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

NCT ID: NCT00118690

Last Updated: 2016-09-23

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2005-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchospasm Activity/Exercise Induced Bronchospasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluticasone propionate/salmeterol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Jonesboro, Arkansas, United States

Site Status

GSK Investigational Site

East Artesia, California, United States

Site Status

GSK Investigational Site

Huntington Beach, California, United States

Site Status

GSK Investigational Site

Long Beach, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Madera, California, United States

Site Status

GSK Investigational Site

Mission Viejo, California, United States

Site Status

GSK Investigational Site

Oakland, California, United States

Site Status

GSK Investigational Site

Rolling Hills Est, California, United States

Site Status

GSK Investigational Site

Vista, California, United States

Site Status

GSK Investigational Site

Denver, Colorado, United States

Site Status

GSK Investigational Site

Englewood, Colorado, United States

Site Status

GSK Investigational Site

Pueblo, Colorado, United States

Site Status

GSK Investigational Site

Altamonte Springs, Florida, United States

Site Status

GSK Investigational Site

Delray Beach, Florida, United States

Site Status

GSK Investigational Site

St. Petersburg, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Lawrenceville, Georgia, United States

Site Status

GSK Investigational Site

Marietta, Georgia, United States

Site Status

GSK Investigational Site

Savannah, Georgia, United States

Site Status

GSK Investigational Site

Savannah, Georgia, United States

Site Status

GSK Investigational Site

Normal, Illinois, United States

Site Status

GSK Investigational Site

Iowa City, Iowa, United States

Site Status

GSK Investigational Site

Louisville, Kentucky, United States

Site Status

GSK Investigational Site

Sunset, Louisiana, United States

Site Status

GSK Investigational Site

Bethesda, Maryland, United States

Site Status

GSK Investigational Site

Boston, Massachusetts, United States

Site Status

GSK Investigational Site

Robbinsdale, Minnesota, United States

Site Status

GSK Investigational Site

Missoula, Montana, United States

Site Status

GSK Investigational Site

Omaha, Nebraska, United States

Site Status

GSK Investigational Site

Mount Laurel, New Jersey, United States

Site Status

GSK Investigational Site

Kernersville, North Carolina, United States

Site Status

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

GSK Investigational Site

Medford, Oregon, United States

Site Status

GSK Investigational Site

Altoona, Pennsylvania, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Upland, Pennsylvania, United States

Site Status

GSK Investigational Site

Charleston, South Carolina, United States

Site Status

GSK Investigational Site

Mt. Pleasant, South Carolina, United States

Site Status

GSK Investigational Site

Orangeburg, South Carolina, United States

Site Status

GSK Investigational Site

Nashville, Tennessee, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

El Paso, Texas, United States

Site Status

GSK Investigational Site

El Paso, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Layton, Utah, United States

Site Status

GSK Investigational Site

Provo, Utah, United States

Site Status

GSK Investigational Site

South Burlington, Vermont, United States

Site Status

GSK Investigational Site

Burke, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Clinical Study Report

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

View Document

Document Type: Study Protocol

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

View Document

Document Type: Dataset Specification

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

View Document

Document Type: Individual Participant Data Set

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

View Document

Document Type: Informed Consent Form

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

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://www.findclinicalstudy.com

http://www.findclinicalstudy.com

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SFA100316

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Advair Pediatric Once-Daily
NCT00920959 COMPLETED PHASE3
Dose-Response of Salmeterol in Children
NCT01907334 COMPLETED PHASE4