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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Budesonide; Drug: Conventional Asthma Therapy	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	241 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	December 2006
Actual Primary Completion Date :	October 2008
Actual Study Completion Date :	October 2008

Arms and Interventions

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Arm	Intervention/treatment
Experimental: BUD - Budesonide; Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily	Drug: Budesonide; Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily; Other Name: Pulmicort® Turbuhaler®
Active Comparator: CONV - Conventional Asthma Therapy; 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; According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Outcome Measures

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Primary Outcome Measures :

1. Number of Patients With Adverse Events (AEs). [ Time Frame: 54 weeks ]
   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.

Secondary Outcome Measures :

1. Number of Patients With Abnormal Clinical Laboratory Test Values. [ Time Frame: 54 weeks ]

   Analysis of haematological, clinical chemistry and urynalysis variables were performed.

   Haematology variables: erythrocytes, haemoglobin, haematocrit, leucocyte count, leucocyte different count (neutrophils, eosinophils, basophils, lymphocytes, monocytes), platelet count.

   Clinical chemistry measurements: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin, creatinine,sodium, potassium, total protein, blood urea nitrogen.

   Urinalysis variables: protein, glucose, urobilinogen, occult.

2. Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator [ Time Frame: 54 weeks ]
3. Number of Patients With Abnormal Plasma Cortisol Values. [ Time Frame: 54 weeks ]
   Cut-off value of cortisol is defined as 4 mcg/dL.
4. Height [ Time Frame: Baseline and 54 weeks ]
   Height, change from baseline calculated as (height at last visit - height at randomization)
5. Weight [ Time Frame: Baseline and 54 weeks ]
   Weight, change from baseline calculated as (weight at last visit - weight at randomization)
6. Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal [ Time Frame: 54 weeks ]
   Change in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization).
7. Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime) [ Time Frame: Baseline and 54 weeks ]

   Change in respiratory condition at asthma attacks (daytime) from baseline to last visit. Scale: 0 - 4.

   0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency

8. Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime) [ Time Frame: Baseline and 54 weeks ]

   Change in respiratory condition at asthma attacks (nighttime) from baseline calculated as (respiratory condition at asthma attacks (nighttime) at last visit - respiratory condition at asthma attacks (night-time) at randomization).

   Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency.

9. Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime) [ Time Frame: Baseline and 54 weeks ]
   Change in use of inhaled short-acting B-2 agonist (daytime) from baseline calculated as (use of inhaled short-acting B-2 agonist (daytime) at last visit - use of inhaled short-acting B-2 agonist (daytime) at randomization)
10. Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time) [ Time Frame: Baseline and 54 weeks ]
    Change in use of inhaled short-acting B-2 agonist (night-time) from baseline calculated as (use of inhaled short-acting B-2 agonist (night-time) at last visit - use of inhaled short-acting B-2 agonist (night-time) at randomization)
11. Change From Baseline in Disturbance of Daily Activities [ Time Frame: Baseline and 54 weeks ]

    Change in disturbance of daily activities from baseline calculated as (disturbance of daily activities at last visit - disturbance of daily activities at randomization).

    Frequency of disturbance of daily activity was assessed using 3- grade scale (normal, almost able, unable).

12. Change From Baseline in Disturbance of Night-time Sleep [ Time Frame: Baseline and 54 weeks ]

    Change in disturbance of night-time sleep from baseline calculated as (disturbances of night-time sleep at last visit - disturbances of night-time sleep at randomization).

    Frequency of disturbance of night- time sleep was assessed using 3- grade scale (normal, almost able, unable).

13. Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline [ Time Frame: 54 weeks ]
    Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline calculated as: 100 * (FEV1 at last visit - FEV1 at randomization)/predicted normal FEV1).

Eligibility Criteria

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Ages Eligible for Study:	5 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Japan
Research Site
Takizawa, Iwate, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Lars-Goran Carlsson, MD	AstraZeneca R&D Lund

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00509028 History of Changes
Other Study ID Numbers:	D5254C00006
First Posted:	July 31, 2007
Results First Posted:	August 27, 2012
Last Update Posted:	August 27, 2012
Last Verified:	July 2012

Keywords provided by AstraZeneca:

Asthma; Bronchial

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Budesonide	Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists