Study Of Allergic Rhinitis In Patients Who Also Have Asthma

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: fluticasone propionate/salmeterol (FSC); Drug: fluticasone propionate (FP); Drug: placebo nasal; Drug: montelukast (MON); Drug: placebo DISKUS; Drug: ADVAIR DISKUS; Drug: placebo capsule

• Registration Number: NCT00296491
• Lead Sponsor: GlaxoSmithKline

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-02-23
• Study First Submitted QC: 2006-02-23
• Study First Posted: 2006-02-27
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Results First Submitted: 2008-10-31
• Results First Submitted QC: 2009-03-26
• Results First Posted: 2009-05-13
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 725

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)	fluticasone propionate/salmeterol (FSC)	Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)	fluticasone propionate (FP)	Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD
Fluticasone Propionate/Salmeterol (FSC)	fluticasone propionate/salmeterol (FSC)	FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)	ADVAIR DISKUS	Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)	ADVAIR DISKUS	Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD
Montelukast (MON)	placebo nasal	Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)	montelukast (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
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)	fluticasone propionate/salmeterol (FSC)	Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD
Fluticasone Propionate/Salmeterol (FSC)	ADVAIR DISKUS	FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
Fluticasone Propionate/Salmeterol (FSC)	placebo nasal	FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)	placebo capsule	Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD
Montelukast (MON)	placebo DISKUS	Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD
Fluticasone Propionate/Salmeterol (FSC)	placebo capsule	FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)	placebo nasal	Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD
Montelukast (MON)	montelukast (MON)	Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population	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	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 Outcome Measures

Name	Time	Method
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 symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied
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)	Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8.
Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population	Baseline to Endpoint (weeks 3-4)	Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).
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)	Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.
Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population	Baseline to Endpoint (weeks 3-4)	Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.
Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).	Baseline to 1-2 Weeks	The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate)
Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)	Baseline To 1-2 Weeks	The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time.
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)	Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇱 Lodz, Poland