NCT00134979已完成4 期
Efficacy and Safety of Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 847
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
研究概览
简要总结
This study is not being conducted in the United States.
This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease (COPD). This study is also designed to compare the efficacy and safety of therapy with formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.) compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Co-operative males or females with a diagnosis of moderate COPD as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria with an age at onset ≥ 40 years.
- •Current or previous smokers with a smoking history of ≥ 10 pack-years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
- •Pre-bronchodilator forced expiratory volume in one second (FEV1) < 70% of patient's predicted normal value and ≥ 1.00 L, with FEV1/forced vital capacity (FVC) < 70% at Visit
- •A total symptom score from the patient diary of more than 0 on at least 4 of the last 7 days prior to Visit 3
排除标准
- •Pregnant women, nursing mothers, and females of childbearing potential, regardless of whether or not sexually active, who do not use a reliable contraceptive method (oral, mechanical, subcutaneous or surgical contraception).
- •Patients who have been hospitalized for an acute exacerbation of their airway diseases in the month prior to Visit 1 or during screening.
- •Patients who have had a respiratory tract infection within 1 month prior to Visit
- •Patients who develop a respiratory tract infection during the screening period must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 1 month after the resolution of the respiratory tract infection).
- •Patients with concomitant pulmonary disease including a history of cancer (all), pulmonary tuberculosis or congenital bronchiectasis.
- •History of asthma
结局指标
主要结局
Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
次要结局
- COPD "Bad Days" recorded throughout study
- St. George's Respiratory Questionnaire following 12 and 24 weeks of treatment.
- Forced Expiratory Volume in 1 second measured pre-dose, 5 minutes, 2 h and 3 h post dose at day 1, week 12 and week 24
- Forced Vital Capacity measured pre-dose, 5 minutes, 2 h and 3 h post dose at day 1, week 12 and week 24
- COPD "Exacerbation days" recorded throughout study
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00238498Novartis291
已完成
3 期
Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%Diabetes Mellitus, Type 2NCT00138593Novartis180
终止
1 期
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female VolunteersMetabolism and Nutrition DisorderObesityNCT00665665Novo Nordisk A/S101
已完成
3 期
A Study to Assess the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.Diabetes Mellitus, Type 2NCT00380380Novartis18
已完成
1 期
Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With ObesityMetabolism and Nutrition DisorderObesityNCT03095807Novo Nordisk A/S34