NCT00920959

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
908

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Nov 2001

Typical duration for phase_3 asthma

Geographic Reach
5 countries

149 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

2.2 years

First QC Date

June 12, 2009

Last Update Submit

September 13, 2016

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change from baseline at endpoint in daily PM PEF

    12 weeks

Secondary Outcomes (1)

  • Various pulmonary function endpoints

    12 weeks

Study Arms (3)

Fluticasone propionate/salmeterol combination

EXPERIMENTAL

study drug

Drug: FSC 100/50mcg

Fluticasone propionate

EXPERIMENTAL

study drug

Drug: FP 100mcg

Placebo

EXPERIMENTAL

placebo

Drug: Placebo

Interventions

FP 100mcgDRUG

Once-daily dosing

Fluticasone propionate
FSC 100/50mcgDRUG

Once-daily dosing

Fluticasone propionate/salmeterol combination
PlaceboDRUG

Once-daily dosing

Placebo

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (149)

GSK Investigational Site

Ozark, Alabama, 36360, United States

Location

GSK Investigational Site

Tucson, Arizona, 85716, United States

Location

GSK Investigational Site

Tucson, Arizona, 85746, United States

Location

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Beverly Hills, California, 90212, United States

Location

GSK Investigational Site

Crescent City, California, 95531, United States

Location

GSK Investigational Site

Dinuba, California, 93618, United States

Location

GSK Investigational Site

Fresno, California, 93720, United States

Location

GSK Investigational Site

Huntington Beach, California, 92647, United States

Location

GSK Investigational Site

La Jolla, California, 92093, United States

Location

GSK Investigational Site

Long Beach, California, 90806, United States

Location

GSK Investigational Site

Mission Viejo, California, 92691, United States

Location

GSK Investigational Site

Newport Beach, California, 92660, United States

Location

GSK Investigational Site

Orange, California, 92868, United States

Location

GSK Investigational Site

Palmdale, California, 93551, United States

Location

GSK Investigational Site

Panorama City, California, 91402, United States

Location

GSK Investigational Site

Paramount, California, 90723, United States

Location

GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

Rolling Hills Estates, California, 90274, United States

Location

GSK Investigational Site

San Diego, California, 92120, United States

Location

GSK Investigational Site

San Francisco, California, 94102, United States

Location

GSK Investigational Site

San Jose, California, 95117, United States

Location

GSK Investigational Site

Sherman Oaks, California, 91403, United States

Location

GSK Investigational Site

Vista, California, 92083, United States

Location

GSK Investigational Site

Vista, California, 92084, United States

Location

GSK Investigational Site

Walnut Creek, California, 94598, United States

Location

GSK Investigational Site

Centennial, Colorado, 80112, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80907, United States

Location

GSK Investigational Site

Denver, Colorado, 80206, United States

Location

GSK Investigational Site

Denver, Colorado, 80218, United States

Location

GSK Investigational Site

Denver, Colorado, 80230, United States

Location

GSK Investigational Site

Pueblo, Colorado, 81008, United States

Location

GSK Investigational Site

Altamonte Springs, Florida, 32701, United States

Location

GSK Investigational Site

Hialeah, Florida, 33013, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32216, United States

Location

GSK Investigational Site

Orlando, Florida, 32801, United States

Location

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Sarasota, Florida, 34233, United States

Location

GSK Investigational Site

St. Petersburg, Florida, 33710, United States

Location

GSK Investigational Site

Tallahassee, Florida, 32308, United States

Location

GSK Investigational Site

Tampa, Florida, 33613, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30309-7520, United States

Location

GSK Investigational Site

Augusta, Georgia, 30901, United States

Location

GSK Investigational Site

Barnesville, Georgia, 30204, United States

Location

GSK Investigational Site

Martinez, Georgia, 30907, United States

Location

GSK Investigational Site

Savannah, Georgia, 31406, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Glenview, Illinois, 60025, United States

Location

GSK Investigational Site

Hoffman Estates, Illinois, 60195, United States

Location

GSK Investigational Site

Park Ridge, Illinois, 60068, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46208, United States

Location

GSK Investigational Site

South Bend, Indiana, 46617, United States

Location

GSK Investigational Site

Lawrence, Kansas, 66047, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40222, United States

Location

GSK Investigational Site

Murray, Kentucky, 42071, United States

Location

GSK Investigational Site

Covington, Louisiana, 70433, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70001, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71104, United States

Location

GSK Investigational Site

Sunset, Louisiana, 70584, United States

Location

GSK Investigational Site

Newton, Massachusetts, 02462, United States

Location

GSK Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

GSK Investigational Site

Taunton, Massachusetts, 02780, United States

Location

GSK Investigational Site

West Quincy, Massachusetts, 02169, United States

Location

GSK Investigational Site

Detroit, Michigan, 48202, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55416, United States

Location

GSK Investigational Site

Columbia, Missouri, 65212, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64108, United States

Location

GSK Investigational Site

St Louis, Missouri, 63108, United States

Location

GSK Investigational Site

St Louis, Missouri, 63139, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

Missoula, Montana, 59804, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68130, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68134, United States

