Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Pulmicort (budesonide) Respules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Months
Maximum Age: 65 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pulmicort (budesonide) Respules|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety profile of long-term use of budesonide inhalation suspension assessed by evaluation of frequency and intensity of adverse events, plasma cortisol, physical examination, height, weight and clinical laboratory values. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of budesonide inhalation suspension assessed by overall evaluation on asthma control by investigator |  |  |