Oxis 9mcg Turbuhaler Clinical Experience Investigation

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01749462
• Lead Sponsor: 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.

Detailed Description

Oxis 9mcg Turbuhaler Clinical Experience Investigation

Study Timeline

• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-13
• Study Start: 2013-02
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse event incidence	12 weeks

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, D5127l00001, Japan