EUCTR2015-000114-22-PL进行中（未招募）1 期
A 26-week, randomized, double blind, parallel-group multicenter study to assess the efficacy and safety of QVA149 (110/50 µg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- •- Patients who have signed Informed Consent Form prior to initiation of any study-related procedure.
- •- Male and female adults aged = 40 years.
- •- Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3)according to the 2014 GOLD Guidelines.
- •- Patients with a post-bronchodilator FEV1 =40 and < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC <0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 µg of salbutamol).
- •- Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for = 6 months at screening.
- •- Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 700
排除标准
- •- Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don’t meet the acceptability
- •- Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1.
- •- Patients who developed a COPD exacerbation of any severity either 6 weeks before the
- •screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
研究者
相似试验
进行中（未招募）
1 期
Evaluation of the efficacy and safety of QVA149 (110/50 µg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPDEUCTR2015-000114-22-GRovartis Pharma Services AG1,000
进行中（未招募）
1 期
Evaluation of the efficacy and safety of QVA149 (110/50 µg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPDChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 19.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855EUCTR2015-000114-22-NLovartis Pharma Services AG1,000
进行中（未招募）
1 期
Evaluation of the efficacy and safety of QVA149 (110/50 µg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPDChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 19.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855EUCTR2015-000114-22-DKovartis Pharma Services AG1,000
进行中（未招募）
1 期
Evaluation of the efficacy and safety of QVA149 (110/50 µg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPDChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 19.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855EUCTR2015-000114-22-HRovartis Pharma Services AG1,000
进行中（未招募）
1 期
Evaluation of the efficacy and safety of QVA149 (110/50 µg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPDEUCTR2015-000114-22-LTovartis Pharma Services AG1,000