Advair Pediatric Once-Daily

September 13, 2016 updated by: GlaxoSmithKline

A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma

To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

908

Phase

  • Phase 3

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

  • Argentina
      • Buenos Aires, Argentina, 1425
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, 1425
        • GSK Investigational Site
      • Santa Fe, Argentina, 3000
        • GSK Investigational Site
  • Chile
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile
        • GSK Investigational Site
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile
        • GSK Investigational Site
  • Peru
      • Breña, Peru, Lima 5
        • GSK Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • GSK Investigational Site
      • San Juan, Puerto Rico, 00935
        • GSK Investigational Site
  • United States
    • Alabama
      • Ozark, Alabama, United States, 36360
        • GSK Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85716
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85746
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Beverly Hills, California, United States, 90212
        • GSK Investigational Site
      • Crescent City, California, United States, 95531
        • GSK Investigational Site
      • Dinuba, California, United States, 93618
        • GSK Investigational Site
      • Fresno, California, United States, 93720
        • GSK Investigational Site
      • Huntington Beach, California, United States, 92647
        • GSK Investigational Site
      • La Jolla, California, United States, 92093
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Mission Viejo, California, United States, 92691
        • GSK Investigational Site
      • Newport Beach, California, United States, 92660
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Palmdale, California, United States, 93551
        • GSK Investigational Site
      • Panorama City, California, United States, 91402
        • GSK Investigational Site
      • Paramount, California, United States, 90723
        • GSK Investigational Site
      • Riverside, California, United States, 92506
        • GSK Investigational Site
      • Rolling Hills Estates, California, United States, 90274
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
      • San Francisco, California, United States, 94102
        • GSK Investigational Site
      • San Jose, California, United States, 95117
        • GSK Investigational Site
      • Sherman Oaks, California, United States, 91403
        • GSK Investigational Site
      • Vista, California, United States, 92083
        • GSK Investigational Site
      • Vista, California, United States, 92084
        • GSK Investigational Site
      • Walnut Creek, California, United States, 94598
        • GSK Investigational Site
    • Colorado
      • Centennial, Colorado, United States, 80112
        • GSK Investigational Site
      • 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
      • Denver, Colorado, United States, 80218
        • GSK Investigational Site
      • Pueblo, Colorado, United States, 81008
        • GSK Investigational Site
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • GSK Investigational Site
      • Hialeah, Florida, United States, 33013
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32216
        • GSK Investigational Site
      • Orlando, Florida, United States, 32806
        • GSK Investigational Site
      • Orlando, Florida, United States, 32801
        • GSK Investigational Site
      • Sarasota, Florida, United States, 34233
        • GSK Investigational Site
      • St. Petersburg, Florida, United States, 33710
        • GSK Investigational Site
      • Tallahassee, Florida, United States, 32308
        • GSK Investigational Site
      • Tampa, Florida, United States, 33613
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309-7520
        • GSK Investigational Site
      • Augusta, Georgia, United States, 30901
        • GSK Investigational Site
      • Barnesville, Georgia, United States, 30204
        • GSK Investigational Site
      • Martinez, Georgia, United States, 30907
        • GSK Investigational Site
      • Savannah, Georgia, United States, 31406
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • GSK Investigational Site
      • Glenview, Illinois, United States, 60025
        • GSK Investigational Site
      • Hoffman Estates, Illinois, United States, 60195
        • GSK Investigational Site
      • Park Ridge, Illinois, United States, 60068
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46208
        • GSK Investigational Site
      • South Bend, Indiana, United States, 46617
        • GSK Investigational Site
    • Kansas
      • Lawrence, Kansas, United States, 66047
        • GSK Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40222
        • GSK Investigational Site
      • Murray, Kentucky, United States, 42071
        • GSK Investigational Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • GSK Investigational Site
      • Metairie, Louisiana, United States, 70006
        • GSK Investigational Site
      • Metairie, Louisiana, United States, 70001
        • GSK Investigational Site
      • Shreveport, Louisiana, United States, 71104
        • GSK Investigational Site
      • Sunset, Louisiana, United States, 70584
        • GSK Investigational Site
    • Massachusetts
      • Newton, Massachusetts, United States, 02462
        • GSK Investigational Site
      • North Dartmouth, Massachusetts, United States, 02747
        • GSK Investigational Site
      • Taunton, Massachusetts, United States, 02780
        • GSK Investigational Site
      • West Quincy, Massachusetts, United States, 02169
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • GSK Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • GSK Investigational Site
      • Kansas City, Missouri, United States, 64108
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63108
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63139
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, United States, 59804
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68134
        • GSK Investigational Site
      • Papillion, Nebraska, United States, 68046
