This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS and long acting β2-agonist (LABA) and/or other anti-asthmatic drugs.

Condition	Intervention	Phase
Asthma	Drug: Budesonide/Formoterol	Phase III

Further study details as provided by AstraZeneca:

Primary Outcomes: Safety: Adverse events (nature, incidence and severity) Haematology, clinical chemistry, morning plasma cortisol, urinalysis, and ACTH challenge test 12-lead ECGs, blood pressure, pulse rate
Secondary Outcomes: Patient reported outcomes regarding disease status (incl. PEF), collected via diaries; Forced expiratory volume in one second (FEV1); - all variables assessed over the 52 week treatment period
Expected Total Enrollment:  120

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
• Prescribed daily use of at least one of the following:

Theophylline, long acting β2-agonist (LABA), other anti-asthmatic drugs (leucotrine antagonists, inhaled anti-cholinergics, Th2 cytokine inhibitor) for at least 4 weeks prior to Visit 1 at a constant dose

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00255255

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

Japan
      Research Site, Gifu,  Japan
      Research Site, Hiroshima,  Japan
      Research Site, Kagoshima,  Japan
      Research Site, Kochi,  Japan
Japan, Aichi
      Research Site, Komaki,  Aichi,  Japan
      Research Site, Seto,  Aichi,  Japan
Japan, Gunma
      Research Site, Maebashi,  Gunma,  Japan
      Research Site, Ora,  Gunma,  Japan
Japan, Hokkaido
      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, Okayama
      Research Site, Tsukubo,  Okayama,  Japan
      Research Site, Tsukubo-gun,  Okayama,  Japan
Japan, Osaka
      Research Site, Kishiwada,  Osaka,  Japan
      Research Site, Takatsuiki,  Osaka,  Japan
Japan, Tokyo
      Research Site, Ota-ku,  Tokyo,  Japan
      Research Site, Shinjuku-ku,  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:  D5890C00009
Last Updated:  December 8, 2005
Record first received:  November 17, 2005
ClinicalTrials.gov Identifier:  NCT00255255
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2006-01-10