The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in May of 2016. This is the final update, as this study is complete.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6,250
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
fluticasone propionate (100) twice daily (AM and PM) for 6 months
Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)
Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a \>=24-hour stay in an observation area in an emergency department or other equivalent facility. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.
Time frame: From Day 1 up to 6 months
Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period
Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.
Time frame: From Day 1 up to 6 months
Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.
Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.
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fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Montgomery, Alabama, United States
GSK Investigational Site
Scottsboro, Alabama, United States
GSK Investigational Site
Toney, Alabama, United States
GSK Investigational Site
Tuscaloosa, Alabama, United States
GSK Investigational Site
Dothan, Alaska, United States
GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
...and 520 more locations
Time frame: From Day 1 up to 6 months
Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period
Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented.
Time frame: From Day 1 up to 6 months
Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period
Hospitalization is defined as a \>=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented.
Time frame: From Day 1 up to 6 months
Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period
An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.
Time frame: From Day 1 up to 6 months
Percentage of Rescue-free Days Over the 6-month Study Treatment Period
Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.
Time frame: From Day 1 up to 6 months
Percentage of Asthma Control Days Over the 6-month Study Treatment Period
An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was \<=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.
Time frame: From Day 1 up to 6 months