Oxis 9mcg Turbuhaler Clinical Experience Investigation

February 9, 2016 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Detailed Description

Oxis 9mcg Turbuhaler Clinical Experience Investigation

Study Type

Observational

Enrollment (Actual)

398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • D5127l00001
      • Aichi, D5127l00001, Japan
        • Research Site
      • Akita, D5127l00001, Japan
        • Research Site
      • Aomori, D5127l00001, Japan
        • Research Site
      • Chiba, D5127l00001, Japan
        • Research Site
      • Fukuoka, D5127l00001, Japan
        • Research Site
      • Fukushima, D5127l00001, Japan
        • Research Site
      • Gifu, D5127l00001, Japan
        • Research Site
      • Gunma, D5127l00001, Japan
        • Research Site
      • Hiroshima, D5127l00001, Japan
        • Research Site
      • Hokkaido, D5127l00001, Japan
        • Research Site
      • Hyogo, D5127l00001, Japan
        • Research Site
      • Ibaraki, D5127l00001, Japan
        • Research Site
      • Ishikawa, D5127l00001, Japan
        • Research Site
      • Iwate, D5127l00001, Japan
        • Research Site
      • Kagawa, D5127l00001, Japan
        • Research Site
      • Kagoshima, D5127l00001, Japan
        • Research Site
      • Kanagawa, D5127l00001, Japan
        • Research Site
      • Kochi, D5127l00001, Japan
        • Research Site
      • Kyoto, D5127l00001, Japan
        • Research Site
      • Mie, D5127l00001, Japan
        • Research Site
      • Miyagi, D5127l00001, Japan
        • Research Site
      • Miyazaki, D5127l00001, Japan
        • Research Site
      • Nagano, D5127l00001, Japan
        • Research Site
      • Nagasaki, D5127l00001, Japan
        • Research Site
      • Nara, D5127l00001, Japan
        • Research Site
      • Niigata, D5127l00001, Japan
        • Research Site
      • Oita, D5127l00001, Japan
        • Research Site
      • Okayama, D5127l00001, Japan
        • Research Site
      • Okinawa, D5127l00001, Japan
        • Research Site
      • Osaka, D5127l00001, Japan
        • Research Site
      • Saitama, D5127l00001, Japan
        • Research Site
      • Shiga, D5127l00001, Japan
        • Research Site
      • Shimane, D5127l00001, Japan
        • Research Site
      • Shizuoka, D5127l00001, Japan
        • Research Site
      • Tochigi, D5127l00001, Japan
        • Research Site
      • Tokushima, D5127l00001, Japan
        • Research Site
      • Tokyo, D5127l00001, Japan
        • Research Site
      • Toyama, D5127l00001, Japan
        • Research Site
      • Yamagata, D5127l00001, Japan
        • Research Site
      • Yamaguchi, D5127l00001, Japan
        • Research Site
      • Yamanashi, D5127l00001, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

- 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Oxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse event incidence
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 13, 2012

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5127L00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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