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NCT01232335 Clinical Trial

Symbicort Turbuhaler 30/60 Specific Clinical Experience Investigation

Bronchial Asthma Clinical Trial

— ENSURE  

Official title:
Symbicort Turbuhaler 30/60 Specific Clinical Experience Investigation for Long-term Use

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01232335
Other study ID # D589IC00001
Secondary ID
Status Completed
Phase N/A
First received October 31, 2010
Last updated May 28, 2013
Start date January 2010
Est. completion date May 2013

Study information
Verified date May 2013
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 this study is to confirm the safety profile for long term treatment and maximize doses and the control status on bronchial asthma in daily clinical usage

Recruitment information / eligibility
Status Completed
Enrollment 1500
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients treated with Symbicort for the first time possibly at the higher dose due to bronchial asthma

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events Range of one year Yes
Secondary The level of asthma control under long-term use At the end of 24 weeks No
Secondary The level of asthma control under long-term use At the end of one year No
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