The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective as Symbicort Turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
605
BF Spiromax will be administered per dose and schedule specified in the arm.
Symbicort Turbohaler will be administered per dose and schedule specified in the arm.
SYMBICORT placebo multi-dose dry powder inhaler (DPI) identical in appearance to SYMBICORT TURBOHALER will be administered per dose and schedule specified in the arm.
Change From Baseline in Weekly Average of Daily Trough (Predose and Pre-rescue Bronchodilator) Morning (AM) Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Baseline trough morning PEF was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline \[Day 1\]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline \[Day 1\]). For postdose weekly average of trough morning PEF measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning PEF values divided by the number of nonmissing assessments. The final value for change from baseline was calculated as the average of the weekly change from baseline averaged over 12 weeks.
Time frame: Baseline, Weeks 1 to 12 (averaged over 12 weeks)
Change From Baseline in Weekly Average of Daily Evening (PM) PEF Over the 12-Week Treatment Period
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Baseline was defined as the average value of the recorded (nonmissing) assessments over the 7 days prior to randomization. For postdose weekly average of evening PEF measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of evening PEF values divided by the number of nonmissing assessments. The final value for change from baseline was calculated as the average of the weekly change from baseline averaged over 12 weeks.
Time frame: Baseline, Weeks 1 to 12 (averaged over 12 weeks)
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SPIROMAX Placebo multi-dose dry powder inhaler (DPI) identical in appearance to BF SPIROMAX will be administered per dose and schedule specified in the arm.
Teva Investigational Site 33020
Grieskirchen, Austria
Teva Investigational Site 33019
Linz, Austria
Teva Investigational Site 33018
Wels, Austria
Teva Investigational Site 37029
Gozée, Belgium
Teva Investigational Site 37031
Halen, Belgium
Teva Investigational Site 37030
Jambes, Belgium
Teva Investigational Site 54056
Brno, Czechia
Teva Investigational Site 54061
Hradec Králové, Czechia
Teva Investigational Site 54068
Neratovice, Czechia
Teva Investigational Site 54063
Ostrava - Marianske Hory, Czechia
...and 104 more locations
Time frame: Baseline up to Week 12
Number of Participants With Signs of Oral Candidiasis (Thrush)
Examinations were performed by a qualified professional.
Time frame: Baseline, Week 4, Week 8, Week 12
Number of Participants With Positive Swab of Oral Candidiasis (Thrush)
Swab samples were collected by a qualified professional.
Time frame: Baseline, Week 4, Week 8, Week 12