Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504062
• Other study ID #: D5254C00769
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2007
• Last updated: August 23, 2011
• Start date: October 2006
• Est. completion date: October 2007

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• budesonide

• fluticasone

Locations

Country	Name	City	State
Japan	Research Site	Takizawa	Iwate

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 weeks
Secondary	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		6 weeks
Secondary	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		6 weeks