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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 30, 2005
Last updated: March 24, 2009
Last verified: March 2009
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.

Condition Intervention Phase
Asthma Drug: Pulmicort (budesonide) Respules Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 54
Study Start Date: January 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   13 Months to 65 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00232648

Fukuoka-City, Fukuoka, Japan
Isehara-City, Kanagawa, Japan
Tsu-City, Mie, Japan
Kurashiki City, Okayama, Japan
Hioshima, Japan
Kanagawa, Japan
Matsuyama City, Japan
Obhu-city, Japan
Tokyo, Japan
Sponsors and Collaborators
Study Director: AstraZeneca KK RITA Medical Director AstraZeneca KK - Pharmaceuticals
  More Information Identifier: NCT00232648     History of Changes
Other Study ID Numbers: SD-004-0768
Study First Received: September 30, 2005
Last Updated: March 24, 2009

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 19, 2017