Control of Moderate or Severe Asthma With 160, 320 and 640 mcg Ciclesonide/Day. A One-year Randomised, Double-blind, Multicenter Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 520
- 主要终点
- Change From Baseline in ACQ Score to Tlast
研究概览
简要总结
The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).
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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent was provided
- •History of persistent bronchial asthma for at least 6 months
- •Current treatment with an Inhaled Corticosteroid (ICS) at a stable dose in the dose range of 200-1000 μg Fluticasone Propionate (FP)/day or equivalent for a minimum of 12 weeks
- •Good inhalation technique
- •Under the current ICS pre-treatment the ACQ score ranges between ≥ 0.75 and ≥ 2
排除标准
- •Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
- •Concomitant severe diseases (e.g. malignant diseases during the past 5 years [other than basal or squamous cell carcinoma], hepatitis C, acquired immune deficiency syndrome [AIDS])
- •Diseases which are contraindications for the use of ICS (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
- •Use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
研究组 & 干预措施
CIC 640
Two puffs of 160 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 640 mcg)
干预措施: Ciclesonide (Drug)
CIC 160
Two puffs of 40 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 160 mcg)
干预措施: Ciclesonide (Drug)
CIC 320
Two puffs of 80 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 320 mcg)
干预措施: Ciclesonide (Drug)
结局指标
主要结局
Change From Baseline in ACQ Score to Tlast
时间窗: Week 52
The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
Asthma Control Questionnaire (ACQ) Score at Baseline
时间窗: Baseline
The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
次要结局
- Time Course of ACQ(Baseline, Week 52 (Treatment period))
- Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement(Baseline up to Week 52 (treatment period))
- Number of Weeks With Well-controlled Asthma Over the Course of the Study(Baseline up to Week 52 (treatment period))
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)(Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56))
- Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings(Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56))
- Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs(Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56))
- Number of Participants With Markedly Abnormal Laboratory Values(Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56))
- Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study(Week 52)
- Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point(Baseline up to Week 52 (treatment period))
- Number of Participants With Markedly High Benefits(Week 1 up to Week 52)
- Number of Participants Reporting Time to First Asthma Exacerbation(Baseline up to Week 52 (treatment period))
- Number of Participants Reporting Asthma Exacerbations Rates(Baseline up to Week 52 (treatment period))