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| Sponsored by: |
AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00232648 |
Purpose
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 |
| 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: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Eligibility| 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.
Contacts and Locations| 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 | |
| Study Director: | AstraZeneca KK RITA Medical Director | AstraZeneca KK - Pharmaceuticals |
More Information
| Study ID Numbers: | SD-004-0768 |
| Study First Received: | September 30, 2005 |
| Last Updated: | March 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00232648 History of Changes |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
|
Anti-Inflammatory Agents Bronchial Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Asthma Anti-Asthmatic Agents Hormones Glucocorticoids |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
|
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Asthma Hormones Glucocorticoids |
Pharmacologic Actions Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
