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

NCT00252785 | Completed Phase 3

• 1 other identifier: D5890C00010
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 43

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.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Morning peak expiratory flow (mPEF)

Secondary Outcomes (7)

• 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

Interventions

Budesonide/Formoterol DRUG

Also known as: Symbicort

Budesonide DRUG

Theophylline DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (43)

Research Site

Komaki, Aichi-ken, Japan

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Seto, Aichi-ken, Japan

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Asahi, Chiba, Japan

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Noda, Chiba, Japan

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Touon, Ehime, Japan

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Miyaodai, Fukuoka, Japan

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Gifu, Gifu, Japan

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Isesaki, Gunma, Japan

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Maebashi, Gunma, Japan

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Ōta, Gunma, Japan

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Ōwa, Gunma, Japan

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Hiroshima, Hiroshima, Japan

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Chitose, Hokkaido, Japan

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Kitahiroshima, Hokkaido, Japan

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Obihiro, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Tomakomai, Hokkaido, Japan

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Morioka, Iwate, Japan

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Takamatsu, Kagawa-ken, Japan

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Kagoshima, Kagoshima-ken, Japan

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Kyoto, Kyoto, Japan

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Sendai, Miyagi, Japan

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Beppu, Ohita, Japan

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Ōita, Oita Prefecture, Japan

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Okayama, Okayama-ken, Japan

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Tsukubo, Okayama-ken, Japan

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Kishiwada, Osaka, Japan

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Osaka, Osaka, Japan

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Oskasayama, Osaka, Japan

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Takatsuiki, Osaka, Japan

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Koshigaya, Saitama, Japan

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Minamisaitama, Saitama, Japan

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Arakawa City, Tokyo, Japan

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Chiyoda City, Tokyo, Japan

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Kodaira, Tokyo, Japan

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Nakano-ku, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Sumida City, Tokyo, Japan

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tabashi City, Tokyo, Japan

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Toyama, Toyama, Japan

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Ube, Yamaguchi, Japan

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Tochigi, Japan

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MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug Combination; Budesonide; Theophylline

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• AstraZeneca Symbicort Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 11, 2005
• First Posted: November 15, 2005
• Study Start: October 1, 2005
• Study Completion: November 1, 2006
• Last Updated: January 24, 2011

Record last verified: 2011-01

Locations

JP (43)