The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone. ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.
Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is complete.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
11,751
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/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months
fluticasone propionate (100) twice daily (AM and PM) for 6 months
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months
GSK Investigational Site
Athens, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Florence, Alabama, United States
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. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.
Time frame: From Day 1 up to 26 weeks
Number of Participants Experiencing at Least One Asthma Exacerbation
An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Time frame: From Day 1 up to 26 weeks
Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and 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 frame: From Day 1 up to 26 weeks
Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation
An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Time frame: From Day 1 up to 26 weeks
Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours
Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.
Time frame: From Day 1 up to 26 weeks
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GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Montgomery, Alabama, United States
GSK Investigational Site
Pell City, Alabama, United States
GSK Investigational Site
Scottsboro, Alabama, United States
GSK Investigational Site
Toney, Alabama, United States
...and 798 more locations