NCT01749462

Brief Summary

The purpose of the investigation is to confirm the ADR development and the contributing factors possibly having an impact on the safety under the post-marketing actual use of Oxis 9 mcg Turbuhaler.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
398

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

41 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

December 12, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

2.4 years

First QC Date

December 12, 2012

Last Update Submit

February 9, 2016

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease,COPD,Oxis,

Outcome Measures

Primary Outcomes (1)

  • Adverse event incidence

    12 weeks

Study Arms (1)

Oxis

Eligibility Criteria

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

Patients treated with Oxis for the first time due to 'relief of various symptoms associated with airway obstructive disorders of chronic obstructive pulmonary disease (Chronic bronchitis, Pulmonary emphysema), which is the indication of this drug.

You may qualify if:

  • \- Patients treated with Oxis for the first time due to 'relief of various symptoms associated with airway obstructive disorders of chronic obstructive pulmonary disease (Chronic bronchitis, Pulmonary emphysema), which is the indication of this drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Research Site

Aichi, D5127l00001, Japan

Location

Research Site

Akita, D5127l00001, Japan

Location

Research Site

Aomori, D5127l00001, Japan

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Chiba, D5127l00001, Japan

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Fukuoka, D5127l00001, Japan

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Fukushima, D5127l00001, Japan

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Gifu, D5127l00001, Japan

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Gunma, D5127l00001, Japan

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Hiroshima, D5127l00001, Japan

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Hokkaido, D5127l00001, Japan

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Hyōgo, D5127l00001, Japan

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Ibaraki, D5127l00001, Japan

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Ishikawa, D5127l00001, Japan

Location

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Kagawa, D5127l00001, Japan

Location

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Kagoshima, D5127l00001, Japan

Location

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Kanagawa, D5127l00001, Japan

Location

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Kochi, D5127l00001, Japan

Location

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Kyoto, D5127l00001, Japan

Location

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Mie, D5127l00001, Japan

Location

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Miyagi, D5127l00001, Japan

Location

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Miyazaki, D5127l00001, Japan

Location

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Nagano, D5127l00001, Japan

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Nagasaki, D5127l00001, Japan

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Nara, D5127l00001, Japan

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Niigata, D5127l00001, Japan

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Numakunai, D5127l00001, Japan

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Okayama, D5127l00001, Japan

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Okinawa, D5127l00001, Japan

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Osaka, D5127l00001, Japan

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Ōita, D5127l00001, Japan

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Saitama, D5127l00001, Japan

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Shiga, D5127l00001, Japan

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Shimane, D5127l00001, Japan

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Shizuoka, D5127l00001, Japan

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Tochigi, D5127l00001, Japan

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Research Site

Tokushima, D5127l00001, Japan

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Tokyo, D5127l00001, Japan

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Research Site

Toyama, D5127l00001, Japan

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Research Site

Yamagata, D5127l00001, Japan

Location

Research Site

Yamaguchi, D5127l00001, Japan

Location

Research Site

Yamanashi, D5127l00001, Japan

Location

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

December 12, 2012

First Posted

December 13, 2012

Study Start

February 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations

JP(41)