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

NCT ID: NCT00118716

Last Updated: 2019-02-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-23

Study Completion Date

2006-04-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Bronchospasm Activity/Exercise Induced Bronchospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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FSC 100/50 mcg BID

Participants received FSC 100/50 microgram (mcg) one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days

Group Type EXPERIMENTAL

Fluticasone propionate/salmeterol

Intervention Type DRUG

Fluticasone propionate/salmeterol

FP 100 mcg BID

Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.

Group Type EXPERIMENTAL

Fluticasone Propionate

Intervention Type DRUG

Fluticasone Propionate

Interventions

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Fluticasone propionate/salmeterol

Fluticasone propionate/salmeterol

Intervention Type DRUG

Fluticasone Propionate

Fluticasone Propionate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Used systemic steroids as either liquids, pills, or injections to treat asthma within the previous 3 months.
* Have only intermittent, seasonal, or exercise-induced asthma, and not persistent asthma.
* Admitted to a hospital within the previous 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

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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

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Huntington Beach, California, United States

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GSK Investigational Site

Orange, California, United States

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Palmdale, California, United States

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Paramount, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Walnut Creek, California, United States

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Centennial, Colorado, United States

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Englewood, Colorado, United States

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Lakewood, Colorado, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Tallahassee, Florida, United States

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Lilburn, Georgia, United States

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Chicago, Illinois, United States

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Hoffman Estates, Illinois, United States

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Metairie, Louisiana, United States

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Metairie, Louisiana, United States

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Baltimore, Maryland, United States

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Glen Burnie, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Papillion, Nebraska, United States

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Skillman, New Jersey, United States

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Summit, New Jersey, United States

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Commack, New York, United States

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Utica, New York, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Gresham, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Erie, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Orangeburg, South Carolina, United States

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GSK Investigational Site

Dyersburg, Tennessee, United States

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GSK Investigational Site

Knoxville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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GSK Investigational Site

Murray, Utah, United States

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GSK Investigational Site

Richmond, Virginia, United States

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GSK Investigational Site

Greenfield, Wisconsin, United States

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Madison, Wisconsin, United States

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GSK Investigational Site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Pearlman D, Qaqundah P, Matz J, Yancey SW, Stempel DA, Ortega HG. Fluticasone propionate/salmeterol and exercise-induced asthma in children with persistent asthma. Pediatr Pulmonol. 2009 May;44(5):429-35. doi: 10.1002/ppul.20962.

Reference Type BACKGROUND
PMID: 19382218 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

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: Statistical Analysis Plan

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: Clinical Study Report

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

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http://www.findclinicalstudy.com

http://www.findclinicalstudy.com

Other Identifiers

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SFA100314

Identifier Type: -

Identifier Source: org_study_id

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