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

NCT ID: NCT00255255

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Budesonide/Formoterol

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Symbicort Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Komaki, Aichi-ken, Japan

Site Status

Research Site

Seto, Aichi-ken, Japan

Site Status

Research Site

Gifu, Gifu, Japan

Site Status

Research Site

Ōwa, Gunma, Japan

Site Status

Research Site

Hiroshima, Hiroshima, Japan

Site Status

Research Site

Sapporo, Hokkaido, Japan

Site Status

Research Site

Tomakomai, Hokkaido, Japan

Site Status

Research Site

Morioka, Iwate, Japan

Site Status

Research Site

Takamatsu, Kagawa-ken, Japan

Site Status

Research Site

Kagoshima, Kagoshima-ken, Japan

Site Status

Research Site

Kochi, Kochi, Japan

Site Status

Research Site

Beppu, Ohita, Japan

Site Status

Research Site

Tsukubo-gun, Okayama-ken, Japan

Site Status

Research Site

Kishiwada, Osaka, Japan

Site Status

Research Site

Takatsuki, Osaka, Japan

Site Status

Research Site

Ōta-ku, Tokyo, Japan

Site Status

Research Site

Shinjuku-ku, Tokyo, Japan

Site Status

Research Site

Ube, Yamaguchi, Japan

Site Status

Countries

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Japan

Other Identifiers

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D5890C00009

Identifier Type: -

Identifier Source: org_study_id

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