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
Overview
- Phase
- Phase 4
- Intervention
- placebo capsule
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 725
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Fluticasone Propionate/Salmeterol (FSC)
FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
Intervention: placebo capsule
Fluticasone Propionate/Salmeterol (FSC)
FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
Intervention: placebo nasal
Fluticasone Propionate/Salmeterol (FSC)
FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
Intervention: ADVAIR DISKUS
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
Intervention: fluticasone propionate/salmeterol (FSC)
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
Intervention: montelukast (MON)
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
Intervention: placebo nasal
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
Intervention: ADVAIR DISKUS
Fluticasone Propionate/Salmeterol (FSC)
FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
Intervention: fluticasone propionate/salmeterol (FSC)
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
Intervention: fluticasone propionate/salmeterol (FSC)
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
Intervention: fluticasone propionate (FP)
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
Intervention: ADVAIR DISKUS
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
Intervention: placebo capsule
Montelukast (MON)
Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD
Intervention: montelukast (MON)
Montelukast (MON)
Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD
Intervention: placebo nasal
Montelukast (MON)
Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD
Intervention: placebo DISKUS
Outcomes
Primary Outcomes
Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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))