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Oxis 9mcg Turbuhaler Clinical Experience Investigation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01749462
First received: December 12, 2012
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
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.

Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxis 9mcg Turbuhaler Clinical Experience Investigation

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse event incidence [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 398
Study Start Date: February 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Detailed Description:
Oxis 9mcg Turbuhaler Clinical Experience Investigation
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749462

Locations
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, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Shigeru Yoshida, MD Astrazeneca KK
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01749462     History of Changes
Other Study ID Numbers: D5127L00001 
Study First Received: December 12, 2012
Last Updated: February 9, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
chronic obstructive pulmonary disease,
COPD,
Oxis,

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on December 09, 2016