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Sponsored by: |
AstraZeneca |
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00232648 |
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 completing study SD-004-0765 continued administration of budesonide inhalation suspension as judged by the investigator; the dose is adjusted as appropriate within the range of 0.25 to 1.0 mg per day administered once or twice daily, according to the symptoms.
Condition | Intervention | Phase |
Asthma |
Drug: Pulmicort (budesonide) Respules |
Phase III |
MedlinePlus related topics: | Asthma |
ChemIDplus related topics: | Budesonide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 54 |
Study Start Date: | January 2004 |
Study Completion Date: | February 2007 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 13 Months to 65 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 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. 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.
Japan | |||||
Kanagawa, Japan | |||||
Obhu-city, Japan | |||||
Hioshima, Japan | |||||
Matsuyama City, Japan | |||||
Tokyo, Japan | |||||
Japan, Fukuoka | |||||
Fukuoka-City, Fukuoka, Japan | |||||
Japan, Kanagawa | |||||
Isehara-City, Kanagawa, Japan | |||||
Japan, Mie | |||||
Tsu-City, Mie, Japan | |||||
Japan, Okayama | |||||
Kurashiki City, Okayama, Japan |
AstraZeneca |
Study Director: | AstraZeneca KK RITA Medical Director | AstraZeneca KK - Pharmaceuticals |
Study ID Numbers: | SD-004-0768 |
First Received: | September 30, 2005 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00232648 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
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