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This study will include the patients who are Japanese children with bronchial asthma aged 5 years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of 100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks Phase III study (Study D5254C00769, NCT00504062) as compared with conventional therapy in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BUD - Budesonide | Experimental | Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily |
|
| CONV - Conventional Asthma Therapy | Active Comparator | Conventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events (AEs). | AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded. | 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Abnormal Clinical Laboratory Test Values. | Analysis of haematological, clinical chemistry and urynalysis variables were performed. Haematology variables: erythrocytes, haemoglobin, haematocrit, leucocyte count, leucocyte different count (neutrophils, eosinophils, basophils, lymphocytes, monocytes), platelet count. Clinical chemistry measurements: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin, creatinine,sodium, potassium, total protein, blood urea nitrogen. Urinalysis variables: protein, glucose, urobilinogen, occult. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars-Goran Carlsson, MD | AstraZeneca R&D Lund | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Takizawa | Iwate | Japan |
This was an open-label, multi-centre, long-term study in Japanese children with bronchial asthma aged 5 to 15 years, and conducted as an extension of the Phase III study D5254C00769.
241 Japanese paediatric patients were enrolled into the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Budesonide | Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily. |
| FG001 | Conventional Therapy | According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Budesonide | Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily. |
| BG001 | Conventional Therapy | According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Number of Patients With Adverse Events (AEs). | AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded. | Posted | Number | Participants | 54 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 | Budesonide | Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis Allergic | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | AZTrial_Results_Posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Conventional Asthma Therapy | Drug | According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. |
|
| 54 weeks |
| Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator | 54 weeks |
| Number of Patients With Abnormal Plasma Cortisol Values. | Cut-off value of cortisol is defined as 4 mcg/dL. | 54 weeks |
| Height | Height, change from baseline calculated as (height at last visit - height at randomization) | Baseline and 54 weeks |
| Weight | Weight, change from baseline calculated as (weight at last visit - weight at randomization) | Baseline and 54 weeks |
| Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal | Change in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization). | 54 weeks |
| Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime) | Change in respiratory condition at asthma attacks (daytime) from baseline to last visit. Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency | Baseline and 54 weeks |
| Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime) | Change in respiratory condition at asthma attacks (nighttime) from baseline calculated as (respiratory condition at asthma attacks (nighttime) at last visit - respiratory condition at asthma attacks (night-time) at randomization). Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency. | Baseline and 54 weeks |
| Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime) | Change in use of inhaled short-acting B-2 agonist (daytime) from baseline calculated as (use of inhaled short-acting B-2 agonist (daytime) at last visit - use of inhaled short-acting B-2 agonist (daytime) at randomization) | Baseline and 54 weeks |
| Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time) | Change in use of inhaled short-acting B-2 agonist (night-time) from baseline calculated as (use of inhaled short-acting B-2 agonist (night-time) at last visit - use of inhaled short-acting B-2 agonist (night-time) at randomization) | Baseline and 54 weeks |
| Change From Baseline in Disturbance of Daily Activities | Change in disturbance of daily activities from baseline calculated as (disturbance of daily activities at last visit - disturbance of daily activities at randomization). Frequency of disturbance of daily activity was assessed using 3- grade scale (normal, almost able, unable). | Baseline and 54 weeks |
| Change From Baseline in Disturbance of Night-time Sleep | Change in disturbance of night-time sleep from baseline calculated as (disturbances of night-time sleep at last visit - disturbances of night-time sleep at randomization). Frequency of disturbance of night- time sleep was assessed using 3- grade scale (normal, almost able, unable). | Baseline and 54 weeks |
| Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline | Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline calculated as: 100 * (FEV1 at last visit - FEV1 at randomization)/predicted normal FEV1). | 54 weeks |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Non-compliance |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Patients With Abnormal Clinical Laboratory Test Values. | Analysis of haematological, clinical chemistry and urynalysis variables were performed. Haematology variables: erythrocytes, haemoglobin, haematocrit, leucocyte count, leucocyte different count (neutrophils, eosinophils, basophils, lymphocytes, monocytes), platelet count. Clinical chemistry measurements: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin, creatinine,sodium, potassium, total protein, blood urea nitrogen. Urinalysis variables: protein, glucose, urobilinogen, occult. | Posted | Number | Participants | 54 weeks |
|
|
|
| Secondary | Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator | Posted | Number | Participants | 54 weeks |
|
|
|
| Secondary | Number of Patients With Abnormal Plasma Cortisol Values. | Cut-off value of cortisol is defined as 4 mcg/dL. | Posted | Number | Participants | 54 weeks |
|
|
|
| Secondary | Height | Height, change from baseline calculated as (height at last visit - height at randomization) | Posted | Mean | Standard Deviation | Centimeters | Baseline and 54 weeks |
|
|
|
| Secondary | Weight | Weight, change from baseline calculated as (weight at last visit - weight at randomization) | Posted | Mean | Standard Deviation | kilograms | Baseline and 54 weeks |
|
|
|
| Secondary | Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal | Change in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization). | Posted | Mean | Standard Deviation | Percentage | 54 weeks |
|
|
|
| Secondary | Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime) | Change in respiratory condition at asthma attacks (daytime) from baseline to last visit. Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency | Posted | Mean | Standard Deviation | Points on a scale | Baseline and 54 weeks |
|
|
|
| Secondary | Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime) | Change in respiratory condition at asthma attacks (nighttime) from baseline calculated as (respiratory condition at asthma attacks (nighttime) at last visit - respiratory condition at asthma attacks (night-time) at randomization). Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency. | Posted | Mean | Standard Deviation | Points on a scale | Baseline and 54 weeks |
|
|
|
| Secondary | Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime) | Change in use of inhaled short-acting B-2 agonist (daytime) from baseline calculated as (use of inhaled short-acting B-2 agonist (daytime) at last visit - use of inhaled short-acting B-2 agonist (daytime) at randomization) | Posted | Mean | Standard Deviation | Puffs per day | Baseline and 54 weeks |
|
|
|
| Secondary | Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time) | Change in use of inhaled short-acting B-2 agonist (night-time) from baseline calculated as (use of inhaled short-acting B-2 agonist (night-time) at last visit - use of inhaled short-acting B-2 agonist (night-time) at randomization) | Posted | Mean | Standard Deviation | Puffs per day | Baseline and 54 weeks |
|
|
|
| Secondary | Change From Baseline in Disturbance of Daily Activities | Change in disturbance of daily activities from baseline calculated as (disturbance of daily activities at last visit - disturbance of daily activities at randomization). Frequency of disturbance of daily activity was assessed using 3- grade scale (normal, almost able, unable). | Posted | Mean | Standard Deviation | Disturbances per day | Baseline and 54 weeks |
|
|
|
| Secondary | Change From Baseline in Disturbance of Night-time Sleep | Change in disturbance of night-time sleep from baseline calculated as (disturbances of night-time sleep at last visit - disturbances of night-time sleep at randomization). Frequency of disturbance of night- time sleep was assessed using 3- grade scale (normal, almost able, unable). | Posted | Mean | Standard Deviation | Disturbances per night | Baseline and 54 weeks |
|
|
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline | Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline calculated as: 100 * (FEV1 at last visit - FEV1 at randomization)/predicted normal FEV1). | Posted | Mean | Standard Deviation | Percentage | 54 weeks |
|
|
|
| 10 |
| 121 |
| 100 |
| 121 |
| EG001 | Conventional Therapy | According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. | 11 | 120 | 113 | 120 |
| Adenoviral conjunctivitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Otitis Media | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Chronic Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Acute Tonsillitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Heat Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |