Clinical trial NCT00509028: Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Bronchial
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-31
Enrollment: 241
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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, NCT00504062) as compared with conventional therapy in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment.


Eligibility 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

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs).
timeFrame: 54 weeks
Secondary outcomes:
measure: Number of Patients With Abnormal Clinical Laboratory Test Values.
timeFrame: 54 weeks
measure: Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator
timeFrame: 54 weeks
measure: Number of Patients With Abnormal Plasma Cortisol Values.
timeFrame: 54 weeks
measure: Height
timeFrame: Baseline and 54 weeks
measure: Weight
timeFrame: Baseline and 54 weeks
measure: Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal
timeFrame: 54 weeks
measure: Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime)
timeFrame: Baseline and 54 weeks
measure: Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime)
timeFrame: Baseline and 54 weeks
measure: Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime)
timeFrame: Baseline and 54 weeks
measure: Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time)
timeFrame: Baseline and 54 weeks
measure: Change From Baseline in Disturbance of Daily Activities
timeFrame: Baseline and 54 weeks
measure: Change From Baseline in Disturbance of Night-time Sleep
timeFrame: Baseline and 54 weeks
measure: Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline
timeFrame: 54 weeks
Other outcomes:
Locations:
city: Takizawa
country: Japan
facility: Research Site
state: Iwate
Study officials:
affiliation: AstraZeneca R&D Lund
name: Lars-Goran Carlsson, MD
role: STUDY_DIRECTOR
References: