NCT00174720已完成3 期
A Multinational,Multicenter,Randomized,Double-Blind,Placebo-Controlled,Parallel-Group Study to Assess the Efficacy of Ciclesonide Metered-Dose Inhaler at a Daily Dose of 160 μg Administered Either in a Once-Daily in the Morning Regimen (160 μg qd AM) for 16 Weeks or in a 160 μg qd AM Regimen for 12 Weeks Preceded by a Twice-Daily Regimen (80 μg Bid) for 4 Weeks,or in an 80 μg Bid Regimen for 16 Weeks,in Adults and Adolescents With Mild to Moderate Persistent Asthma Not Treated With Steroids
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 708
- 试验地点
- 11
- 主要终点
- Change from baseline to Week 16 in FEV1
研究概览
简要总结
To investigate the efficacy of ciclesonide MDI either as once daily or twice daily in patients with mild to moderate asthma, who have not previously been treated with an inhaled corticosteroid.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 12 years or older
- •History of persistent bronchial asthma for at least 6 months
- •Documented use of bronchodilators (short acting only) only or methylxanthines for at least 1 month before screening
- •At screening, FEV1 60 to 90% of predicted. Reversibility of FEV1 by at least 12% post-bronchodilator
- •Be able to use oral inhalers
- •Non-smokers
排除标准
- •History of life-threatening asthma
- •Other pulmonary diseases
- •URI within 4 weeks before screening
- •Use of systemic steroids within 6 months before screening. Use of inhaled steroids within 30 days before screening. More than 2 in-patient hospitalizations or ER visits due to asthma exacerbations in the prior year before screening
- •Pregnant or breast-feeding females
- •Females of child-bearing potential not using adequate means of birth control
- •Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease
- •Abnormal clinical laboratory parameters that would limit participation in the study or interfere with interpretation of study results
- •History of drug or alcohol abuse
- •Treatment with any investigational product within 30 days prior to study entry
结局指标
主要结局
Change from baseline to Week 16 in FEV1
次要结局
- Symptom scores, rescue albuterol use and morning peak flow measurements
研究者
研究点 (11)
Loading locations...
相似试验
已完成
3 期
Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled CorticosteroidAsthmaNCT00174733Sanofi456
已完成
3 期
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.AsthmaNCT00392288AstraZeneca528
已完成
3 期
Effects Of Ciclesonide And Beclomethasone On Lens Opacification In Adult Subjects With Moderate To Severe Persistent AsthmaRespiratory Tract DiseasesRespiratory HypersensitivityAsthmaNCT00254956Sanofi1,568
已完成
2 期
A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With PlaceboAsthmaNCT01136382AstraZeneca304
进行中（未招募）
不适用
Comparison of Ciclesonide (80 µg Once Daily in the Evening) and Fluticasone propionate (100 µg Twice Daily) in Patients with Mild to Moderate AsthmaMedDRA version: 5.1Level: lltClassification code 10003553bronchial asthmaEUCTR2004-001072-39-DEALTANA Pharma AG480