NCT01232335

Brief Summary

The purpose of this study is to confirm the safety profile for long term treatment and maximize doses and the control status on bronchial asthma in daily clinical usage

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

47 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

3.3 years

First QC Date

October 31, 2010

Last Update Submit

May 28, 2013

Conditions

Keywords

bronchial asthmaSymbicortlong term use,

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events

    Range of one year

Secondary Outcomes (2)

  • The level of asthma control under long-term use

    At the end of 24 weeks

  • The level of asthma control under long-term use

    At the end of one year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with Symbicort for the first time due to bronchial asthma

You may qualify if:

  • Patients treated with Symbicort for the first time possibly at the higher dose due to bronchial asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Research Site

Aichi, Japan, Japan

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Research Site

Akita, Japan, Japan

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Aomori, Japan, Japan

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Chiba, Japan, Japan

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Ehime, Japan, Japan

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Fukui, Japan, Japan

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Fukuoka, Japan, Japan

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Fukushima, Japan, Japan

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Gifu, Japan, Japan

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Gunma, Japan, Japan

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Hiroshima, Japan, Japan

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Hokkaido, Japan, Japan

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Hyōgo, Japan, Japan

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Ibaraki, Japan, Japan

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Ishikawa, Japan, Japan

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Kagawa, Japan, Japan

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Kagoshima, Japan, Japan

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Kanagawa, Japan, Japan

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Kochi, Japan, Japan

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Kumamoto, Japan, Japan

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Kyoto, Japan, Japan

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Mie, Japan, Japan

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Miyagi, Japan, Japan

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Miyazaki, Japan, Japan

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Nagano, Japan, Japan

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Nagasaki, Japan, Japan

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Nara, Japan, Japan

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Niigata, Japan, Japan

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Numakunai, Japan, Japan

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Okayama, Japan, Japan

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Okinawa, Japan, Japan

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Osaka, Japan, Japan

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Ōita, Japan, Japan

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Saga, Japan, Japan

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Saitama, Japan, Japan

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Shiga, Japan, Japan

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Shimane, Japan, Japan

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Shizuoka, Japan, Japan

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Tochigi, Japan, Japan

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Tokushima, Japan, Japan

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Tokyo, Japan, Japan

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Tottori, Japan, Japan

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Toyama, Japan, Japan

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Wakayama, Japan, Japan

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Yamagata, Japan, Japan

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Yamaguchi, Japan, Japan

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Yamanashi, Japan, Japan

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Yoshida Shigeru

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2010

First Posted

November 2, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations