NCT01713075

Brief Summary

The purpose of the investigation is to confirm the safety and efficacy in long-term use of Symbicort Turbuhaler in patients with Chronic obstructive pulmonary disease (COPD) 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
1,183

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
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

October 19, 2012

Last Update Submit

October 27, 2016

Conditions

Keywords

chronic obstructive pulmonary diseaseSymbicortlong-term use

Outcome Measures

Primary Outcomes (1)

  • Adverse event incidence

    1 year

Secondary Outcomes (1)

  • Clinical questionnaire about chronic obstructive pulmonary disease(CCQ)

    At baseline, Week 12, Week 26, 1 year

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

Among patients treated with Symbicort Turbuhaler due to chronic obstructive pulmonary disease(COPD), those who received the drug for the first time

You may qualify if:

  • Among patients treated with Symbicort Turbuhaler due to chronic obstructive pulmonary disease(COPD), those who received the drug for the first time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Research Site

Aichi, Japan

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Akita, Japan

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Aomori, Japan

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Chiba, Japan

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Ehime, Japan

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Fukui, Japan

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Fukuoka, Japan

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Fukushima, Japan

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Gifu, Japan

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Gunma, Japan

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Hiroshima, Japan

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Hokkaido, Japan

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Hyōgo, Japan

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Ibaraki, Japan

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Ishikawa, Japan

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Kagawa, Japan

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Kagoshima, Japan

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Kanagawa, Japan

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Kochi, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Mie, Japan

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Miyagi, Japan

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Miyazaki, Japan

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Nagano, Japan

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Nagasaki, Japan

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Nara, Japan

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Niigata, Japan

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Numakunai, Japan

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Okayama, Japan

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Okinawa, Japan

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Osaka, Japan

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Ōita, Japan

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Saga, Japan

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Saitama, Japan

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Shiga, Japan

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Shimane, Japan

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Shizuoka, Japan

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Tochigi, Japan

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Tokushima, Japan

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Tokyo, Japan

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Tottori, Japan

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Toyama, Japan

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Wakayama, Japan

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Yamagata, Japan

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Yamaguchi, Japan

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Yamanashi, Japan

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Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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 24, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations