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

• Register: JPRN
• Last refreshed on: 26 April 2013
• Main ID: JPRN-JapicCTI-070446
• Date of registration: 12/07/2010
• Primary sponsor: AstraZeneca
• Public 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
• Scientific 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
• Recruitment status: Complete
• URL: http://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-070446
• Study type: INTERVENTIONAL
• Study design: Randomized, Open Label, Active Control, Parallel Assignment Study

Countries of recruitment

Japan

Contacts

• Affiliation: AstraZeneca Corporate Communications

Key inclusion & exclusion criteria

Inclusion criteria: Ages Eligible for Study: 5 Years - 15 Years
Genders Eligible for Study: Both
Inclusion Criteria:
- 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 ug/day or beclomethasone dipropionate (BDP) 200 ug/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.
Exclusion criteria:

Age minimum: 5
Age maximum: 15
Gender: BOTH

Health Condition(s) or Problem(s) studied

Asthma

Primary Outcome(s)

Safety/Efficacy Primary Outcome Measures:To investigate the effect of budesonide Turbuhaler 100 ug/dose twice daily and 200 ug/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 ug/dose twice daily and 200 ug/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 ug/dose twice daily and 200 ug/dose twice daily for 6 weeks to that of fluticasone Diskus 50 ug/dose twice daily and 100 ug/dose twice daily for 6 weeks [Time Frame: 6 weeks]

Secondary ID(s)

NCT00504062