A Multicenter, Randomized, Placebo-Controlled, Double-Blind, 2-Period, Parallel-Group Study to Assess the Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 642
- 主要终点
- Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma
研究概览
简要总结
This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone 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
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female patients tested negative for pregnancy and agreed to use appropriate contraceptives through out the study
- •Patient was a nonsmoker
- •Patient was in good general health (except for asthma)
排除标准
- •Patient was hospitalized
- •Patient was female who was less than 8 weeks postpartum or breast feeding
- •Patient planned to move or vacation away during the study
- •Patient had major surgery within 4 weeks the past 4 weeks
- •Patient has donated blood or participated in a clinical trial within the past 4 weeks
- •Patient was a regular user or recent abuser of alcohol or illicit drugs
- •Patient was 40% over or under normal weight for height
研究组 & 干预措施
1
Montelukast + Beclomethasone
干预措施: montelukast sodium (Drug)
1
Montelukast + Beclomethasone
干预措施: beclomethasone (Drug)
2
Montelukast + Placebo inhaler
干预措施: montelukast sodium (Drug)
2
Montelukast + Placebo inhaler
干预措施: Placebo inhaler (Drug)
3
Placebo tablet + Beclomethasone
干预措施: beclomethasone (Drug)
3
Placebo tablet + Beclomethasone
干预措施: placebo tablet (Drug)
4
Placebo tablet + Placebo inhaler
干预措施: Placebo inhaler (Drug)
4
Placebo tablet + Placebo inhaler
干预措施: placebo tablet (Drug)
结局指标
主要结局
Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma
时间窗: Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups
Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups
Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma
时间窗: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms \[from 0 (best) to 6 (worst)\] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary. The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits.
次要结局
- Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use(Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups)
- Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only(Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups)
- Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma(Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups)