Trial Outcomes & Findings for A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg (NCT NCT02091986)
NCT ID: NCT02091986
Last Updated: 2017-04-10
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
882 participants
Primary outcome timeframe
Week 0 (baseline), Week 12
Results posted on
2017-04-10
Participant Flow
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.
Participant milestones
| Measure |
Symbicort pMDI 80/4.5 ug
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
Symbicort pMDI 80/4.5 ug x 2 BID
|
Budesonide pMDI 80 ug
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Overall Study
STARTED
|
92
|
95
|
92
|
|
Overall Study
COMPLETED
|
85
|
84
|
84
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
8
|
Reasons for withdrawal
| Measure |
Symbicort pMDI 80/4.5 ug
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
Symbicort pMDI 80/4.5 ug x 2 BID
|
Budesonide pMDI 80 ug
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Overall Study
7 rand in error 1 patient decision
|
2
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
3
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
Baseline Characteristics
A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg
Baseline characteristics by cohort
| Measure |
Symbicort pMDI 80/4.5 ug
n=92 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=95 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Budesonide pMDI 80 ug
n=92 Participants
Budesonide pMDI 80 ug x 2 BID
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
9 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
9 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
9 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
9 years
STANDARD_DEVIATION 1.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Weight
|
38 kg
STANDARD_DEVIATION 12.9 • n=5 Participants
|
38 kg
STANDARD_DEVIATION 12.9 • n=7 Participants
|
40 kg
STANDARD_DEVIATION 13.6 • n=5 Participants
|
39 kg
STANDARD_DEVIATION 13.1 • n=4 Participants
|
|
Height
|
139 cm
STANDARD_DEVIATION 11.1 • n=5 Participants
|
138 cm
STANDARD_DEVIATION 10.9 • n=7 Participants
|
141 cm
STANDARD_DEVIATION 10.5 • n=5 Participants
|
139 cm
STANDARD_DEVIATION 10.8 • n=4 Participants
|
|
Duration of asthma
|
5.8 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
5.9 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
6.2 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
5.9 years
STANDARD_DEVIATION 3.1 • n=4 Participants
|
|
FEV1 at randomisation
|
1.58 Liters
STANDARD_DEVIATION 0.42 • n=5 Participants
|
1.57 Liters
STANDARD_DEVIATION 0.33 • n=7 Participants
|
1.62 Liters
STANDARD_DEVIATION 0.36 • n=5 Participants
|
1.59 Liters
STANDARD_DEVIATION 0.37 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=90 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=93 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=90 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to Week 12 in 1h Post-dose FEV1
|
0.28 Liters
Interval 0.22 to 0.34
|
0.24 Liters
Interval 0.18 to 0.31
|
0.17 Liters
Interval 0.1 to 0.23
|
SECONDARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=89 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=93 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=90 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to Week 12 in 1h Post-dose PEF
|
57.04 Liters per minute
Interval 46.12 to 67.97
|
41.14 Liters per minute
Interval 30.26 to 52.01
|
31.57 Liters per minute
Interval 20.78 to 42.36
|
SECONDARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=89 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=93 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=90 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to Week 12 in 1h Post-dose FEF25-75
|
0.55 Liters per second
Interval 0.43 to 0.67
|
0.47 Liters per second
Interval 0.35 to 0.59
|
0.23 Liters per second
Interval 0.11 to 0.35
|
SECONDARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=89 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=93 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=90 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to Week 12 in 1h Post-dose FVC
|
0.22 Liters
Interval 0.15 to 0.3
|
0.16 Liters
Interval 0.09 to 0.23
|
0.17 Liters
Interval 0.1 to 0.24
|
SECONDARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=89 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=92 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=89 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Pre-dose FEV1
|
0.11 Liters
Interval 0.04 to 0.17
|
0.10 Liters
Interval 0.03 to 0.16
|
0.09 Liters
Interval 0.03 to 0.15
|
SECONDARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=89 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=92 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=89 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Pre-dose PEF
|
27.73 Liters per minute
Interval 16.37 to 39.08
|
15.86 Liters per minute
Interval 4.39 to 27.33
|
16.01 Liters per minute
Interval 4.5 to 27.52
|
SECONDARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=89 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=92 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=89 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Pre-dose FEF25-75
|
0.12 Liters per minute
Interval 0.01 to 0.24
|
0.13 Liters per minute
Interval 0.01 to 0.25
|
0.09 Liters per minute
Interval -0.03 to 0.21
|
SECONDARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=89 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=92 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=89 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to Week 12 in Pre-dose FVC
|
0.11 Liters
Interval 0.03 to 0.18
|
0.11 Liters
Interval 0.04 to 0.19
|
0.13 Liters
Interval 0.05 to 0.2
|
SECONDARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=79 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=78 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=80 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to Week 12 in 15 Min Post-dose FEV1
|
0.25 Liters
Interval 0.18 to 0.31
|
0.19 Liters
Interval 0.12 to 0.25
|
0.15 Liters
Interval 0.08 to 0.21
|
SECONDARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=70 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=72 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=73 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to End of Study Average in Total Asthma Symptoms
|
-0.5 units on a scale
Standard Deviation 0.73
|
-0.6 units on a scale
Standard Deviation 0.73
|
-0.4 units on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=79 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=85 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=82 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
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
|
-17.3 Percentage of nighttime awakenings
Standard Deviation 33.16
|
-13.0 Percentage of nighttime awakenings
Standard Deviation 21.87
|
SECONDARY outcome
Timeframe: Week 0 (baseline), Week 12Population: 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.
