Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma

NCT00509028 | Completed Phase 3 Results

• 1 other identifier: D5254C00006
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Bronchial

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adverse Events (AEs).

  AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.

  54 weeks

Secondary Outcomes (13)

• Number of Patients With Abnormal Clinical Laboratory Test Values.

  54 weeks

• Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator

  54 weeks

• Number of Patients With Abnormal Plasma Cortisol Values.

  54 weeks

• Height

  Baseline and 54 weeks

• Weight

  Baseline and 54 weeks

Study Arms (2)

BUD - Budesonide

EXPERIMENTAL

Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily

Drug: Budesonide

CONV - Conventional Asthma Therapy

ACTIVE COMPARATOR

Conventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Drug: Conventional Asthma Therapy

Interventions

Budesonide DRUG

Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily

Also known as: Pulmicort® Turbuhaler®

BUD - Budesonide

Conventional Asthma Therapy DRUG

According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

CONV - Conventional Asthma Therapy

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Takizawa, Iwate, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

AZTrial_Results_Posting@astrazeneca.com

Study Officials

• Lars-Goran Carlsson, MD

  AstraZeneca R&D Lund

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 31, 2007
• Study Start: December 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 27, 2012
• Results First Posted: August 27, 2012

Record last verified: 2012-07

Locations

JP (1)