Location

GSK Investigational Site

Papillion, Nebraska, 68046, United States

Location

GSK Investigational Site

Berlin, New Jersey, 08009, United States

Location

GSK Investigational Site

Brick, New Jersey, 8724, United States

Location

GSK Investigational Site

East Orange, New Jersey, 7017, United States

Location

GSK Investigational Site

Ocean City, New Jersey, 07712, United States

Location

GSK Investigational Site

Verona, New Jersey, 7044, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87131, United States

Location

GSK Investigational Site

Buffalo, New York, 14222, United States

Location

GSK Investigational Site

Liverpool, New York, 13088, United States

Location

GSK Investigational Site

New Hyde Park, New York, 11042, United States

Location

GSK Investigational Site

Rockville Centre, New York, 11570, United States

Location

GSK Investigational Site

Vestal, New York, 13850, United States

Location

GSK Investigational Site

Asheville, North Carolina, 28801, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28204, United States

Location

GSK Investigational Site

Durham, North Carolina, 27704, United States

Location

GSK Investigational Site

Elizabeth City, North Carolina, 27909, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Canton, Ohio, 44718, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45231, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44106, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73120, United States

Location

GSK Investigational Site

Bend, Oregon, 97701, United States

Location

GSK Investigational Site

Medford, Oregon, 97504, United States

Location

GSK Investigational Site

Portland, Oregon, 97213, United States

Location

GSK Investigational Site

Portland, Oregon, 97223, United States

Location

GSK Investigational Site

Altoona, Pennsylvania, 16601, United States

Location

GSK Investigational Site

Blue Belle, Pennsylvania, 19422, United States

Location

GSK Investigational Site

Harrisburg, Pennsylvania, 17110, United States

Location

GSK Investigational Site

Lewisburg, Pennsylvania, 17837, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19135, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15202, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

Location

GSK Investigational Site

Upland, Pennsylvania, 19013, United States

Location

GSK Investigational Site

Lincoln, Rhode Island, 02865-4208, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29407, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29607, United States

Location

GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37916, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37917, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37922, United States

Location

GSK Investigational Site

Austin, Texas, 78749, United States

Location

GSK Investigational Site

Dallas, Texas, 75230, United States

Location

GSK Investigational Site

El Paso, Texas, 79902, United States

Location

GSK Investigational Site

El Paso, Texas, 79925, United States

Location

GSK Investigational Site

Galveston, Texas, 77555-0188, United States

Location

GSK Investigational Site

Houston, Texas, 77054, United States

Location

GSK Investigational Site

Houston, Texas, 77065, United States

Location

GSK Investigational Site

Houston, Texas, 77074, United States

Location

GSK Investigational Site

Lake Jackson, Texas, 77566, United States

Location

GSK Investigational Site

New Braunfels, Texas, 78130, United States

Location

GSK Investigational Site

Plano, Texas, 75093, United States

Location

GSK Investigational Site

San Antonio, Texas, 78205, United States

Location

GSK Investigational Site

San Antonio, Texas, 78207, United States

Location

GSK Investigational Site

San Antonio, Texas, 78233, United States

Location

GSK Investigational Site

Layton, Utah, 84041, United States

Location

GSK Investigational Site

Murray, Utah, 84107, United States

Location

GSK Investigational Site

Burke, Virginia, 22015, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23510, United States

Location

GSK Investigational Site

Richmond, Virginia, 23229, United States

Location

GSK Investigational Site

Richmond, Virginia, 23298, United States

Location

GSK Investigational Site

Edmonds, Washington, 98026, United States

Location

GSK Investigational Site

Tacoma, Washington, 98405, United States

Location

GSK Investigational Site

Charleston, West Virginia, 25301, United States

Location

GSK Investigational Site

Greenfield, Wisconsin, 53228, United States

Location

GSK Investigational Site

La Crosse, Wisconsin, 54601, United States

Location

GSK Investigational Site

Buenos Aires, Buenos Aires, 1425, Argentina

Location

GSK Investigational Site

Santa Fe, Santa Fe Province, 3000, Argentina

Location

GSK Investigational Site

Buenos Aires, 1425, Argentina

Location

GSK Investigational Site

Viña del Mar, Región de Valparaíso, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Location

GSK Investigational Site

Breña, Lima 5, Peru

Location

GSK Investigational Site

Ponce, Puerto Rico, 00716, Puerto Rico

Location

GSK Investigational Site

San Juan, Puerto Rico, 00935, Puerto Rico

Location

Related Publications (1)

  • This study has not been published in the scientific literature.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 15, 2009

Study Start

November 1, 2001

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

September 15, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

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

Available IPD Datasets

Informed Consent Form (SAS30021)Access
Study Protocol (SAS30021)Access
Annotated Case Report Form (SAS30021)Access
Statistical Analysis Plan (SAS30021)Access
Dataset Specification (SAS30021)Access
Individual Participant Data Set (SAS30021)Access
Clinical Study Report (SAS30021)Access

Locations

AR(3)PE(1)PR(2)US(141)CL(2)