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NCT00118690 Clinical Trial

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

Bronchospasm Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00118690
Other study ID # SFA100316
Secondary ID
Status Completed
Phase Phase 4
First received July 1, 2005
Last updated September 22, 2016
Start date December 2003
Est. completion date December 2005

Study information
Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 227
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 17 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fluticasone propionate/salmeterol

Locations
Country Name City State
United States GSK Investigational Site Altamonte Springs Florida
United States GSK Investigational Site Altoona Pennsylvania
United States GSK Investigational Site Bethesda Maryland
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Burke Virginia
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Delray Beach Florida
United States GSK Investigational Site Denver Colorado
United States GSK Investigational Site East Artesia California
United States GSK Investigational Site El Paso Texas
United States GSK Investigational Site El Paso Texas
United States GSK Investigational Site Englewood Colorado
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Huntington Beach California
United States GSK Investigational Site Iowa City Iowa
United States GSK Investigational Site Jonesboro Arkansas
United States GSK Investigational Site Kernersville North Carolina
United States GSK Investigational Site Lawrenceville Georgia
United States GSK Investigational Site Layton Utah
United States GSK Investigational Site Long Beach California
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Louisville Kentucky
United States GSK Investigational Site Madera California
United States GSK Investigational Site Marietta Georgia
United States GSK Investigational Site Medford Oregon
United States GSK Investigational Site Mission Viejo California
United States GSK Investigational Site Missoula Montana
United States GSK Investigational Site Mount Laurel New Jersey
United States GSK Investigational Site Mount Pleasant South Carolina
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site Normal Illinois
United States GSK Investigational Site Oakland California
United States GSK Investigational Site Oklahoma City Oklahoma
United States GSK Investigational Site Omaha Nebraska
United States GSK Investigational Site Orangeburg South Carolina
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Provo Utah
United States GSK Investigational Site Pueblo Colorado
United States GSK Investigational Site Robbinsdale Minnesota
United States GSK Investigational Site Rolling Hills Est California
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site Savannah Georgia
United States GSK Investigational Site Savannah Georgia
United States GSK Investigational Site South Burlington Vermont
United States GSK Investigational Site St. Petersburg Florida
United States GSK Investigational Site Sunset Louisiana
United States GSK Investigational Site Tampa Florida
United States GSK Investigational Site Tampa Florida
United States GSK Investigational Site Upland Pennsylvania
United States GSK Investigational Site Vista California

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. No
Secondary Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment. No
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