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Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Pulmicort (budesonide) Respules
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

13 Months - 65 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - 1. Clinical benefit from continued treatment with budesonide inhalation suspension was expected in patients with bronchial asthma participating in study SD-004-0765, as judged by the investigator(s) at the completion of that study (Visit 11, Week 24), and the patient's caregiver wished the continued treatment with budesonide inhalation suspension A written consent to participate in this study had been obtained from the patient's legal representative (a person who exercises parental authority for the patient, or if no one was applicable, a guardian: in principle, the patient's parent). 3. The patient was younger than 5 years old. Patients aged 5 years could be included in this study if no other effective treatment for the patient's bronchial asthma was available as judged by the investigator(s). Exclusion Criteria: -1. Concurrent severe diseases of liver, kidney, heart or other complications. 2. Contra-indications (eg, known or suspected allergy) to budesonide or excipients contained in the investigational product. 3. Other conditions, in which the investigator(s) judges patient's participation in this study inappropriate.

Sites / Locations

Outcomes

Primary Outcome Measures

The safety profile of long-term use of budesonide inhalation suspension assessed by evaluation of frequency and intensity of adverse events, plasma cortisol, physical examination, height, weight and clinical laboratory values.

Secondary Outcome Measures

The efficacy of budesonide inhalation suspension assessed by overall evaluation on asthma control by investigator

Full Information

First Posted
September 30, 2005
Last Updated
March 24, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00232648
Brief Title
Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma
Official Title
Investigation of Safety and Efficacy of Budesonide Inhalation Suspension in the Long-Term Use in Japanese Children With Bronchial Asthma (Open Long-Term Extension Study Following Study SD-004-0765
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
This study is as an extension study of SD-004-0765, to assess the safety profile of long-term use of budesonide inhalation suspension in Japanese young children with bronchial asthma. Children completing study SD-004-0765 continued administration of budesonide inhalation suspension as judged by the investigator; the dose is adjusted as appropriate within the range of 0.25 to 1.0 mg per day administered once or twice daily, according to the symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pulmicort (budesonide) Respules
Primary Outcome Measure Information:
Title
The safety profile of long-term use of budesonide inhalation suspension assessed by evaluation of frequency and intensity of adverse events, plasma cortisol, physical examination, height, weight and clinical laboratory values.
Secondary Outcome Measure Information:
Title
The efficacy of budesonide inhalation suspension assessed by overall evaluation on asthma control by investigator

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Months
Maximum Age & Unit of Time
65 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 1. Clinical benefit from continued treatment with budesonide inhalation suspension was expected in patients with bronchial asthma participating in study SD-004-0765, as judged by the investigator(s) at the completion of that study (Visit 11, Week 24), and the patient's caregiver wished the continued treatment with budesonide inhalation suspension A written consent to participate in this study had been obtained from the patient's legal representative (a person who exercises parental authority for the patient, or if no one was applicable, a guardian: in principle, the patient's parent). 3. The patient was younger than 5 years old. Patients aged 5 years could be included in this study if no other effective treatment for the patient's bronchial asthma was available as judged by the investigator(s). Exclusion Criteria: -1. Concurrent severe diseases of liver, kidney, heart or other complications. 2. Contra-indications (eg, known or suspected allergy) to budesonide or excipients contained in the investigational product. 3. Other conditions, in which the investigator(s) judges patient's participation in this study inappropriate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca KK RITA Medical Director
Organizational Affiliation
AstraZeneca KK - Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Fukuoka-City
State/Province
Fukuoka
Country
Japan
City
Isehara-City
State/Province
Kanagawa
Country
Japan
City
Tsu-City
State/Province
Mie
Country
Japan
City
Kurashiki City
State/Province
Okayama
Country
Japan
City
Hioshima
Country
Japan
City
Kanagawa
Country
Japan
City
Matsuyama City
Country
Japan
City
Obhu-city
Country
Japan
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma

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