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Open-Label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma
This study has been completed.
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00504062
  Purpose

To investigate the effect and safety of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment. To compare the efficacy of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks to that of fluticasone Diskus® 50 μg/dose and 100 μg/dose twice daily for 6 week.


Condition Intervention Phase
Asthma
Drug: budesonide
Drug: fluticasone
Phase III

MedlinePlus related topics: Asthma
Drug Information available for: Fluticasone Fluticasone propionate Budesonide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Open-Label, Parallel-Group, 6 Week Treatment, Multi-Center, Phase III Study to Investigate the Efficacy and Safety of 100ug and 200ug Twice Daily of Budesonide Turbuhaler® and 50ug and 100umg Twice Daily of Fluticasone Diskus® in Japanese Children With Bronchial Asthma Aged 5-15

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To investigate the effect of budesonide Turbuhaler® 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • To investigate the safety of budesonide Turbuhaler 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment [ Time Frame: 6 weeks ]
  • To compare the efficacy of budesonide Turbuhaler 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks to that of fluticasone Diskus® 50 μg/dose twice daily and 100 μg/dose twice daily for 6 weeks [ Time Frame: 6 weeks ]

Enrollment: 240
Study Start Date: October 2006
Study Completion Date: October 2007
  Eligibility

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

Inclusion Criteria:

  • Provision of signed written informed consent by patient's legal representative; when possible a signed written informed consent should be obtained from the patient themselves
  • Patients diagnosed as having bronchial asthma regardless of type of asthma i.e. perennial or seasonal, atopic or non-atopic
  • Males/females 5-15 yrs old who are able to experience to inhale with turbuhaler and diskus. the investigator will check whether the patient can inhale appropriately using training devises and "Turbuhaler trainer"
  • Patients with bronchial asthma who require treatment with inhaled steroids (patients with drug therapy, in whom asthma is poorly controlled)
  • Patients who are already treated with inhaled GCS should have at least 3 months prehistory of asthma before obtaining the written informed consent

Exclusion Criteria:

  • Use of regular(more than 3 days) systemic (oral, intravenous or intramuscular) steroids within 30 days before the observation period
  • The daily dose of inhaled GCS within 30 days before the observation period for the patients who are already treated with inhaled GCS is beyond fluticasone propionate (FP) 200 µg/day or beclomethasone dipropionate (BDP) 200 μg/day.
  • 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 within 30 days before the observation period.
  • Concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator(s), 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
  • Contra-indications (e.g., known or suspected allergy) to budesonide, fluticasone or lactose contained in the investigational product
  • Participation in another clinical study within 12 weeks prior to the observation period or during the study
  • Previous enrolment in the present study
  • Current use of budesonide turbuhaler
  • Pregnancy or possible pregnancy, or planning to be pregnant during the study period
  • Patients whose legal representative/caregiver is involved in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
  • Other subjects who are considered inappropriate to participate in this study as judged by the investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504062

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

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: D5254C00769
Study First Received: July 17, 2007
Last Updated: December 17, 2007
ClinicalTrials.gov Identifier: NCT00504062  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
asthma
bronchial

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Budesonide
Hypersensitivity, Immediate
Fluticasone
Asthma
Respiratory Hypersensitivity

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
Anti-Asthmatic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009