This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
214
Breath actuated metered dose inhaler
Actuation counter pressured metered dose inhaler
Actuation counter pressured metered dose inhaler
Forced Expiratory Volume in 1 Second (FEV1) - Post Dose
Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Time frame: 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg
Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose
Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Time frame: Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg
Peak Expiratory Flow
Time frame: Recorded morning upon rising and evening before sleep for 14 weeks
Asthma Symptoms Score (Total)
The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome.
Time frame: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks
Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)
The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period.
Time frame: Recorded 6:00 - 11:00 AM for 14 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Huntington Beach, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
Rancho Mirage, California, United States
Research Site
Riverside, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
San Jose, California, United States
Research Site
Tallahassee, Florida, United States
...and 31 more locations
Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)
Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period.
Time frame: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks