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

Phase 3

• Conditions: Asthma

• Registration Number: JPRN-jRCT2080220398
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Ages Eligible for Study: 13 Months - 65 Months
Genders Eligible for Study: Both
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
2. 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. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety/Efficacy 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.