982-30-IT进行中（未招募）1 期
Personalized pharmacological treatment of chronic obstructive pulmonary disease based on phenotyping: interventional study - na
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 168 人开始时间: 2021年6月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 168
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
- •1. Male or female, >60 and <85 years of age.
- •2. COPD (stage II-IV) based on GOLD guidelines with a FEV1/FVC < 70% and FEV1 <60% of the predicted value (6).
- •3. Reversibility to 400 µg equivalent of salbutamol <200 ml and <12% predicted value FEV1(6).
- •4. At least one COPD exacerbation in the previous year.
- •5. No acute exacerbations or upper respiratory tract infection in the previous 4 weeks.
- •6. No history of systemic disease or other pulmonary disease.
- •7. No ICS or systemic glucocorticoids in the previous 4 weeks.
- •8. No history of asthma or atopic disease.
- •9. Allowed treatment for COPD at visit 1: short-acting beta2-agonists alone as needed and LAMA and/or LABA on regular basis. If on different LAMA and/or LABA, at visit 1, patients will be shifted to study bronchodilators as described above.
- •10. Patients able to complete the study.
- •11. Ability to perform reproducible spirometry.
- •12. Patient is an ex smoker and has stopped smoking for at least 6 months.
- •13. Ability of patient to provide informed consent
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 118
排除标准
- •1. Inability to provide informed consent
- •2. Patient is hospitalized
- •3. Major surgical procedure in the previous four weeks
- •4. Participation in a clinical trial in the previous four weeks
- •5. Patient is current smoker
- •6. No COPD exacerbation in the previous year.
- •7. Patient has been hospitalized for COPD in the previous two months.
- •8. Other respiratory diseases in addition to COPD
- •9. Glaucoma
- •10. Any illness that could be immediately life threatening.
- •11. Upper respiratory infections or exacerbations in the previous 4 weeks.
研究者
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