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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00509028

Purpose

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) as compared with conventional therapy in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment.

Condition	Intervention	Phase
Asthma	Drug: budesonide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	An Open-Label, Multi-Center, Long Term Study to Investigate the Safety and Efficacy of Budesonide Turbuhaler® Treatment for 48 Weeks (Following 6 Weeks Phase III Study) in Japanese Children With Bronchial Asthma Aged 5 Years to 15 Years Old

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To investigate the safety of budesonide Turbuhaler® with daily dose of 100 to 800μg for 54 weeks treatment including a prior 6 weeks phase III study D5254C00769 in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment [ Time Frame: 54 weeks ]

Secondary Outcome Measures:

To investigate the safety of budesonide Turbuhaler® with a daily dose of 100 to 800μg for 26 weeks treatment including the prior 6 weeks phase III study in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment [ Time Frame: 26 weeks ]

Estimated Enrollment:	240
Study Start Date:	December 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	5 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient who complete preceding the Phase III study and provide a signed written informed consent by patient's legal representative at Visit 1 or 4 weeks prior to Visit 1 of the study. A signed written informed assent should also be obtained from the patients themselves as much as possible
When the investigator will obtain the signed written informed consent of Phase III study (D5254C00769) from patient's legal representative, the investigator will also provide the information of this study

Exclusion Criteria:

Respiratory infections that, in the opinion of the investigator(s), may affect the efficacy evaluation e.g., lower airways infection such as pneumonia, infection with no available effective antimicrobial drugs or with deep seated mycosis
Concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study. Any clinically relevant abnormal findings in vital sign or physical examination at Visit 1 in this study, which in the opinion of the investigator may put the patient at risk because of his/her participation in the study.
Pregnant or possible pregnancy or planning to become pregnant during the study period
Other subjects who are considered inappropriate to participate in this study judged by the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509028

Locations

Japan, Iwate
Research Site
Takizawa, Iwate, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Lars-Goran Carlsson, MD

AstraZeneca R&D Lund

More Information

No publications provided

Study ID Numbers:	D5254C00006
Study First Received:	July 17, 2007
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00509028 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:

Asthma
Bronchial

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 20, 2009