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Study Of Patients With Allergic Rhinitis And Asthma

NCT ID: NCT00296530

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-07-31

Brief Summary

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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

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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

Conditions

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Asthma

Keywords

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Asthma Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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fluticasone propionate/salmeterol

Intervention Type DRUG

fluticasone propionate

Intervention Type DRUG

montelukast

Intervention Type DRUG

Other Intervention Names

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fluticasone propionate/salmeterol fluticasone propionate

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Ozark, Alabama, United States

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Tempe, Arizona, United States

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Little Rock, Arkansas, United States

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Fountain Valley, California, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Palmdale, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Jose, California, United States

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Stockton, California, United States

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Vista, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Wheat Ridge, Colorado, United States

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Coral Gables, Florida, United States

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Miami, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Lawrenceville, Georgia, United States

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Lilburn, Georgia, United States

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Marietta, Georgia, United States

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Kenilworth, Illinois, United States

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Iowa City, Iowa, United States

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Covington, Louisiana, United States

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Lafayette, Louisiana, United States

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Metairie, Louisiana, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Chevy Chase, Maryland, United States

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North Andover, Massachusetts, United States

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Ypsilanti, Michigan, United States

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Rolla, Missouri, United States

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Omaha, Nebraska, United States

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Ocean City, New Jersey, United States

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Skillman, New Jersey, United States

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Ithaca, New York, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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North Olmsted, Ohio, United States

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Sylvania, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Collegeville, Pennsylvania, United States

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Gibsonia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Killeen, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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Murray, Utah, United States

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West Jordan, Utah, United States

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South Burlington, Vermont, United States

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Charlottesville, Virginia, United States

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Countries

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United States

References

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This study has not been published in the scientific literature.

Reference Type BACKGROUND

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.

Reference Type DERIVED
PMID: 20167147 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Document Type: Clinical Study Report

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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ADA103578

Identifier Type: -

Identifier Source: org_study_id