drugset / Trial / NCT00232648

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

NCT00232648 ↗

Phase 3 Completed 54 enrolled AstraZeneca
RandomizedSingle-groupOpen-labelTreatment

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 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.

Timeline

Start
2004-01
Primary completion
2006-11
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 0.25 mg Inhaled
Subject Budesonide Small molecule 1 mg Inhaled

Indications