The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone propionate alone.
This was a 26 week, double blind, randomized, active-controlled safety study of Foradil in free combination with inhaled corticosteroid versus an inhaled corticosteroid alone in adults and adolescent patients with persistent asthma. The primary objective of the study was to demonstrate that the addition of formoterol fumarate to fluticasone propionate is non-inferior to fluticasone propionate alone in terms of the risk of composite serious asthma related events (asthma-related hospitalization, asthma-related intubation, and asthma-related death). The individual components of the composite primary endpoint (i.e., asthma-related hospitalization, asthma-related intubation and asthma-related death) will be assessed as a secondary safety endpoints. The efficacy assessment is the secondary objective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
827
Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler
Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler
Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler
Number of First Occurrence(s) of Any Composite Endpoint Including Asthma-related Hospitalizations, Intubations and Deaths During the Study at 26 Weeks
The primary safety endpoint was the number of first occurrence(s) of any composite endpoint. The composite events include asthma-related deaths, asthma-related intubations and asthma-related hospitalizations. The number of events includes all adjudication confirmed events, one patient could experience multiple events during the course of study; Event rate = 100 \* n patients with any events / total N patients in treatment group.
Time frame: 26 weeks
Number of Asthma Exacerbations at 26 Weeks
Number of asthma exacerbations events
Time frame: 26 weeks
Percentage of Days of School/Work Missed at 26 Weeks
The percentage of days of school/work missed during the treatment period (26 weeks). Overall percentage of school days missed for each student patient or of work days missed is calculated by total number of days missed divided by total days of treatment.
Time frame: 26 weeks
Percentage of Days With Limited Ability to Perform Normal Daily Activities at 26 Weeks
The percentage of days with limited ability to perform normal daily activities during the treatment period (26 weeks). Percentage is calculated as total number of days when the patient had limited ability to perform normal daily activities divided by total days of treatment.
Time frame: 26 weeks
Percentage of Days With Nighttime Awakenings at 26 Weeks
Percentage of days with nighttime awakenings during the treatment period (26 weeks)
Time frame: 26 weeks
Percentage of Days With no Rescue Medication Use at 26 Weeks
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Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler
Placebo to match formoterol one inhalation twice daily via dry powder inhaler
Novartis Investigative Site
Avondale, Arizona, United States
Novartis Investigative Site
North Hollywood, California, United States
Novartis Investigative Site
Bradenton, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Conyers, Georgia, United States
Novartis Investigative Site
Stone Mountain, Georgia, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Covington, Louisiana, United States
...and 17 more locations
Percentage of rescue free days is calculated as total number of days with no rescue medication was taken divided by total days of treatment.
Time frame: 26 weeks
Percentage of Days With no Symptoms at 26 Weeks
Percentage of days with no symptoms during the treatment period (26 weeks). Percentage is calculated as total number of days with no symptoms divided by total days of treatment.
Time frame: 26 weeks
Change From Baseline in Asthma Control Questionnaire (ACQ - 6) Total Score at Week 26
Change from baseline in Asthma control Questionnaire (ACQ - 6) total score at week 26. Results of the Asthma control questionnaire (ACQ-6); The average score of the six questions is calculated as the sum of scores divided by the number of questions that were answered at the time point, as long as there were at least 4 questions answered. The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a total score of 0 corresponds to no impairment and a total score of 6 corresponds to maximum impairment.
Time frame: baseline and 26 weeks
Unplanned Healthcare Utilization at Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 26)
Unplanned healthcare utilization by visit (Telephone contact with study doctor (MD); Telephone contact with other physician (MD) or healthcare provider (HCP); Unscheduled or unplanned visit to study doctor (including home visits); Unscheduled or unplanned visit to other physician or healthcare provider (including home visits); Emergency department or hospital visit (\< 24 hours); Hospital admission or Emergency department visit (\> 24 hours).
Time frame: Week 4, Week 12, and Week 26