Study Of Patients With Allergic Rhinitis And Asthma

October 27, 2016 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

600

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Ozark, Alabama, United States, 36360
    - GSK Investigational Site
- Arizona
  - Tempe, Arizona, United States, 85282
    - GSK Investigational Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - GSK Investigational Site
- California
  - Fountain Valley, California, United States, 92708
    - GSK Investigational Site
  - Huntington Beach, California, United States, 92647
    - GSK Investigational Site
  - Long Beach, California, United States, 90808
    - GSK Investigational Site
  - Los Angeles, California, United States, 90095-1752
    - GSK Investigational Site
  - Orange, California, United States, 92868
    - GSK Investigational Site
  - Palmdale, California, United States, 93551
    - GSK Investigational Site
  - Riverside, California, United States, 92506
    - GSK Investigational Site
  - San Diego, California, United States, 92123
    - GSK Investigational Site
  - San Jose, California, United States, 95128
    - GSK Investigational Site
  - Stockton, California, United States, 95207
    - GSK Investigational Site
  - Vista, California, United States, 92083
    - GSK Investigational Site
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - GSK Investigational Site
  - Denver, Colorado, United States, 80206
    - GSK Investigational Site
  - Denver, Colorado, United States, 80230
    - GSK Investigational Site
  - Wheat Ridge, Colorado, United States, 80033
    - GSK Investigational Site
- Florida
  - Coral Gables, Florida, United States, 33134
    - GSK Investigational Site
  - Miami, Florida, United States, 33176
    - GSK Investigational Site
  - Sarasota, Florida, United States, 34239
    - GSK Investigational Site
  - Tampa, Florida, United States, 33613
    - GSK Investigational Site
- Georgia
  - Lawrenceville, Georgia, United States, 30045
    - GSK Investigational Site
  - Lilburn, Georgia, United States, 30047
    - GSK Investigational Site
  - Marietta, Georgia, United States, 30060
    - GSK Investigational Site
- Illinois
  - Kenilworth, Illinois, United States, 60043
    - GSK Investigational Site
- Iowa
  - Iowa City, Iowa, United States, 52242
    - GSK Investigational Site
- Louisiana
  - Covington, Louisiana, United States, 70433
    - GSK Investigational Site
  - Lafayette, Louisiana, United States, 70503
    - GSK Investigational Site
  - Metairie, Louisiana, United States, 70006
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21236
    - GSK Investigational Site
  - Bethesda, Maryland, United States, 20814
    - GSK Investigational Site
  - Chevy Chase, Maryland, United States, 20815
    - GSK Investigational Site
- Massachusetts
  - North Andover, Massachusetts, United States, 01845
    - GSK Investigational Site
- Michigan
  - Ypsilanti, Michigan, United States, 48197
    - GSK Investigational Site
- Missouri
  - Rolla, Missouri, United States, 65401
    - GSK Investigational Site
- Nebraska
  - Omaha, Nebraska, United States, 68130
    - GSK Investigational Site
- New Jersey
  - Ocean, New Jersey, United States, 07712
    - GSK Investigational Site
  - Skillman, New Jersey, United States, 08558
    - GSK Investigational Site
- New York
  - Ithaca, New York, United States, 14850
    - GSK Investigational Site
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - GSK Investigational Site
- Ohio
  - Cincinnati, Ohio, United States, 45231
    - GSK Investigational Site
  - North Olmsted, Ohio, United States, 44070
    - GSK Investigational Site
  - Sylvania, Ohio, United States, 43560
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73104
    - GSK Investigational Site
- Oregon
  - Eugene, Oregon, United States, 97401
    - GSK Investigational Site
  - Lake Oswego, Oregon, United States, 97035
    - GSK Investigational Site
  - Medford, Oregon, United States, 97504
    - GSK Investigational Site
- Pennsylvania
  - Collegeville, Pennsylvania, United States, 19426
    - GSK Investigational Site
  - Gibsonia, Pennsylvania, United States, 15044
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19140
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19115
    - GSK Investigational Site
- Rhode Island
  - East Providence, Rhode Island, United States, 02914
    - GSK Investigational Site
  - Providence, Rhode Island, United States, 02906
    - GSK Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29406
    - GSK Investigational Site
  - Charleston, South Carolina, United States, 29414
    - GSK Investigational Site
  - Greer, South Carolina, United States, 29651
    - GSK Investigational Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - GSK Investigational Site
  - Germantown, Tennessee, United States, 38138
    - GSK Investigational Site
- Texas
  - Austin, Texas, United States, 78750
    - GSK Investigational Site
  - Austin, Texas, United States, 78704
    - GSK Investigational Site
  - Corsicana, Texas, United States, 75110
    - GSK Investigational Site
  - Dallas, Texas, United States, 75230
    - GSK Investigational Site
  - Dallas, Texas, United States, 75231
    - GSK Investigational Site
  - Dallas, Texas, United States, 75231-4307
    - GSK Investigational Site
  - El Paso, Texas, United States, 79925
    - GSK Investigational Site
  - El Paso, Texas, United States, 79902
    - GSK Investigational Site
  - Houston, Texas, United States, 77070
    - GSK Investigational Site
  - Houston, Texas, United States, 77054
    - GSK Investigational Site
  - Killeen, Texas, United States, 76542
    - GSK Investigational Site
  - Plano, Texas, United States, 75093
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78205
    - GSK Investigational Site
  - Waco, Texas, United States, 76712
    - GSK Investigational Site
- Utah
  - Murray, Utah, United States, 84107
    - GSK Investigational Site
  - West Jordan, Utah, United States, 84084
    - GSK Investigational Site
- Vermont
  - South Burlington, Vermont, United States, 05403
    - GSK Investigational Site
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Have asthma for at least 3 months prior to the study.
Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
Currently have seasonal allergic rhinitis and have had seasonal onset of allergic rhinitis for at least the two previous allergy seasons.
Have a positive allergy skin test.

Exclusion Criteria:

Have a history of life-threatening asthma.
Been hospitalized for asthma within the 6 months prior to the study.
Have certain conditions that would make study participation unsafe.

The study doctor will evaluate other inclusion and exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Morning Peak Expiratory Flow

Secondary Outcome Measures

Outcome Measure
Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

This study has not been published in the scientific literature.
Katial RK, Oppenheimer JJ, Ostrom NK, Mosnaim GS, Yancey SW, Waitkus-Edwards KR, Prillaman BA, Ortega HG. Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis. Allergy Asthma Proc. 2010 Jan-Feb;31(1):68-75. doi: 10.2500/aap.2010.31.3306.

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

ADA103578

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

Individual Participant Data Set
Information identifier: ADA103578

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: ADA103578

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: ADA103578

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: ADA103578

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: ADA103578

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: ADA103578

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: ADA103578

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.