EUCTR2007-003189-16-IT进行中（未招募）不适用
A randomized, multi-center, parallel group, double blind, placebo and formoterol controlled 14 day dose ranging trial of 4 doses of indacaterol delivered via Twisthaler in patients with COPD - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 558
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
- •Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment ? see Section 6.6.5.5.) 2. Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and: a) Smoking history of at least 10 pack years b) Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value. c) Post-bronchodilator FEV1/FVC < 70% (Post refers to within 30 min of inhalation of 400/360 µg of salbutamol/albuterol MDI (or equivalent dose of DPI
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception. Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2. Patients with a history of asthma. Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study. Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.
研究者
相似试验
进行中（未招募）
1 期
A randomized, multi-center, parallel group, double-blind, placebo and formetrol controlled 14 day dose ranging trial of 4 doses of indacaterol delivered via Twisthaler®, in adult and adolescent patients with persistent asthmapersistent asthmaMedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2007-003191-19-SKovartis Pharma Services AG488
已完成
不适用
A randomized, multi-center, parallel group, double blind, study to assess the safety of QMF Twisthaler® (500/400µg) and mometasone furoate Twisthaler® (400µg) in adolescent and adult patients with persistent asthma.-J45J45PER-121-09OVARTIS BIOSCIENSES PERU S.A.,98
进行中（未招募）
不适用
A randomized, multi-center, parallel group, double-blind, placebo and formetrol controlled 14 day dose ranging trial of 4 doses of indacaterol delivered via Twisthaler®, in adult and adolescent patients with persistent asthmapersistent asthmaMedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2007-003191-19-HUovartis Pharma Services AG488
进行中（未招募）
不适用
A randomized, multi-center, parallel group, double blind, study to assess the safety of QMF Twisthaler® (500/400µg) and mometasone furoate Twisthaler® (400µg) in adolescent and adult patients with persistent asthma.EUCTR2009-011539-10-HUovartis Pharma Services AG1,500
进行中（未招募）
1 期
A randomized, multi-center, parallel group, double blind, study to assess the safety of QMF Twisthaler® (500/400µg) and mometasone furoate Twisthaler® (400µg) in adolescent and adult patients with persistent asthma.Persistent asthmaMedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2009-011539-10-SKovartis Pharma Services AG1,500