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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

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ClinicalTrials.gov Identifier: NCT00252785
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide/Formoterol Drug: Budesonide Drug: Theophylline Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : October 2005
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources


Intervention Details:
    Drug: Budesonide/Formoterol
    Other Name: Symbicort
    Drug: Budesonide Drug: Theophylline


Primary Outcome Measures :
  1. Morning peak expiratory flow (mPEF)

Secondary Outcome Measures :
  1. Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries
  2. Forced expiratory volume in one second (FEV1)
  3. Safety:
  4. Adverse events (nature, incidence and severity)
  5. Haematology, clinical chemistry and urinalysis
  6. 12-lead ECGs, blood pressure, pulse rate
  7. - all variables assessed over the 8 week treatment period


Information from the National Library of Medicine

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252785


Locations
Japan
Research Site
Komaki, Aichi, Japan
Research Site
Seto, Aichi, Japan
Research Site
Asahi, Chiba, Japan
Research Site
Noda, Chiba, Japan
Research Site
Touon, Ehime, Japan
Research Site
Mizumaki, Fukuoka, Japan
Research Site
Isesaki, Gunma, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Ora, Gunma, Japan
Research Site
Ota, Gunma, Japan
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
Research Site
Morioka, Iwate, Japan
Research Site
Takamatsu, Kagawa, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Beppu, Ohita, Japan
Research Site
Tsukubo, Okayama, Japan
Research Site
Kishiwada, Osaka, Japan
Research Site
Oskasayama, Osaka, Japan
Research Site
Takatsuiki, Osaka, Japan
Research Site
Koshigaya, Saitama, Japan
Research Site
Minamisaitama, Saitama, Japan
Research Site
Arakawa, Tokyo, Japan
Research Site
Chiyoda, Tokyo, Japan
Research Site
Itabashi, 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
Research Site
Ube, Yamaguchi, Japan
Research Site
Gifu, Japan
Research Site
Hiroshima, Japan
Research Site
Kagoshima, Japan
Research Site
Kyoto, Japan
Research Site
Oita, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Tochigi, Japan
Research Site
Toyama, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00252785     History of Changes
Other Study ID Numbers: D5890C00010
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol Fumarate
Budesonide
Theophylline
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Phosphodiesterase Inhibitors