Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: budesonide (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Lars-Goran Carlsson, MD, Study Director, Affiliation: AstraZeneca R&D Lund
Summary
This study will include the patients who are Japanese children with bronchial asthma aged 5
years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at
about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of
100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks Phase III study (Study
D5254C00769) as compared with conventional therapy in Japanese children with bronchial
asthma in need of inhaled glucocorticosteroid treatment.
Clinical Details
Official title: 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
Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Primary outcome: To investigate the safety of budesonide Turbuhaler® with daily dose of 100 to 800μg 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
Secondary outcome: To investigate the safety of budesonide Turbuhaler® with a daily dose of 100 to 800μg for 26 weeks treatment including the prior 6 weeks phase III study in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment
Eligibility
Minimum age: 5 Years.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient who complete preceding the Phase III study and provide a signed written
informed consent by patient's legal representative at Visit 1 or 4 weeks prior to
Visit 1 of the study. A signed written informed assent should also be obtained from
the patients themselves as much as possible
- 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
- Concurrent serious diseases of liver, kidney, heart or other complications which, in
the opinion of the investigator, may either put the patient at risk because of
participation in the study, or may influence the results of the study, or the
patient's ability to participate in the study. Any clinically relevant abnormal
findings in vital sign or physical examination at Visit 1 in this study, which in the
opinion of the investigator may put the patient at risk because of his/her
participation in the study.
- Pregnant or possible pregnancy or planning to become pregnant during the study period
- Other subjects who are considered inappropriate to participate in this study judged by
the investigator
Locations and Contacts
Research Site, Takizawa, Iwate, Japan
Additional Information
Starting date: December 2006
Ending date: November 2008
Last updated: January 11, 2008
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