Asthma
Conditions
Keywords
asthma, children, budesonide pMDI
Brief summary
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.
Detailed description
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
Interventions
DRUGSymbicort pMDI
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
OTHERBudesonide pMDI
Budesonide pMDI 80µg, 2 acuations twice daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2 * Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to 100% of predicted normal * Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol.
Exclusion criteria
* Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1 * Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in 1h Post-dose FEV1 | Week 0 (baseline), Week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in 1h Post-dose FEF25-75 | Week 0 (baseline), Week 12 | 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). |
| Change From Baseline to Week 12 in 1h Post-dose FVC | Week 0 (baseline), Week 12 | 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). |
| Change From Baseline to Week 12 in Pre-dose FEV1 | Week 0 (baseline), Week 12 | 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). |
| Change From Baseline to Week 12 in Pre-dose PEF | Week 0 (baseline), Week 12 | 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). |
| Change From Baseline to Week 12 in Pre-dose FEF25-75 | Week 0 (baseline), Week 12 | 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). |
| Change From Baseline to Week 12 in Pre-dose FVC | Week 0 (baseline), Week 12 | 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). |
| Change From Baseline to Week 12 in 1h Post-dose PEF | Week 0 (baseline), Week 12 | 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). |
| Change From Baseline to End of Study Average in Total Asthma Symptoms | Week 0 (baseline), Week 12 | 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). |
| Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms | Week 0 (baseline), Week 12 | 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). |
| Change From Baseline to End of Study Average in Total Daily Reliever Medication | Week 0 (baseline), Week 12 | 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). |
| Change From Baseline to Study Period Average in Overall PAQLQ Score | Week 0 (baseline), week 4, week 8, week 12 | 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. |
| Number of Patients With an Asthma Exacerbation During Study | Week 0 (baseline) up to Week 12 | 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. |
| Change From Baseline to Week 12 in 15 Min Post-dose FEV1 | Week 0 (baseline), Week 12 | 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). |
Countries
Mexico, Panama, Slovakia, United States
Participant flow
Pre-assignment details
The enrollment number in the protocol section denotes the number of patients screened into the trial. Out of these 882 patients screened, 279 patients were randomized into the trial. This explains the discrepancy in patient number.
Participants by arm
| Arm | Count |
|---|---|
| Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/4.5 ug x 2 BID | 92 |
| Symbicort pMDI 80/2.25 ug Symbicort pMDI 80/4.5 ug x 2 BID | 95 |
| Budesonide pMDI 80 ug Budesonide pMDI 80 ug x 2 BID | 92 |
| Total | 279 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | 7 rand in error 1 patient decision | 2 | 3 | 3 |
| Overall Study | Adverse Event | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 8 | 3 |
Baseline characteristics
| Characteristic | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/2.25 ug | Budesonide pMDI 80 ug | Total |
|---|---|---|---|---|
| Age, Continuous | 9 years STANDARD_DEVIATION 1.6 | 9 years STANDARD_DEVIATION 1.6 | 9 years STANDARD_DEVIATION 1.4 | 9 years STANDARD_DEVIATION 1.5 |
| Duration of asthma | 5.8 years STANDARD_DEVIATION 3 | 5.9 years STANDARD_DEVIATION 3.2 | 6.2 years STANDARD_DEVIATION 3.1 | 5.9 years STANDARD_DEVIATION 3.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 36 Participants | 32 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 59 Participants | 60 Participants | 173 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| FEV1 at randomisation | 1.58 Liters STANDARD_DEVIATION 0.42 | 1.57 Liters STANDARD_DEVIATION 0.33 | 1.62 Liters STANDARD_DEVIATION 0.36 | 1.59 Liters STANDARD_DEVIATION 0.37 |
| Height | 139 cm STANDARD_DEVIATION 11.1 | 138 cm STANDARD_DEVIATION 10.9 | 141 cm STANDARD_DEVIATION 10.5 | 139 cm STANDARD_DEVIATION 10.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 26 Participants | 26 Participants | 76 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 61 Participants | 60 Participants | 53 Participants | 174 Participants |
| Sex: Female, Male Female | 42 Participants | 34 Participants | 37 Participants | 113 Participants |
| Sex: Female, Male Male | 50 Participants | 61 Participants | 55 Participants | 166 Participants |
| Weight | 38 kg STANDARD_DEVIATION 12.9 | 38 kg STANDARD_DEVIATION 12.9 | 40 kg STANDARD_DEVIATION 13.6 | 39 kg STANDARD_DEVIATION 13.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 42 / 90 | 41 / 93 | 40 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 93 | 2 / 90 |
Outcome results
Primary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint.~Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to Week 12 in 1h Post-dose FEV1 | 0.28 Liters |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to Week 12 in 1h Post-dose FEV1 | 0.24 Liters |
| Budesonide pMDI 80 ug | Change From Baseline to Week 12 in 1h Post-dose FEV1 | 0.17 Liters |
p-value: 0.006Mixed Models Analysis
p-value: 0.063Mixed Models Analysis
p-value: 0.373Mixed Models Analysis
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms | -14.0 Percentage of nighttime awakenings | Standard Deviation 29.15 |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms | -17.3 Percentage of nighttime awakenings | Standard Deviation 33.16 |
| Budesonide pMDI 80 ug | Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms | -13.0 Percentage of nighttime awakenings | Standard Deviation 21.87 |
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to End of Study Average in Total Asthma Symptoms | -0.5 units on a scale | Standard Deviation 0.73 |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to End of Study Average in Total Asthma Symptoms | -0.6 units on a scale | Standard Deviation 0.73 |
| Budesonide pMDI 80 ug | Change From Baseline to End of Study Average in Total Asthma Symptoms | -0.4 units on a scale | Standard Deviation 0.55 |
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to End of Study Average in Total Daily Reliever Medication | -0.7 Number of reliever medication use | Standard Deviation 1.75 |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to End of Study Average in Total Daily Reliever Medication | -1.1 Number of reliever medication use | Standard Deviation 2.37 |
| Budesonide pMDI 80 ug | Change From Baseline to End of Study Average in Total Daily Reliever Medication | -0.7 Number of reliever medication use | Standard Deviation 1.37 |
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to Study Period Average in Overall PAQLQ Score | 0.46 unit on a scale |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to Study Period Average in Overall PAQLQ Score | 0.53 unit on a scale |
| Budesonide pMDI 80 ug | Change From Baseline to Study Period Average in Overall PAQLQ Score | 0.62 unit on a scale |
p-value: 0.098ANCOVA
p-value: 0.367ANCOVA
p-value: 0.449ANCOVA
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to Week 12 in 15 Min Post-dose FEV1 | 0.25 Liters |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to Week 12 in 15 Min Post-dose FEV1 | 0.19 Liters |
| Budesonide pMDI 80 ug | Change From Baseline to Week 12 in 15 Min Post-dose FEV1 | 0.15 Liters |
p-value: 0.015ANCOVA
p-value: 0.342ANCOVA
p-value: 0.138ANCOVA
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to Week 12 in 1h Post-dose FEF25-75 | 0.55 Liters per second |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to Week 12 in 1h Post-dose FEF25-75 | 0.47 Liters per second |
| Budesonide pMDI 80 ug | Change From Baseline to Week 12 in 1h Post-dose FEF25-75 | 0.23 Liters per second |
p-value: <0.001Mixed Models Analysis
p-value: 0.005Mixed Models Analysis
p-value: 0.326Mixed Models Analysis
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to Week 12 in 1h Post-dose FVC | 0.22 Liters |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to Week 12 in 1h Post-dose FVC | 0.16 Liters |
| Budesonide pMDI 80 ug | Change From Baseline to Week 12 in 1h Post-dose FVC | 0.17 Liters |
p-value: 0.276Mixed Models Analysis
p-value: 0.759Mixed Models Analysis
p-value: 0.165Mixed Models Analysis
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint.~Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to Week 12 in 1h Post-dose PEF | 57.04 Liters per minute |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to Week 12 in 1h Post-dose PEF | 41.14 Liters per minute |
| Budesonide pMDI 80 ug | Change From Baseline to Week 12 in 1h Post-dose PEF | 31.57 Liters per minute |
p-value: 0.001Mixed Models Analysis
p-value: 0.195Mixed Models Analysis
p-value: 0.032Mixed Models Analysis
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to Week 12 in Pre-dose FEF25-75 | 0.12 Liters per minute |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to Week 12 in Pre-dose FEF25-75 | 0.13 Liters per minute |
| Budesonide pMDI 80 ug | Change From Baseline to Week 12 in Pre-dose FEF25-75 | 0.09 Liters per minute |
p-value: 0.684Mixed Models Analysis
p-value: 0.621Mixed Models Analysis
p-value: 0.929Mixed Models Analysis
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to Week 12 in Pre-dose FEV1 | 0.11 Liters |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to Week 12 in Pre-dose FEV1 | 0.10 Liters |
| Budesonide pMDI 80 ug | Change From Baseline to Week 12 in Pre-dose FEV1 | 0.09 Liters |
p-value: 0.724Mixed Models Analysis
p-value: 0.909Mixed Models Analysis
p-value: 0.811Mixed Models Analysis
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to Week 12 in Pre-dose FVC | 0.11 Liters |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to Week 12 in Pre-dose FVC | 0.11 Liters |
| Budesonide pMDI 80 ug | Change From Baseline to Week 12 in Pre-dose FVC | 0.13 Liters |
p-value: 0.664Mixed Models Analysis
p-value: 0.747Mixed Models Analysis
p-value: 0.913Mixed Models Analysis
Secondary
Change From Baseline to Week 12 in Pre-dose PEF
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
Population: All patients randomized who:~* received at least one dose of study medication;~* the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Symbicort pMDI 80/4.5 ug | Change From Baseline to Week 12 in Pre-dose PEF | 27.73 Liters per minute |
| Symbicort pMDI 80/2.25 ug | Change From Baseline to Week 12 in Pre-dose PEF | 15.86 Liters per minute |
| Budesonide pMDI 80 ug | Change From Baseline to Week 12 in Pre-dose PEF | 16.01 Liters per minute |
p-value: 0.134Mixed Models Analysis
p-value: 0.985Mixed Models Analysis
p-value: 0.128Mixed Models Analysis
Secondary
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
Population: All patients randomized who:~* received at least one dose of study medication;~* data collected after randomisation. Patients accounted for according to the treatment they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Symbicort pMDI 80/4.5 ug | Number of Patients With an Asthma Exacerbation During Study | 9 Partcicipants |
| Symbicort pMDI 80/2.25 ug | Number of Patients With an Asthma Exacerbation During Study | 12 Partcicipants |
| Budesonide pMDI 80 ug | Number of Patients With an Asthma Exacerbation During Study | 12 Partcicipants |