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NCT01711840 Clinical Trial

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

Bronchial Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01711840
Other study ID # D589LL00001
Secondary ID
Status Completed
Phase N/A
First received October 19, 2012
Last updated July 15, 2016
Start date November 2012
Est. completion date August 2015

Study information
Verified date July 2016
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 2409
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site 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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse event incidence 12 weeks Yes
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