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

Condition(s) targeted: Asthma

Intervention: Pulmicort (budesonide) Respules (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca KK RITA Medical Director, Study Director, Affiliation: AstraZeneca KK - Pharmaceuticals

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.

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 design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Minimum age: 13 Months. Maximum age: 65 Months. Gender(s): Both.

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.

Kanagawa, Japan

Obhu-city, Japan

Hioshima, Japan

Matsuyama City, Japan

Tokyo, Japan

Fukuoka-City, Fukuoka, Japan

Isehara-City, Kanagawa, Japan

Tsu-City, Mie, Japan

Kurashiki City, Okayama, Japan

Starting date: January 2004
Ending date: February 2007
Last updated: January 11, 2008