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

ovartis Pharma Services AG0 个研究点目标入组 1,000 人开始时间: 2015年8月31日最近更新: 2017年10月2日

试验速览

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•- 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

•- 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.

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