Skip to main content
OpenTrials
Completed

NCT Number: NCT00509028

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site

Takizawa, Iwate, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

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

Other names: Pulmicort® Turbuhaler®

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.

Primary outcomes

  1. Number of Patients With Adverse Events (AEs).

    Time frame: 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 outcomes

  1. Number of Patients With Abnormal Clinical Laboratory Test Values.

    Time frame: 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.

  2. 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

  3. Number of Patients With Abnormal Plasma Cortisol Values.

    Time frame: 54 weeks

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

  4. Height

    Time frame: Baseline and 54 weeks

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

  5. Weight

    Time frame: Baseline and 54 weeks

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

  6. Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal

    Time frame: 54 weeks

    Change in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization).

  7. Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime)

    Time frame: 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

  8. Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime)

    Time frame: 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.

  9. Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime)

    Time frame: 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)

  10. Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time)

    Time frame: 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)

  11. Change From Baseline in Disturbance of Daily Activities

    Time frame: 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).

  12. Change From Baseline in Disturbance of Night-time Sleep

    Time frame: 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).

  13. Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 31, 2007
Registry last updated
Aug 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.