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).
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=70 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=72 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=73 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to End of Study Average in Total Daily Reliever Medication
|
-0.7 Number of reliever medication use
Standard Deviation 1.75
|
-1.1 Number of reliever medication use
Standard Deviation 2.37
|
-0.7 Number of reliever medication use
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: Week 0 (baseline), week 4, week 8, week 12Population: 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.
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.
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=79 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=80 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=82 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Change From Baseline to Study Period Average in Overall PAQLQ Score
|
0.46 unit on a scale
Interval 0.3 to 0.62
|
0.53 unit on a scale
Interval 0.38 to 0.69
|
0.62 unit on a scale
Interval 0.47 to 0.78
|
SECONDARY outcome
Timeframe: Week 0 (baseline) up to Week 12Population: 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.
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.
Outcome measures
| Measure |
Symbicort pMDI 80/4.5 ug
n=90 Participants
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=93 Participants
Symbicort pMDI 80/2.25 ug x 2 BID
|
Budesonide pMDI 80 ug
n=90 Participants
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Number of Patients With an Asthma Exacerbation During Study
|
9 Partcicipants
|
12 Partcicipants
|
12 Partcicipants
|
Adverse Events
Symbicort pMDI 80/4.5 ug
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Symbicort pMDI 80/2.25 ug
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Budesonide pMDI 80 ug
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Symbicort pMDI 80/4.5 ug
n=90 participants at risk
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=93 participants at risk
Symbicort pMDI 80/4.5 ug x 2 BID
|
Budesonide pMDI 80 ug
n=90 participants at risk
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
Other adverse events
| Measure |
Symbicort pMDI 80/4.5 ug
n=90 participants at risk
Symbicort pMDI 80/4.5 ug x 2 BID
|
Symbicort pMDI 80/2.25 ug
n=93 participants at risk
Symbicort pMDI 80/4.5 ug x 2 BID
|
Budesonide pMDI 80 ug
n=90 participants at risk
Budesonide pMDI 80 ug x 2 BID
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.8%
7/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
11.8%
11/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
11.1%
10/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
9/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
12.9%
12/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
4.4%
4/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
General disorders
Pyrexia
|
4.4%
4/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
4.3%
4/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
4.4%
4/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
4/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
5.6%
5/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.3%
3/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
3.2%
3/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
4.4%
4/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
4.3%
4/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
4.4%
4/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Infections and infestations
Pharyngitis
|
5.6%
5/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
3.2%
3/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Nervous system disorders
Headache
|
4.4%
4/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
4.3%
4/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Immune system disorders
Hypersensitivity
|
2.2%
2/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
2/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
3.2%
3/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Infections and infestations
Sinusitis
|
2.2%
2/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
1.1%
1/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Infections and infestations
Influenza
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Infections and infestations
Conjunctivitis
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Infections and infestations
Rhinitis
|
3.3%
3/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Infections and infestations
Viral upper respiratory tract
|
0.00%
0/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
1.1%
1/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
2/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
2/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.1%
1/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
2.2%
2/93 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
0.00%
0/90 • Week 0 (baseline) up to 12 weeks
Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who : * received at least 1 dose of study meds; * data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place