Clinical Experience Investigation of Symbicort Turbuhaler as Maintenance Therapy and Reliever Therapy

July 15, 2016 updated by: AstraZeneca

Symbicort Turbuhaler 30/60 Clinical Experience Investigation for Treatment With Symbicort as Maintenance Therapy and as Needed in Response to Symptoms

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Symbicort Turbuhaler 30/60 Clinical Experience Investigation for treatment with Symbicort as maintenance therapy and as needed in response to symptoms

Study Type

Observational

Enrollment (Actual)

2409

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
    • D589ll00001
      • Aichi, D589ll00001, Japan
        • Research Site
      • Akita, D589ll00001, Japan
        • Research Site
      • Aomori, D589ll00001, Japan
        • Research Site
      • Chiba, D589ll00001, Japan
        • Research Site
      • Ehime, D589ll00001, Japan
        • Research Site
      • Fukui, D589ll00001, Japan
        • Research Site
      • Fukuoka, D589ll00001, Japan
        • Research Site
      • Fukushima, D589ll00001, Japan
        • Research Site
      • Gifu, D589ll00001, Japan
        • Research Site
      • Gunma, D589ll00001, Japan
        • Research Site
      • Hiroshima, D589ll00001, Japan
        • Research Site
      • Hokkaido, D589ll00001, Japan
        • Research Site
      • Hyogo, D589ll00001, Japan
        • Research Site
      • Ibaraki, D589ll00001, Japan
        • Research Site
      • Ishikawa, D589ll00001, Japan
        • Research Site
      • Iwate, D589ll00001, Japan
        • Research Site
      • Kagawa, D589ll00001, Japan
        • Research Site
      • Kagoshima, D589ll00001, Japan
        • Research Site
      • Kanagawa, D589ll00001, Japan
        • Research Site
      • Kochi, D589ll00001, Japan
        • Research Site
      • Kumamoto, D589ll00001, Japan
        • Research Site
      • Kyoto, D589ll00001, Japan
        • Research Site
      • Mie, D589ll00001, Japan
        • Research Site
      • Miyagi, D589ll00001, Japan
        • Research Site
      • Miyazaki, D589ll00001, Japan
        • Research Site
      • Nagano, D589ll00001, Japan
        • Research Site
      • Nagasaki, D589ll00001, Japan
        • Research Site
      • Nara, D589ll00001, Japan
        • Research Site
      • Niigata, D589ll00001, Japan
        • Research Site
      • Oita, D589ll00001, Japan
        • Research Site
      • Okayama, D589ll00001, Japan
        • Research Site
      • Okinawa, D589ll00001, Japan
        • Research Site
      • Osaka, D589ll00001, Japan
        • Research Site
      • Saga, D589ll00001, Japan
        • Research Site
      • Saitama, D589ll00001, Japan
        • Research Site
      • Shiga, D589ll00001, Japan
        • Research Site
      • Shimane, D589ll00001, Japan
        • Research Site
      • Shizuoka, D589ll00001, Japan
        • Research Site
      • Tochigi, D589ll00001, Japan
        • Research Site
      • Tokushima, D589ll00001, Japan
        • Research Site
      • Tokyo, D589ll00001, Japan
        • Research Site
      • Tottori, D589ll00001, Japan
        • Research Site
      • Toyama, D589ll00001, Japan
        • Research Site
      • Wakayama, D589ll00001, Japan
        • Research Site
      • Yamagata, D589ll00001, Japan
        • Research Site
      • Yamaguchi, D589ll00001, Japan
        • Research Site
      • Yamanashi, D589ll00001, 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 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

Description

Inclusion Criteria:

  • 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

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
Symbicort

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

November 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 19, 2012

First Submitted That Met QC Criteria

October 19, 2012

First Posted (Estimate)

October 22, 2012

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D589LL00001

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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