The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma during 12 weeks.
A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
882
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
Budesonide pMDI 80µg, 2 acuations twice daily
Change From Baseline to Week 12 in 1h Post-dose FEV1
1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 1h Post-dose PEF
1h post-dose PEF is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 1h Post-dose FEF25-75
1h post-dose FEF25-75 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 1h Post-dose FVC
1h post-dose FVC is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FEV1
Pre-dose FEV1 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose PEF
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Hoover, Alabama, United States
Research Site
Montgomery, Alabama, United States
Research Site
Gilbert, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Huntington Beach, California, United States
Research Site
Long Beach, California, United States
Research Site
Mission Viejo, California, United States
Research Site
Newport Beach, California, United States
Research Site
Ontario, California, United States
Research Site
Stockton, California, United States
...and 60 more locations
Pre-dose PEF is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FEF25-75
Pre-dose FEF25-75 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in Pre-dose FVC
Pre-dose FVC is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Week 12 in 15 Min Post-dose FEV1
15 min Post-dose FEV1 is defined as the 15 min post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in Total Asthma Symptoms
End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued). Patient to record his/her asthma symptom score twice daily. The following rating scales are to be used: 0 = None; no symptoms of asthma 1. = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated 2. = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep 3. = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep Total asthma symptom score is derived as the sum of the daytime score plus the score from the previous nighttime, ie possible range (0 to 6).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms
End of study average is defined as the percentage of nighttime awakenings due to asthma symptoms from 6 days before up to and additionally including the morning of withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to End of Study Average in Total Daily Reliever Medication
End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Time frame: Week 0 (baseline), Week 12
Change From Baseline to Study Period Average in Overall PAQLQ Score
Study period average is defined as the average of the post-baseline values during the study taken after first dose of investigational product up to and including withdrawal from study or Week 12, minus the baseline assessment at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued). The PAQLQ(S) is a 23-item patient-reported questionnaire, each one reported on a 7-point scale (e.g. 1 = extremely bothered/all of the time; 7 = not bothered/none of the time). The PAQLQ(S) generates an overall score, as well as 3 domain scores: activity limitations (5 items), symptoms (10 items) and emotional function (8 items). The overall score will be calculated as the mean of the responses to each of the 23 questions (ie the range of 1-7, where higher scores indicate better quality of life). If any of the domain scores are missing, no total score will be calculated.
Time frame: Week 0 (baseline), week 4, week 8, week 12
Number of Patients With an Asthma Exacerbation During Study
Number of patients that experienced an asthma exacerbation that required either emergency room treatment, hospitalization, systemic steroids, or an increase in, or additional asthma maintenance medication, during the study.
Time frame: Week 0 (baseline) up to Week 12