The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
742
Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Budesonide HFA pMDI 160 ug x 2 actuations BID
Total Number of Asthma Exacerbations
An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.
Time frame: 52 Weeks
Asthma Exacerbations
Number of participants with at least 1 exacerbation
Time frame: 52 Weeks
QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)
QT interval corrected using the Fridericia formula \[QTc (Frid)\] - Change from baseline to end of treatment
Time frame: Baseline and 52 weeks
Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment
Total ectopic ventricular (VE) beats - number of participants with shift from normal (\<50) to high (≥50) from baseline to visit 4.
Time frame: Baseline and 2 weeks (visit 4)
Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment
Total ectopic supraventricular (VE) beats - number of participants with shift normal (\<50) to high (≥50) from baseline to visit 4.
Time frame: Baseline and 2 weeks (visit 4)
Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment
Total ventricular runs - number of participants with shift normal (\<1) to high (≥1) from baseline to week 2.
Time frame: Baseline and 2 weeks (visit 4)
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Research Site
Birmingham, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Montgomery, Alabama, United States
Research Site
Muscle Shoals, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Buena Park, California, United States
Research Site
Foothill Ranch, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
...and 112 more locations
Diary Assessments - Rescue-free Day
Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered "no" to having used rescue medication that day
Time frame: baseline and 52 weeks
Diary Assessments - Symptom-free Day
Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered "no" to having symptoms that day
Time frame: baseline and 52 weeks
Diary Assessments - Asthma-control Day
Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered "no" to having symptoms and "0" to the use of rescue medication that day
Time frame: baseline and 52 weeks
Onset of Effect Questionnaire (OEQ)
Number of participants with positive response to Item 2 in questionnaire "During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of "strongly agree" or "somewhat agree"
Time frame: 1 week
Onset of Effect Questionnaire (OEQ)
Number of participants with positive response to Item 5 in questionnaire "During the past week, you were satisfied with how quickly you felt your study medication begin to work." The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of "strongly agree" or "somewhat agree"
Time frame: 1 week
Peak Expiratory Flow (PEF) in Morning
Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period.
Time frame: baseline and 52 weeks
Forced Expiratory Volume in One Second (FEV1)
Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period
Time frame: baseline and 52 weeks
Asthma Treatment Satisfaction Measure (ATSM)
Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction.
Time frame: Baseline and 52 weeks