RUSSE / Russian Spiriva® Safety & Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks
研究概览
简要总结
At the moment, there is hardly any structured safety and efficacy data collection on Tiotropium in Russia. Therefore, the objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 µg tiotropium inhalation capsules) delivered by HandiHaler®, in a national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in a real life setting over the 8 weeks.
详细描述
The objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 µg tiotropium inhalation capsules) delivered by HandiHaler®, in national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in the real life setting over the 8 weeks.
Study Hypothesis:
Primary interest is given to observe change from baseline in post-dose FEV1 after 8 weeks.
Comparison(s):
The objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 mcg tiotropium inhalation capsules) delivered by HandiHaler®, in national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in a real life setting over the 8 weeks.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years and older male and female ambulatory outpatients being seen in a participating physicians office for routine care
- •Patients not previously treated with the Tiotropium
- •Patients with clinical diagnosis of all stages of Chronic Obstructive Pulmonary Disease according to the current National Guidelines / 2004
- •Current smokers or ex-smokers with a smoking history of >=10 pack years
排除标准
- •Uncooperative patients as judged by the physician,
- •Patients that have any condition which, according to the participating physicians opinion, might decrease the chance of obtaining satisfactory data to achieve the objectives of the observation,
- •Patients with history of known preexisting or concomitant non-obstructive lung disease (e.g., sarcoidosis, tuberculosis, lung cancer),
- •Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems,
- •Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva®'s Russian package insert, such as:
- •Patients with known narrow-angle glaucoma,
- •Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction,
- •Patient with known moderate to severe renal impairment (creatinine clearance less than 50 ml/min),
- •Patients with a history of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium or to any component of this product,
- •Pregnant or nursing women.
结局指标
主要结局
Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks
时间窗: baseline and final visit (8 weeks)
Forced expiratory volume in 1 second (FEV1) post-dose response at the end of the observation (Visit 3/week 8) versus (vs.) baseline (Visit 1/week 0)
次要结局
- Change From Baseline for Forced Vital Capacity After 8 Weeks(baseline and final visit (8 weeks))
- Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks(Visit 1 to Visit 3 (baseline and 8 weeks))
- Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS)(final visit (8 weeks))
- Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS(final visit (8 weeks))
- Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS(final visit (8 weeks))
- Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS(final visit (8 weeks))