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Safety & Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: November 17, 2005
Last updated: January 21, 2011
Last verified: January 2011
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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Phase III, Multicentre, 52-week Study, Evaluating the Safety and Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 120
Study Start Date: November 2005
Study Completion Date: June 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Budesonide/Formoterol
    Other Name: Symbicort

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00255255

Research Site
Komaki, Aichi, Japan
Research Site
Seto, Aichi, Japan
Research Site
Ora, Gunma, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Tomakomai, Hokkaido, Japan
Research Site
Morioka, Iwate, Japan
Research Site
Takamatsu, Kagawa, Japan
Research Site
Beppu, Ohita, Japan
Research Site
Tsukubo-gun, Okayama, Japan
Research Site
Kishiwada, Osaka, Japan
Research Site
Takatsuki, Osaka, Japan
Research Site
Ota-ku, Tokyo, Japan
Research Site
Shinjuku-ku, Tokyo, Japan
Research Site
Ube, Yamaguchi, Japan
Research Site
Gifu, Japan
Research Site
Hiroshima, Japan
Research Site
Kagoshima, Japan
Research Site
Kochi, Japan
Sponsors and Collaborators
Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
  More Information Identifier: NCT00255255     History of Changes
Other Study ID Numbers: D5890C00009
Study First Received: November 17, 2005
Last Updated: January 21, 2011

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 21, 2017