Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma

Phase 3

Completed

Conditions: Asthma

Interventions: Drug: Budesonide
Drug: Conventional Asthma Therapy

Registration Number: NCT00509028

Lead Sponsor: AstraZeneca

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 241

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BUD - Budesonide	Budesonide	Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily
CONV - Conventional Asthma Therapy	Conventional Asthma Therapy	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events (AEs).	54 weeks	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

Name	Time	Method
Number of Patients With Abnormal Clinical Laboratory Test Values.	54 weeks	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	54 weeks
Number of Patients With Abnormal Plasma Cortisol Values.	54 weeks	Cut-off value of cortisol is defined as 4 mcg/dL.
Height	Baseline and 54 weeks	Height, change from baseline calculated as (height at last visit - height at randomization)
Weight	Baseline and 54 weeks	Weight, change from baseline calculated as (weight at last visit - weight at randomization)
Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal	54 weeks	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)	Baseline and 54 weeks	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)	Baseline and 54 weeks	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)	Baseline and 54 weeks	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)	Baseline and 54 weeks	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	Baseline and 54 weeks	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	Baseline and 54 weeks	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	54 weeks	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).