NCT01711840

Brief Summary

The purpose of the investigation is to confirm the safety of patients receiving Symbicort Turbuhaler as maintenance and reliever therapy ( Symbicort SMART) under the post-marketing actual use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,409

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

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

First Submitted

Initial submission to the registry

October 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

2.7 years

First QC Date

October 19, 2012

Last Update Submit

July 15, 2016

Conditions

Bronchial Asthma

Keywords

Bronchial asthmaSymbicort Turbuhaler

Outcome Measures

Primary Outcomes (1)

  • Adverse event incidence

    12 weeks

Study Arms (1)

Symbicort

Eligibility Criteria

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

Patients receiving Symbicort Turbuhaler as maintenance and reliever therapy for the first time due to 'bronchial asthma ',and possibly requiring as-needed inhalations during the observation period

You may qualify if:

  • Patients receiving Symbicort Turbuhaler as maintenance and reliever therapy for the first time due to 'bronchial asthma ',and possibly requiring as-needed inhalations during the observation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Research Site

Aichi, D589ll00001, Japan

Location

Research Site

Akita, D589ll00001, Japan

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Aomori, D589ll00001, Japan

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Chiba, D589ll00001, Japan

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Ehime, D589ll00001, Japan

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Fukui, D589ll00001, Japan

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Fukuoka, D589ll00001, Japan

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Fukushima, D589ll00001, Japan

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Gifu, D589ll00001, Japan

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Gunma, D589ll00001, Japan

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Hiroshima, D589ll00001, Japan

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Hokkaido, D589ll00001, Japan

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Hyōgo, D589ll00001, Japan

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Ibaraki, D589ll00001, Japan

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Ishikawa, D589ll00001, Japan

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Kagawa, D589ll00001, Japan

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Kagoshima, D589ll00001, Japan

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Kanagawa, D589ll00001, Japan

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Kochi, D589ll00001, Japan

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Kumamoto, D589ll00001, Japan

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Kyoto, D589ll00001, Japan

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Mie, D589ll00001, Japan

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Miyagi, D589ll00001, Japan

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Miyazaki, D589ll00001, Japan

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Nagano, D589ll00001, Japan

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Nagasaki, D589ll00001, Japan

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Nara, D589ll00001, Japan

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Niigata, D589ll00001, Japan

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Numakunai, D589ll00001, Japan

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Okayama, D589ll00001, Japan

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Okinawa, D589ll00001, Japan

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Osaka, D589ll00001, Japan

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Ōita, D589ll00001, Japan

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Saga, D589ll00001, Japan

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Saitama, D589ll00001, Japan

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Shiga, D589ll00001, Japan

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Shimane, D589ll00001, Japan

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Shizuoka, D589ll00001, Japan

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Tochigi, D589ll00001, Japan

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Tokushima, D589ll00001, Japan

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Tokyo, D589ll00001, Japan

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Tottori, D589ll00001, Japan

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Toyama, D589ll00001, Japan

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Wakayama, D589ll00001, Japan

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Yamagata, D589ll00001, Japan

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Research Site

Yamaguchi, D589ll00001, Japan

Location

Research Site

Yamanashi, D589ll00001, Japan

Location

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shigeru Yoshida, MD

    AstraZeneca KK

    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 19, 2012

First Posted

October 22, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

JP(47)