Asthma
Conditions
Keywords
Symbicort pMDI, spacer, children
Brief summary
The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).
Interventions
DRUGBudesonide/formoterol pMDI 40/2.25ug + spacer
DRUGBudesonide/formoterol pMDI 40/2.25 ug
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* children 6-11 years, diagnosed asthma treated * 6 months, PEF * 50% of predicted normal value pre-bronchodilator
Exclusion criteria
* current systemic glucocorticosteroids usage * current respiratory infection * any significant disease or disorder as judged by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Free Cortisol (UFC) | At baseline and 4 weeks | Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morning Peak Expiratory Flow (mPEF) | Daily during run-in and daily during treatment period of 6 weeks | Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry were estimated using linear interpolation. |
| Evening Peak Expiratory Flow (ePEF) | Daily during run-in and daily during treatment period of 6 weeks | Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation. Missing data between the first and last entry were estimated using linear interpolation. |
| Asthma Symptoms at Night | Daily during run-in and daily during treatment period of 6 weeks | Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms. |
| Forced Expiratory Volume in 1 Second (FEV1) | At baseline, at 2 weeks and 4 weeks | Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate. |
| Percentage of Nights With Awakenings Due to Asthma | Daily during run-in and daily during treatment period of 6 weeks | Change in Percentage of nights with awakenings, average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. |
| Use of Rescue Medication at Night | Daily during run-in and daily during treatment period of 6 weeks | Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. |
| Use of Rescue Medication at Day | Daily during run-in and daily during treatment period of 6 weeks | Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. |
| Asthma Symptoms at Day | Daily during run-in and daily during treatment period of 6 weeks | Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms. |
Countries
Hungary, Poland, Russia
Participant flow
Recruitment details
137 subjects enrolled; 30 non randomised: 26 failed inclusion criteria, 2 voluntary discontinuations, 1 incorrect enrolment, 1 adverse event. 107 subjects were randomised
Participants by arm
| Arm | Count |
|---|---|
| With Spacer Budesonide/formoterol pMDI 40/2.25ug + spacer | 55 |
| Without Spacer Budesonide/formoterol pMDI 40/2.25 ug | 52 |
| Total | 107 |
Baseline characteristics
| Characteristic | With Spacer | Without Spacer | Total |
|---|---|---|---|
| Age Continuous | 8.6 years | 8.9 years | 8.7 years |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 34 Participants | 30 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 52 |
| serious Total, serious adverse events | 0 / 55 | 0 / 52 |
Outcome results
Primary
Urinary Free Cortisol (UFC)
Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment
Time frame: At baseline and 4 weeks
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| With Spacer | Urinary Free Cortisol (UFC) | 0.86 Ratio |
| Without Spacer | Urinary Free Cortisol (UFC) | 1.03 Ratio |
Secondary
Asthma Symptoms at Day
Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.
Time frame: Daily during run-in and daily during treatment period of 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Spacer | Asthma Symptoms at Day | -0.25 Units on a scale | Standard Deviation 0.43 |
| Without Spacer | Asthma Symptoms at Day | -0.28 Units on a scale | Standard Deviation 0.41 |
Secondary
Asthma Symptoms at Night
Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.
Time frame: Daily during run-in and daily during treatment period of 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Spacer | Asthma Symptoms at Night | -0.20 Units on a scale | Standard Deviation 0.46 |
| Without Spacer | Asthma Symptoms at Night | -0.21 Units on a scale | Standard Deviation 0.39 |
Secondary
Evening Peak Expiratory Flow (ePEF)
Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation. Missing data between the first and last entry were estimated using linear interpolation.
Time frame: Daily during run-in and daily during treatment period of 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Spacer | Evening Peak Expiratory Flow (ePEF) | 27.00 Liters/min | Standard Deviation 27.7 |
| Without Spacer | Evening Peak Expiratory Flow (ePEF) | 15.30 Liters/min | Standard Deviation 23 |
Secondary
Forced Expiratory Volume in 1 Second (FEV1)
Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate.
Time frame: At baseline, at 2 weeks and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Spacer | Forced Expiratory Volume in 1 Second (FEV1) | 0.17 Liters | Full Range -0.38 |
| Without Spacer | Forced Expiratory Volume in 1 Second (FEV1) | 0.14 Liters | Full Range -0.34 |
Secondary
Morning Peak Expiratory Flow (mPEF)
Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry were estimated using linear interpolation.
Time frame: Daily during run-in and daily during treatment period of 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Spacer | Morning Peak Expiratory Flow (mPEF) | 28.70 Liters/min | Standard Deviation 24.6 |
| Without Spacer | Morning Peak Expiratory Flow (mPEF) | 19.50 Liters/min | Standard Deviation 25.1 |
Secondary
Percentage of Nights With Awakenings Due to Asthma
Change in Percentage of nights with awakenings, average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.
Time frame: Daily during run-in and daily during treatment period of 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Spacer | Percentage of Nights With Awakenings Due to Asthma | -13.80 Percentage of nights | Standard Deviation 27.2 |
| Without Spacer | Percentage of Nights With Awakenings Due to Asthma | -8.20 Percentage of nights | Standard Deviation 23.8 |
Secondary
Use of Rescue Medication at Day
Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.
Time frame: Daily during run-in and daily during treatment period of 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Spacer | Use of Rescue Medication at Day | -0.30 Inhalations | Standard Deviation 0.56 |
| Without Spacer | Use of Rescue Medication at Day | -0.19 Inhalations | Standard Deviation 0.41 |
Secondary
Use of Rescue Medication at Night
Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.
Time frame: Daily during run-in and daily during treatment period of 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Spacer | Use of Rescue Medication at Night | -0.21 Inhalations | Standard Deviation 0.5 |
| Without Spacer | Use of Rescue Medication at Night | -0.14 Inhalations | Standard Deviation 0.38 |