CTRI/2017/03/008185尚未招募3 期
A 24-week Treatment, Randomised, Parallel-group, Double blinded, Double- Dummy, Multicenter Study to Assess the Efficacy and Safety of Aclidinium bromide/Formoterol fumarate compared with Individual Components and Placebo and Aclidinium bromide compared with Placebo when Administered to Patients with Stable Chronic Obstructive Pulmonary Disease - AVANT
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,060
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adult male or non-pregnant, non-lactating female patients aged >=40
- •2. Patients with a diagnosis of COPD (GOLD guidelines, 2015) for a period of at least 6 months prior to Visit 1 (screening)
- •3. Patients with moderate to severe stable COPD (Stage II or Stage III, according to GOLD Guidelines 2015) at Visit 1: post-bronchodilator FEV1 >=30% and < 80% and post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%
- •4. Current or former smokers with a smoking history of >= 10 pack-years
- •5. Patients able to perform repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005 criteria at Visit 1(screening )
- •6. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff and/or site staff) or patients employed by or relatives of the employees of the site or sponsor.
- •2. Previous enrolment or randomisation in the present study
- •3. History or current diagnosis of asthma
- •4. Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to screening or during the run-in period
- •5. Patients hospitalized for COPD exacerbation (an emergency room visit for longer than 24 hours will be considered a hospitalization) within 3 months prior to screening and during the run-in period
- •6. Clinically significant respiratory conditions other than COPD
- •7. Patients who in the Investigators opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started or finished it within 3 months prior to screening
- •8. Use of long-term oxygen therapy (>=15 hours/day)
- •9. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers
- •10. Clinically significant cardiovascular conditions
- •11. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
- •12. Patients with QT corrected interval (QTc) using Fridericia formula (QTcF) (QTc is equal to QT/ Duration in milliseconds between two R peaks of two consecutive QRS complexes (RR1/3) >470 msec as indicated in the centralised reading report assessed at Screening (Visit 1)
- •13. Patients with clinically significant abnormalities in the clinical laboratory tests, ECG parameters (other than QTcF) or in the physical examination at Visit 1 (screening)
- •14. Patients with abnormal liver function tests defined as Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or total bilirubin >= 2.5 times upper limit of normal ranges at screening
- •15. Patient with known non-controlled history of infection with human immunodeficiency virus and/or active hepatitis
- •16. Patient with a history of hypersensitivity reaction to inhaled anticholinergic drugs, sympathomimetic amines, inhaled medication or any component thereof
- •17. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
研究者
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