MedTrace Logo

Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma

NCT00509028 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2012-08-27

Study results available
· View outcomes & findings →

Summary

This study will include the patients who are Japanese children with bronchial asthma aged 5 years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of 100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks Phase III study (Study D5254C00769, NCT00504062) as compared with conventional therapy in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment.

Conditions

Interventions

DRUG

Budesonide

Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily

DRUG

Conventional Asthma Therapy

According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Sponsors & Collaborators

Principal Investigators

  • Lars-Goran Carlsson, MD · AstraZeneca R&D Lund

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00509028 on ClinicalTrials.gov