NCT01232348

Brief Summary

The purpose of this study is to confirm the safety (ADR related to beta stimulant drugs, unexpected ADRs) and efficacy of Symbicort in daily practice and the control status on bronchial asthma and Patient satisfaction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,643

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

December 7, 2011

Status Verified

December 1, 2011

Enrollment Period

1.7 years

First QC Date

October 31, 2010

Last Update Submit

December 6, 2011

Conditions

Bronchial Asthma

Keywords

bronchial asthmaSymbicort

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events

    Range of 12 weeks

Secondary Outcomes (2)

  • The level of asthma control

    Range of 12 weeks

  • The level of patient satisfaction with Symbicort

    Range of 12 weeks

Study Arms (1)

Symbicort

Those with an exposure

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 due to bronchial asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Research Site

Okazaki, Aichi-ken, Japan

Location

Research Site

Akita, Akita, Japan

Location

Research Site

Aomori, Aomori, Japan

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Chiba, Chiba, Japan

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Ehime, Ehime, Japan

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Fukui-shi, Fukui, Japan

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Fukuoka, Fukuoka, Japan

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Fukushima, Fukushima, Japan

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Gifu, Gifu, Japan

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Gunma, Gunma, Japan

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Hiroshima, Hiroshima, Japan

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Hokkaido, Hokkaido, Japan

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Hyogo, Hyōgo, Japan

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Ibaraki, Ibaraki, Japan

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Ishikawa, Ishikawa-ken, Japan

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Research Site

Numakunai, Iwate, Japan

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Kagawa, Kagawa-ken, Japan

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Kagoshima, Kagoshima-ken, Japan

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Kanagawa, Kanagawa, Japan

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Kochi, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Miemachi, Mie-ken, Japan

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Miyagi, Miyagi, Japan

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Miyazaki, Miyazaki, Japan

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Nagano, Nagano, Japan

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Nagasaki, Nagasaki, Japan

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Nara, Nara, Japan

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Niigata, Niigata, Japan

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Ōita, Oita Prefecture, Japan

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Okayama, Okayama-ken, Japan

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Okinawa, Okinawa, Japan

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Osaka, Osaka, Japan

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Saga, Saga-ken, Japan

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Saitama, Saitama, Japan

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Shiga, Shiga, Japan

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Shimane, Shimane, Japan

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Shizuoka, Shizuoka, Japan

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Tochigi, Tochigi, Japan

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Tokushima, Tokushima, Japan

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Tokyo, Tokyo, Japan

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Tottori-shi, Tottori, Japan

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Toyama, Toyama, Japan

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Research Site

Wakayama, Wakayama, Japan

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Research Site

Yamagata, Yamagata, Japan

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Research Site

Yamaguchi, Yamaguchi, Japan

Location

Research Site

Yamanashi, Yamanashi, Japan

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yoshida Shigeru, MD

    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

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 7, 2011

Record last verified: 2011-12

Locations

JP(47)