ClinicalTrials.gov
ClinicalTrials.gov Menu

Oxis 9mcg Turbuhaler Clinical Experience Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01749462
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

Condition or disease
Chronic Obstructive Pulmonary Disease

Detailed Description:
Oxis 9mcg Turbuhaler Clinical Experience Investigation

Study Type : Observational
Actual Enrollment : 398 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxis 9mcg Turbuhaler Clinical Experience Investigation
Study Start Date : February 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Oxis



Primary Outcome Measures :
  1. Adverse event incidence [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01749462     History of Changes
Other Study ID Numbers: D5127L00001
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016

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