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An Open-Label, Multi-Center, Long Term Study to Investigate the Safety and Efficacy of Budesonide Turbuhaler Treatment for 48 Weeks (Following 6 Weeks Phase III Study) in Japanese Children With Bronchial Asthma Aged 5 Years to 15 Years Old

An Open-Label, Multi-Center, Long Term Study to Investigate the Safety and Efficacy of Budesonide Turbuhaler Treatment for 48 Weeks (Following 6 Weeks Phase III Study) in Japanese Children With Bronchial Asthma Aged 5 Years to 15 Years Old

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220437
Enrollment
Unknown
Registered
2007-09-04
Start date
2007-09-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

investigational material(s) Generic name etc : Budesonide INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administration for Inv

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ages Eligible for Study: 5 Years - 15 Years Genders Eligible for Study: Both Criteria Inclusion Criteria: - When the investigator will obtain the signed written informed consent of Phase III study (D5254C00769) from patient's legal representative, the investigator will also provide the information of this study Exclusion Criteria: - Respiratory infections that, in the opinion of the investigator(s), may affect the efficacy evaluation e.g., lower airways infection such as pneumonia, infection with no available effective antimicrobial drugs or with deep seated mycosis

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Safety Primary Outcome Measures: To investigate the safety of budesonide Turbuhaler with daily dose of 100 to 800ug for 54 weeks treatment including a prior 6 weeks phase III study D5254C00769 in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment [Time Frame: 54 weeks] Secondary Outcome Measures: To investigate the safety of budesonide Turbuhaler with a daily dose of 100 to 800ug for 26 weeks treatment including the prior 6 weeks phase III study in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment [Time Frame: 26 weeks]—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026