Back to resultsSafety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Budesonide
Conventional Asthma Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Bronchial
Eligibility Criteria
Inclusion Criteria:
- Patient who complete preceding the Phase III study and provide a signed written informed consent by patient's legal representative at Visit 1 or 4 weeks prior to Visit 1 of the study. A signed written informed assent should also be obtained from the patients themselves as much as possible
- When the investigator will obtain the signed written informed consent of Phase III study (D5254C00769) from patient's legal representative, the investigator will also provide the information of this study
Exclusion Criteria:
- Respiratory infections that, in the opinion of the investigator(s), may affect the efficacy evaluation e.g., lower airways infection such as pneumonia, infection with no available effective antimicrobial drugs or with deep seated mycosis
- Concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study. Any clinically relevant abnormal findings in vital sign or physical examination at Visit 1 in this study, which in the opinion of the investigator may put the patient at risk because of his/her participation in the study.
- Pregnant or possible pregnancy or planning to become pregnant during the study period
- Other subjects who are considered inappropriate to participate in this study judged by the investigator
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BUD - Budesonide
CONV - Conventional Asthma Therapy
Arm Description
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator
Number of Patients With Abnormal Plasma Cortisol Values.
Cut-off value of cortisol is defined as 4 mcg/dL.
Height
Height, change from baseline calculated as (height at last visit - height at randomization)
Weight
Weight, change from baseline calculated as (weight at last visit - weight at randomization)
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).
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
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.
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)
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)
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00509028
Brief Title
Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
Official Title
An Open-label, Multi-center, Long Term Study to Investigate the Safety and Efficacy of Budesonide Turbuhaler® Treatment for 48 Weeks (Following 6 Weeks Phase III Study) in Japanese Children With Bronchial Asthma Aged 5 Years to 15 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Bronchial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BUD - Budesonide
Arm Type
Experimental
Arm Description
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily
Arm Title
CONV - Conventional Asthma Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Pulmicort® Turbuhaler®
Intervention Description
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily
Intervention Type
Drug
Intervention Name(s)
Conventional Asthma Therapy
Intervention Description
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events (AEs).
Description
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.
Time Frame
54 weeks
Secondary Outcome Measure Information:
Title
Number of Patients With Abnormal Clinical Laboratory Test Values.
Description
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.
Time Frame
54 weeks
Title
Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator
Time Frame
54 weeks
Title
Number of Patients With Abnormal Plasma Cortisol Values.
Description
Cut-off value of cortisol is defined as 4 mcg/dL.
Time Frame
54 weeks
Title
Height
Description
Height, change from baseline calculated as (height at last visit - height at randomization)
Time Frame
Baseline and 54 weeks
Title
Weight
Description
Weight, change from baseline calculated as (weight at last visit - weight at randomization)
Time Frame
Baseline and 54 weeks
Title
Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal
Description
Change in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization).
Time Frame
54 weeks
Title
Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime)
Description
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
Time Frame
Baseline and 54 weeks
Title
Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime)
Description
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.
Time Frame
Baseline and 54 weeks
Title
Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime)
Description
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)
Time Frame
Baseline and 54 weeks
Title
Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time)
Description
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)
Time Frame
Baseline and 54 weeks
Title
Change From Baseline in Disturbance of Daily Activities
Description
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).
Time Frame
Baseline and 54 weeks
Title
Change From Baseline in Disturbance of Night-time Sleep
Description
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).
Time Frame
Baseline and 54 weeks
Title
Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline
Description
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).
Time Frame
54 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient who complete preceding the Phase III study and provide a signed written informed consent by patient's legal representative at Visit 1 or 4 weeks prior to Visit 1 of the study. A signed written informed assent should also be obtained from the patients themselves as much as possible
When the investigator will obtain the signed written informed consent of Phase III study (D5254C00769) from patient's legal representative, the investigator will also provide the information of this study
Exclusion Criteria:
Respiratory infections that, in the opinion of the investigator(s), may affect the efficacy evaluation e.g., lower airways infection such as pneumonia, infection with no available effective antimicrobial drugs or with deep seated mycosis
Concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study. Any clinically relevant abnormal findings in vital sign or physical examination at Visit 1 in this study, which in the opinion of the investigator may put the patient at risk because of his/her participation in the study.
Pregnant or possible pregnancy or planning to become pregnant during the study period
Other subjects who are considered inappropriate to participate in this study judged by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars-Goran Carlsson, MD
Organizational Affiliation
AstraZeneca R&D Lund
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Takizawa
State/Province
Iwate
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
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