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NCT01749462 Clinical Trial

Oxis 9mcg Turbuhaler Clinical Experience Investigation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Oxis 9mcg Turbuhaler Clinical Experience Investigation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01749462
Other study ID # D5127L00001
Secondary ID
Status Completed
Phase N/A
First received December 12, 2012
Last updated February 9, 2016
Start date February 2013
Est. completion date July 2015

Study information
Verified date February 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 ADR development and the contributing factors possibly having an impact on the safety under the post-marketing actual use of Oxis 9 mcg Turbuhaler.

Description:

Oxis 9mcg Turbuhaler Clinical Experience Investigation

Recruitment information / eligibility
Status Completed
Enrollment 398
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site 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

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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