A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise

September 22, 2016 updated by: GlaxoSmithKline

A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm

During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

227

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
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • GSK Investigational Site
    • California
      • East Artesia, California, United States, 90706
        • GSK Investigational Site
      • Huntington Beach, California, United States, 92647
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Los Angeles, California, United States, 90015
        • GSK Investigational Site
      • Madera, California, United States, 93638
        • GSK Investigational Site
      • Mission Viejo, California, United States, 92691
        • GSK Investigational Site
      • Oakland, California, United States, 94618
        • GSK Investigational Site
      • Rolling Hills Est, California, United States, 90274
        • GSK Investigational Site
      • Vista, California, United States, 92083
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • GSK Investigational Site
      • Englewood, Colorado, United States, 80112
        • GSK Investigational Site
      • Pueblo, Colorado, United States, 81008
        • GSK Investigational Site
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • GSK Investigational Site
      • Delray Beach, Florida, United States, 33484
        • GSK Investigational Site
      • St. Petersburg, Florida, United States, 33710
        • GSK Investigational Site
      • Tampa, Florida, United States, 33613
        • GSK Investigational Site
      • Tampa, Florida, United States, 33607
        • GSK Investigational Site
    • Georgia
      • Lawrenceville, Georgia, United States, 30045
        • GSK Investigational Site
      • Marietta, Georgia, United States, 30062
        • GSK Investigational Site
      • Savannah, Georgia, United States, 31419
        • GSK Investigational Site
      • Savannah, Georgia, United States, 31406
        • GSK Investigational Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • GSK Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • GSK Investigational Site
    • Louisiana
      • Sunset, Louisiana, United States, 70584
        • GSK Investigational Site
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • GSK Investigational Site
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, United States, 59804
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • GSK Investigational Site
    • New Jersey
      • Mount Laurel, New Jersey, United States, 08054
        • GSK Investigational Site
    • North Carolina
      • Kernersville, North Carolina, United States, 27284
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • GSK Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • GSK Investigational Site
      • Upland, Pennsylvania, United States, 19013
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • GSK Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • GSK Investigational Site
      • Orangeburg, South Carolina, United States, 29118
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203-1424
        • GSK Investigational Site
    • Texas
      • 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
      • Houston, Texas, United States, 77054
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78205
        • GSK Investigational Site
    • Utah
      • Layton, Utah, United States, 84041
        • GSK Investigational Site
      • Provo, Utah, United States, 84604
        • GSK Investigational Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, United States, 22015
        • 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 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Diagnosed with persistent asthma for 3 months or longer.
  • Experience worsened asthma symptoms during physical activity.
  • Using or used an inhaled steroid for the last 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, or Vanceril).

Exclusion criteria:

  • Used systemic steroids as either liquids, pills, or injections to treat asthma within the last 3 months.
  • Have only intermittent, seasonal, or exercise induced asthma, and not persistent asthma.
  • Admitted to a hospital within the last 6 months due to asthma symptoms.
  • Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.).
  • The study physician will evaluate other medical 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
Change in maximal decline from baseline in lung function following exercise challenge after 4-weeks of double-blind treatment compared to decline in lung function before treatment.

Secondary Outcome Measures

Outcome Measure
Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

December 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

July 1, 2005

First Submitted That Met QC Criteria

July 1, 2005

First Posted (Estimate)

July 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFA100316

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. Clinical Study Report
    Information identifier: SFA100316
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: SFA100316
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: SFA100316
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: SFA100316
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: SFA100316
    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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