A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who Are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 725
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population
研究概览
简要总结
This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.
详细描述
A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fluticasone Propionate/Salmeterol (FSC)
FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
干预措施: placebo capsule (Drug)
Fluticasone Propionate/Salmeterol (FSC)
FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
干预措施: placebo nasal (Drug)
Fluticasone Propionate/Salmeterol (FSC)
FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
干预措施: ADVAIR DISKUS (Drug)
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)
Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD
干预措施: fluticasone propionate/salmeterol (FSC) (Drug)
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)
Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD
干预措施: montelukast (MON) (Drug)
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)
Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD
干预措施: placebo nasal (Drug)
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)
Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD
干预措施: ADVAIR DISKUS (Drug)
Fluticasone Propionate/Salmeterol (FSC)
FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
干预措施: fluticasone propionate/salmeterol (FSC) (Drug)
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)
Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD
干预措施: fluticasone propionate/salmeterol (FSC) (Drug)
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)
Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD
干预措施: fluticasone propionate (FP) (Drug)
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)
Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD
干预措施: ADVAIR DISKUS (Drug)
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)
Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD
干预措施: placebo capsule (Drug)
Montelukast (MON)
Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD
干预措施: montelukast (MON) (Drug)
Montelukast (MON)
Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD
干预措施: placebo nasal (Drug)
Montelukast (MON)
Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD
干预措施: placebo DISKUS (Drug)
结局指标
主要结局
Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population
时间窗: Baseline to Endpoint (weeks 3-4)
Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.
Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population
时间窗: Baseline to Endpoint (weeks 3-4)
Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.
次要结局
- Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population(Baseline to Endpoint (weeks 3-4))
- Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population(Baseline to Endpoint (weeks 3-4))
- Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population(Baseline to Endpoint (weeks 3-4))
- Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population(Baseline to Endpoint (weeks 3-4))
- Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population(Baseline to Endpoint (weeks 3-4))
- Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).(Baseline to 1-2 Weeks)
- Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)(Baseline To 1-2 Weeks)
- Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population(Baseline to Endpoint (weeks 3-4))