SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants in Each Arm With a Need for an Increase in Study Medication
研究概览
简要总结
An 18 months randomised double-blind study with two parallel arms with start dose of inhaled SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be up-titrated until well controlled is achieved, After 6 months the treatment continues without changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that the combination therapy with SERETIDE controls mild persistent asthma better than inhaled corticosteroids(FLIXOTIDE) alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to give informed consent.
- •Males or females aged 18-
- •Able to understand and complete dairy cards.
- •Mild persistent asthma according to GINA. In addition, at randomisation subjects were required to have:
- •Day time symptoms more than once a week but not every day.
- •Night-time symptoms not more than once a week.
- •FEV1 >80% predicted
- •PC20 <8mg/mL
排除标准
- •Change to regular asthma medication in 4-weeks prior to visit
- •Use of oral, depot or parenteral corticosteroids within 8 weeks of visit
- •Lower respiratory tract within 4 weeks of Visit 1
- •Received investigational study drug within 4 weeks of visit
- •Smoking history of >10 pack years of more.
- •Serious uncontrolled disease.
- •Medical conditions or medications known to affect the assessments or endpoints.
- •Evidence of alcohol or drug abuse.
- •Known pregnancy or planned pregnancy.
- •Known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
- •Previous enrollment in the study
研究组 & 干预措施
Seretide
Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
干预措施: Seretide (Drug)
Flixotide
Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
干预措施: Flixotide (Drug)
结局指标
主要结局
Number of Participants in Each Arm With a Need for an Increase in Study Medication
时间窗: Up to 18 months
During the first 6 months, when the asthma was unstable/uncontrolled, dose of Seretide (Sal/FP) was increased from 50/100 mcg in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). Also, dose of Flixotide (FP only), was increased from 100 mcg to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months. Number of participants in each arm with a need for an increase in study medication are presented.
次要结局
- Absolute Bronchial Hyper-responsiveness up to 18 Months(Up to 18 months)
- Change in Bronchial Hyper-responsiveness From Baseline to 18 Months(Baseline (Day 0) to 18 months)
- Number of Symptom-free Days and Nights Without Use of Rescue Medication(Up to 18 months)
- Number of Exacerbations: in Total and by Degree of Severity(Up to 18 months)
- Time to Increase of Study Medication(Up to 6 months)