Back to resultsA Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
Primary Purpose
Bronchospasm, Activity/Exercise Induced Bronchospasm
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluticasone propionate/salmeterol
Fluticasone Propionate
Sponsored by
About this trial
This is an interventional treatment trial for Bronchospasm focused on measuring asthma, bronchospasm
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
FSC 100/50 mcg BID
FP 100 mcg BID
Arm Description
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
Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00118716
Brief Title
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 23, 2003 (Actual)
Primary Completion Date
April 1, 2006 (Actual)
Study Completion Date
April 23, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchospasm, Activity/Exercise Induced Bronchospasm
Keywords
asthma, bronchospasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FSC 100/50 mcg BID
Arm Type
Experimental
Arm Description
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
Arm Title
FP 100 mcg BID
Arm Type
Experimental
Arm Description
Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate/salmeterol
Intervention Description
Fluticasone propionate/salmeterol
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate
Intervention Description
Fluticasone Propionate
Primary Outcome Measure Information:
Title
Maximal Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Following Exercise Challenge at Week 4
Description
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.
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Four-hour Serial Post-dose FEV1 Area Under the Curve (AUC) on Treatment Day 1
Description
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.
Time Frame
Immediately prior to dosing (0 time point), 30 minutes post-dose and 1, 2, 3, 4 hour post-dose on Day 1
Title
Change From Baseline in Morning Peak Expiratory Flow (AM PEF)
Description
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.
Time Frame
Baseline and Up to Week 4
Title
Change From Baseline in Evening (PM) PEF
Description
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.
Time Frame
Baseline and up to Week 4
Title
Percent of Rescue-free Days
Description
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.
Time Frame
Up to Week 4
Title
Percent of Symptom-free Days
Description
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.
Time Frame
Up to Week 4
Title
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Description
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).
Time Frame
Baseline (Week 0) and up to Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
GSK Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GSK Investigational Site
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
Facility Name
GSK Investigational Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
GSK Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
GSK Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
GSK Investigational Site
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
GSK Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
GSK Investigational Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
GSK Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
GSK Investigational Site
City
Lilburn
State/Province
Georgia
ZIP/Postal Code
30047
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
GSK Investigational Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60195
Country
United States
Facility Name
GSK Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
GSK Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
GSK Investigational Site
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
GSK Investigational Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
GSK Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
GSK Investigational Site
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
GSK Investigational Site
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
GSK Investigational Site
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
GSK Investigational Site
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
GSK Investigational Site
City
Utica
State/Province
New York
ZIP/Postal Code
13502
Country
United States
Facility Name
GSK Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
GSK Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
GSK Investigational Site
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
GSK Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
GSK Investigational Site
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Facility Name
GSK Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19135
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
GSK Investigational Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
GSK Investigational Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
GSK Investigational Site
City
Dyersburg
State/Province
Tennessee
ZIP/Postal Code
38024
Country
United States
Facility Name
GSK Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
GSK Investigational Site
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
GSK Investigational Site
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
GSK Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
19382218
Citation
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100314
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100314
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100314
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100314
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100314
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100314
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
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