        • GSK Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • GSK Investigational Site
      • Brick, New Jersey, United States, 8724
        • GSK Investigational Site
      • East Orange, New Jersey, United States, 7017
        • GSK Investigational Site
      • Ocean, New Jersey, United States, 07712
        • GSK Investigational Site
      • Verona, New Jersey, United States, 7044
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • GSK Investigational Site
    • New York
      • Buffalo, New York, United States, 14222
        • GSK Investigational Site
      • Liverpool, New York, United States, 13088
        • GSK Investigational Site
      • New Hyde Park, New York, United States, 11042
        • GSK Investigational Site
      • Rockville Center, New York, United States, 11570
        • GSK Investigational Site
      • Vestal, New York, United States, 13850
        • GSK Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28204
        • GSK Investigational Site
      • Durham, North Carolina, United States, 27704
        • GSK Investigational Site
      • Elizabeth City, North Carolina, United States, 27909
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45231
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44106
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • GSK Investigational Site
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
      • Portland, Oregon, United States, 97213
        • GSK Investigational Site
      • Portland, Oregon, United States, 97223
        • GSK Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • GSK Investigational Site
      • Blue Belle, Pennsylvania, United States, 19422
        • GSK Investigational Site
      • Harrisburg, Pennsylvania, United States, 17110
        • GSK Investigational Site
      • Lewisburg, Pennsylvania, United States, 17837
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19135
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15202
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • GSK Investigational Site
      • Upland, Pennsylvania, United States, 19013
        • GSK Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865-4208
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • GSK Investigational Site
      • Greenville, South Carolina, United States, 29607
        • GSK Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • GSK Investigational Site
      • Knoxville, Tennessee, United States, 37922
        • GSK Investigational Site
      • Knoxville, Tennessee, United States, 37917
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78749
        • GSK Investigational Site
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
      • El Paso, Texas, United States, 79925
        • GSK Investigational Site
      • El Paso, Texas, United States, 79902
        • GSK Investigational Site
      • Galveston, Texas, United States, 77555-0188
        • GSK Investigational Site
      • Houston, Texas, United States, 77074
        • GSK Investigational Site
      • Houston, Texas, United States, 77054
        • GSK Investigational Site
      • Houston, Texas, United States, 77065
        • GSK Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • GSK Investigational Site
      • New Braunfels, Texas, United States, 78130
        • GSK Investigational Site
      • Plano, Texas, United States, 75093
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78205
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78233
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78207
        • GSK Investigational Site
    • Utah
      • Layton, Utah, United States, 84041
        • GSK Investigational Site
      • Murray, Utah, United States, 84107
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, United States, 22015
        • GSK Investigational Site
      • Norfolk, Virginia, United States, 23510
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23298
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23229
        • GSK Investigational Site
    • Washington
      • Edmonds, Washington, United States, 98026
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • GSK Investigational Site
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • GSK Investigational Site
      • La Crosse, Wisconsin, United States, 54601
        • 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

4 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Out-patients
  • Asthma diagnosis
  • Reversibility
  • Short-acting beta-agonist or asthma controlled medication use

Exclusion Criteria:

  • Life-threatening asthma
  • Specified asthma medications
  • Chickenpox
  • Drug allergy
  • Respiratory infections
  • Tobacco use
  • Clinical laboratory abnormalities
  • Ophthalmologic conditions
  • Investigation medications
  • Affiliation with investigator site

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluticasone propionate/salmeterol combination
study drug
Drug: FSC 100/50mcg
Once-daily dosing
Experimental: Fluticasone propionate
study drug
Drug: FP 100mcg
Once-daily dosing
Experimental: Placebo
placebo
Drug: Placebo
Once-daily dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline at endpoint in daily PM PEF
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Various pulmonary function endpoints
Time Frame: 12 weeks
12 weeks

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.

Helpful Links

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

November 1, 2001

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

June 12, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (Estimate)

June 15, 2009

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAS30021

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

  1. Informed Consent Form
    Information identifier: SAS30021
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: SAS30021
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: SAS30021
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: SAS30021
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: SAS30021
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: SAS30021
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Clinical Study Report
    Information identifier: SAS30021
    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.

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