EUCTR2007-002587-99-IT进行中（未招募）不适用
A 24-week, multicenter, multinational, randomized, double-blind, triple-dummy, 3-arm parallel group study comparing the efficacy and safety of CHF 1535 200/6 (beclomethasone dipropionate 200 g plus formoterol 6 g/actuation), 2 puffs b.i.d., versus beclomethasone diproprionate HFA (250 g/actuation), 4 puffs b.i.d., versus Seretide 500/50 (fluticasone 500 g plus salmeterol 50 g/actuation), 1 inhalation b.i.d., in patients with severe asthm - CCD-0605-PR-0021
CHIESI0 个研究点目标入组 1,050 人开始时间: 2008年1月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,050
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
- •1. Subject?s written informed consent and written informed consent by parents/legal representatives (adolescent patients). 2. Outpatients of both sexes aged 12 and 70 years. 3. Evidence of asthma demonstrated by a documented positive response to the reversibility test, defined as ΔFEV1 > 12% and > 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI. In case this is not achieved, a historically documented FEV1 reversibility within the previous 12 months is acceptable. 4. Patients with severe persistent asthma diagnosed according to GINA guidelines (revised 2006).
- •Are the trial subjects under 18? yes
- •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
- •Patient will not be enrolled at Visit 1 into the run-in period and will not be randomized to treatment at Visit 2 (i.e. these criteria will be also reviewed at Visit 2) if they meet one or more of the following criteria: 1. Pregnant or lactating women. Females of childbearing potential without an efficient contraception (e.g. oestro-progestatives, condoms). 2. Having received an investigational drug within 2 months. 3. Inability to comply with study procedures or with study treatment intake. 4. Seasonal asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer. 5. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease.
研究者
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