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.

Condition	Intervention	Phase
Asthma	Drug: Budesonide/Formoterol  Drug: Budesonide  Drug: Theophylline	Phase III

Further study details as provided by AstraZeneca:

Primary Outcomes: Morning peak expiratory flow (mPEF)
Secondary Outcomes: 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
Expected Total Enrollment:  340

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00252785

AstraZeneca Clinical Study Information       http://www.astrazeneca.com/node/emailtriage.aspx

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

Study chairs or principal investigators

AstraZeneca Symbicort Medical Science Director, MD,  Study Director,  AstraZeneca   

Study ID Numbers:  D5890C00010
Last Updated:  December 8, 2005
Record first received:  November 11, 2005
ClinicalTrials.gov Identifier:  NCT00252785
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2006-01-10