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

Study Overview
=================
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.

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

Conditions
-----------------
Bronchospasm, Activity/Exercise Induced Bronchospasm

Intervention / Treatment
-----------------
* Drug: Fluticasone propionate/salmeterol
* Drug: Fluticasone Propionate


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FSC 100/50 mcg BID<br>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 | Drug: Fluticasone propionate/salmeterol<br>* Fluticasone propionate/salmeterol<br>|
| Experimental: FP 100 mcg BID<br>Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days. | Drug: Fluticasone Propionate<br>* Fluticasone Propionate<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, bronchospasm