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Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Budesonide/Formoterol
Budesonide
Theophylline
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1 Prescribed daily use of an IGCS for >=12 weeks prior to Visit 1. The dose of IGCS must be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1 Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1 Exclusion Criteria: Any significant disease or disorder that may jeopardize the safety of the patient Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1 Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1 Additional inclusion and exclusion criteria will be evaluated by the Investigator

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Outcomes

Primary Outcome Measures

Morning peak expiratory flow (mPEF)

Secondary Outcome Measures

Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries
Forced expiratory volume in one second (FEV1)
Safety:
Adverse events (nature, incidence and severity)
Haematology, clinical chemistry and urinalysis
12-lead ECGs, blood pressure, pulse rate
- all variables assessed over the 8 week treatment period

Full Information

First Posted
November 11, 2005
Last Updated
January 21, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00252785
Brief Title
Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients
Official Title
An 8-week, Randomised, Double Blind, Parallel-group, Multi-centre, Phase III Study Comparing the Efficacy and Safety of Symbicort® Turbuhaler® 160/4.5 µg Twice Daily and Pulmicort® Turbuhaler® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Patients With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
340 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Budesonide/Formoterol
Other Intervention Name(s)
Symbicort
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Type
Drug
Intervention Name(s)
Theophylline
Primary Outcome Measure Information:
Title
Morning peak expiratory flow (mPEF)
Secondary Outcome Measure Information:
Title
Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries
Title
Forced expiratory volume in one second (FEV1)
Title
Safety:
Title
Adverse events (nature, incidence and severity)
Title
Haematology, clinical chemistry and urinalysis
Title
12-lead ECGs, blood pressure, pulse rate
Title
- all variables assessed over the 8 week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1 Prescribed daily use of an IGCS for >=12 weeks prior to Visit 1. The dose of IGCS must be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1 Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1 Exclusion Criteria: Any significant disease or disorder that may jeopardize the safety of the patient Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1 Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1 Additional inclusion and exclusion criteria will be evaluated by the Investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Symbicort Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Komaki
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Seto
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Asahi
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Noda
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Touon
State/Province
Ehime
Country
Japan
Facility Name
Research Site
City
Mizumaki
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Isesaki
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Ora
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Ota
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Chitose
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Kitahiroshima
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Obihiro
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Tomakomai
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Morioka
State/Province
Iwate
Country
Japan
Facility Name
Research Site
City
Takamatsu
State/Province
Kagawa
Country
Japan
Facility Name
Research Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Beppu
State/Province
Ohita
Country
Japan
Facility Name
Research Site
City
Tsukubo
State/Province
Okayama
Country
Japan
Facility Name
Research Site
City
Kishiwada
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Oskasayama
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Takatsuiki
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Koshigaya
State/Province
Saitama
Country
Japan
Facility Name
Research Site
City
Minamisaitama
State/Province
Saitama
Country
Japan
Facility Name
Research Site
City
Arakawa
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Chiyoda
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Itabashi
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Kodaira
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Nakano-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Ota-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Sumida
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Ube
State/Province
Yamaguchi
Country
Japan
Facility Name
Research Site
City
Gifu
Country
Japan
Facility Name
Research Site
City
Hiroshima
Country
Japan
Facility Name
Research Site
City
Kagoshima
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Oita
Country
Japan
Facility Name
Research Site
City
Okayama
Country
Japan
Facility Name
Research Site
City
Osaka
Country
Japan
Facility Name
Research Site
City
Tochigi
Country
Japan
Facility Name
Research Site
City
Toyama
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients

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