JPRN-jRCT2080220398
Unknown
Phase 3
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
ConditionsAsthma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- AstraZeneca
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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