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: NCT00118716
• Other study ID #: SFA100314
• Status: Completed
• Phase: Phase 4
• Start date: December 23, 2003
• Est. completion date: April 23, 2006

Study information

• Verified date: December 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• 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: 248
• Est. completion date: April 23, 2006
• Est. primary completion date: April 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Activity/Exercise Induced Bronchospasm
• Asthma, Exercise-Induced
• Bronchial Spasm
• Bronchospasm

Intervention

Drug:
• Fluticasone propionate/salmeterol
Fluticasone propionate/salmeterol
• Fluticasone Propionate
Fluticasone Propionate

Locations

Country	Name	City	State
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Centennial	Colorado
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Commack	New York
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Dyersburg	Tennessee
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Glen Burnie	Maryland
United States	GSK Investigational Site	Greenfield	Wisconsin
United States	GSK Investigational Site	Gresham	Oregon
United States	GSK Investigational Site	Hershey	Pennsylvania
United States	GSK Investigational Site	Hoffman Estates	Illinois
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Lakewood	Colorado
United States	GSK Investigational Site	Lilburn	Georgia
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mount Pleasant	South Carolina
United States	GSK Investigational Site	Murray	Utah
United States	GSK Investigational Site	North Dartmouth	Massachusetts
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Orangeburg	South Carolina
United States	GSK Investigational Site	Palmdale	California
United States	GSK Investigational Site	Papillion	Nebraska
United States	GSK Investigational Site	Paramount	California
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Skillman	New Jersey
United States	GSK Investigational Site	Summit	New Jersey
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Utica	New York
United States	GSK Investigational Site	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Following Exercise Challenge at Week 4	FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Maximal percent change in FEV1 following exercise challenge was defined as the percent change from pre-exercise baseline FEV1 to the minimum FEV1 collected within one hour following exercise challenge. Maximal percent change in FEV1 following exercise challenge was mean maximal percent change from pre-exercise baseline compared between treatment groups at Treatment Week 4. FEV1 was measured 5, 10, 15, 30, and 60 minutes post-exercise. The minimum FEV1 measured across these time points, regardless of any missing time points, will be used for the calculation of maximal percent change.	Baseline and Week 4
Secondary	Four-hour Serial Post-dose FEV1 Area Under the Curve (AUC) on Treatment Day 1	FEV1 AUC is mean AUC compared between treatment groups at Treatment Day 1. Baseline was defined as the pre-dose FEV1 measure from treatment Day 1. FEV1 AUC was calculated as the area of a trapezoid (calculated as the sum of the bases (top + bottom) divided by 2, then multiplied by width) above the baseline FEV1 area. For participants not completing a serial FEV1 measurement, the last observed post-dose FEV1 measurement was carried forward.	Immediately prior to dosing (0 time point), 30 minutes post-dose and 1, 2, 3, 4 hour post-dose on Day 1
Secondary	Change From Baseline in Morning Peak Expiratory Flow (AM PEF)	PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Each participant was instructed to perform triplicate PEF measurements in the morning. Change from baseline was calculated as the endpoint value minus the baseline value. For AM PEF, baseline was defined as the average of the AM PEF values recorded on the day of Visit 2 (7-14 [+ or -4] days after Visit1) plus the 6 preceding days since AM PEF was measured in the morning.	Baseline and Up to Week 4
Secondary	Change From Baseline in Evening (PM) PEF	PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication after the symptom measurement and any rescue albuterol/salbutamol inhalation aerosol use. Each participant was instructed to perform triplicate PEF measurements in the evening. Change from baseline was calculated as the endpoint value minus the baseline value. Baseline was defined as the average of the values from the 7 days preceding Visit 2 (7-14 [+ or -4] days after Visit1) since these measures were derived from data collected in the evening.	Baseline and up to Week 4
Secondary	Percent of Rescue-free Days	A rescue-free day was defined as a day when no supplemental albuterol was taken (i.e., 0 puffs recorded for both AM and PM assessments of albuterol use in the daily diary). Percent of rescue-free days was calculated as the number of rescue-free days, divided by the total number of days in the treatment period, multiplied by 100 for each participant.	Up to Week 4
Secondary	Percent of Symptom-free Days	A symptom-free day was defined as a day with no symptoms (i.e., a score of 0, indicating no asthma symptoms during the day or previous night, recorded in the daily diary). Percent of symptom-free days was calculated as the number of symptom-free days, divided by the total number of days in the treatment period, multiplied by 100 for each participant.	Up to Week 4
Secondary	Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ)	PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Participants responded to each question on a 7-point scale (7= not bothered at all and 1= extremely bothered). The overall PAQLQ score is the mean of all 23 responses (minimum score 1= 5+8+10/23 and maximum score 7= 35+56+70/23) and the individual domain scores are the means of the items in those domains (minimum: 5/5, 8/8, 10/10 and maximum: 35/5, 56/8, 70/10). Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Endpoint was defined from the last questionnaire collected during the double-blind treatment period or discontinuation visit (up to Week 4).	Baseline (Week 0) and up to Week 4