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

Condition(s) targeted: Asthma

Intervention: budesonide (Drug); fluticasone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Lars-Goran Carlsson, MD, Study Director, Affiliation: AstraZeneca R&D Lund

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome:

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

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

Minimum age: 5 Years. Maximum age: 15 Years. Gender(s): Both.

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

Research Site, Takizawa, Iwate, Japan

Starting date: October 2006
Ending date: October 2007
Last updated: December 17, 2007