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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Spacer | Experimental | Budesonide/formoterol pMDI 40/2.25ug + spacer |
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| Without Spacer | Experimental | Budesonide/formoterol pMDI 40/2.25 ug |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol pMDI 40/2.25ug + spacer | Drug |
| ||
| Budesonide/formoterol pMDI 40/2.25 ug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, at 2 weeks and 4 weeks |
| Morning Peak Expiratory Flow (mPEF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomas Anderson, MD PhD | AstraZeneca | Study Director |
| Piotr Kuna, MD PhD | Uniwersytecki Spital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Budapest | Hungary | ||||
| Research Site |
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137 subjects enrolled; 30 non randomised: 26 failed inclusion criteria, 2 voluntary discontinuations, 1 incorrect enrolment, 1 adverse event. 107 subjects were randomised
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| ID | Title | Description |
|---|---|---|
| FG000 | With Spacer | Budesonide/formoterol pMDI 40/2.25ug + spacer |
| FG001 | Without Spacer | Budesonide/formoterol pMDI 40/2.25 ug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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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.
| Daily during run-in and daily during treatment period of 6 weeks |
| 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. | Daily during run-in and daily during treatment period of 6 weeks |
| 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. | Daily during run-in and daily during treatment period of 6 weeks |
| 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. | Daily during run-in and daily during treatment period of 6 weeks |
| 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. | Daily during run-in and daily during treatment period of 6 weeks |
| 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. | Daily during run-in and daily during treatment period of 6 weeks |
| 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. | Daily during run-in and daily during treatment period of 6 weeks |
| Debrecen |
| Hungary |
| Research Site | Kaposvár | Hungary |
| Research Site | Bialystok | Poland |
| Research Site | Bydgoszcz | Poland |
| Research Site | Bytom | Poland |
| Research Site | Karpacz | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lodz | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Moscow | Russia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | With Spacer | Budesonide/formoterol pMDI 40/2.25ug + spacer |
| BG001 | Without Spacer | Budesonide/formoterol pMDI 40/2.25 ug |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Geometric Mean | Full Range | Ratio | At baseline and 4 weeks |
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| 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. | Posted | Mean | Full Range | Liters | At baseline, at 2 weeks and 4 weeks |
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| 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. | Posted | Mean | Standard Deviation | Liters/min | Daily during run-in and daily during treatment period of 6 weeks |
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| 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. | Posted | Mean | Standard Deviation | Liters/min | Daily during run-in and daily during treatment period of 6 weeks |
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| 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. | Posted | Mean | Standard Deviation | Units on a scale | Daily during run-in and daily during treatment period of 6 weeks |
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| 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. | Posted | Mean | Standard Deviation | Units on a scale | Daily during run-in and daily during treatment period of 6 weeks |
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| 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. | Posted | Mean | Standard Deviation | Percentage of nights | Daily during run-in and daily during treatment period of 6 weeks |
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| 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. | Posted | Mean | Standard Deviation | Inhalations | Daily during run-in and daily during treatment period of 6 weeks |
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| 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. | Posted | Mean | Standard Deviation | Inhalations | Daily during run-in and daily during treatment period of 6 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | With Spacer | Budesonide/formoterol pMDI 40/2.25ug + spacer | 0 | 55 | 0 | 55 | ||
| EG001 | Without Spacer | Budesonide/formoterol pMDI 40/2.25 ug | 0 | 52 | 0 | 52 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D036501 | Metered Dose Inhalers |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009330 | Nebulizers and Vaporizers |
| D004864 | Equipment and Supplies |
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| Male |
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