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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252785
• Other study ID #: D5890C00010
• Status: Completed
• Phase: Phase 3
• First received: November 11, 2005
• Last updated: January 21, 2011
• Start date: October 2005
• Est. completion date: November 2006

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/Formoterol

• Budesonide

• Theophylline

Locations

Country	Name	City	State
Japan	Research Site	Arakawa	Tokyo
Japan	Research Site	Asahi	Chiba
Japan	Research Site	Beppu	Ohita
Japan	Research Site	Chitose	Hokkaido
Japan	Research Site	Chiyoda	Tokyo
Japan	Research Site	Gifu
Japan	Research Site	Hiroshima
Japan	Research Site	Isesaki	Gunma
Japan	Research Site	Itabashi	Tokyo
Japan	Research Site	Kagoshima
Japan	Research Site	Kishiwada	Osaka
Japan	Research Site	Kitahiroshima	Hokkaido
Japan	Research Site	Kodaira	Tokyo
Japan	Research Site	Komaki	Aichi
Japan	Research Site	Koshigaya	Saitama
Japan	Research Site	Kyoto
Japan	Research Site	Maebashi	Gunma
Japan	Research Site	Minamisaitama	Saitama
Japan	Research Site	Mizumaki	Fukuoka
Japan	Research Site	Morioka	Iwate
Japan	Research Site	Nakano-ku	Tokyo
Japan	Research Site	Noda	Chiba
Japan	Research Site	Obihiro	Hokkaido
Japan	Research Site	Oita
Japan	Research Site	Okayama
Japan	Research Site	Ora	Gunma
Japan	Research Site	Osaka
Japan	Research Site	Oskasayama	Osaka
Japan	Research Site	Ota	Gunma
Japan	Research Site	Ota-ku	Tokyo
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Sendai	Miyagi
Japan	Research Site	Seto	Aichi
Japan	Research Site	Shinagawa-ku	Tokyo
Japan	Research Site	Sumida	Tokyo
Japan	Research Site	Takamatsu	Kagawa
Japan	Research Site	Takatsuiki	Osaka
Japan	Research Site	Tochigi
Japan	Research Site	Tomakomai	Hokkaido
Japan	Research Site	Touon	Ehime
Japan	Research Site	Toyama
Japan	Research Site	Tsukubo	Okayama
Japan	Research Site	Ube	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

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