Status:
COMPLETED
Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
13-65 years
Phase:
PHASE3
Brief Summary
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 complet...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00232648
Start Date
January 1 2004
End Date
November 1 2006
Last Update
March 25 2009
Active Locations (9)
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1
Fukuoka, Fukuoka, Japan
2
Isehara, Kanagawa, Japan
3
Tsu, Mie-ken, Japan
4
Kurashiki, Okayama-ken, Japan