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

AstraZeneca241 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

241

Conditions

Asthma

Interventions

BudesonideDRUG

Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily

Conventional Asthma TherapyDRUG

According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Takizawa, Iwate, Japan

Outcomes

Primary Outcomes

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.

Time frame: 54 weeks

Secondary Outcomes

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.

Time frame: 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

Time frame: 54 weeks

Number of Patients With Abnormal Plasma Cortisol Values.

Cut-off value of cortisol is defined as 4 mcg/dL.

Time frame: 54 weeks

Height

Height, change from baseline calculated as (height at last visit - height at randomization)

Time frame: Baseline and 54 weeks

Weight

Weight, change from baseline calculated as (weight at last visit - weight at randomization)

Time frame: Baseline and 54 weeks

Data from ClinicalTrials.gov

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