Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Spiolto

• Registration Number: NCT02850978
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-01
• Study Start: 2016-08-23
• Primary Completion: 2018-10-30
• Study Completion: 2018-11-30
• Status Verified: 2019-11
• Results First Submitted: 2019-11-15
• Results First Submitted QC: 2019-11-15
• Last Update Submitted: 2019-11-15
• Results First Posted: 2019-12-06
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1335

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spiolto	Spiolto	Patient with COPD to received Spiolto

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Drug Reactions	From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.	Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as "Yes".

Secondary Outcome Measures

Name	Time	Method
Change of COPD Assessment Test (CAT) Score From Baseline to Week 12	Baseline and Week 12	The COPD Assessment Test™ (CAT) is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT questionnaire has the advantage of a reduced number of items and could be used to assess the effects of inhaled therapies. The CAT score was the sum of the values corresponding to the answers to the eight questions.