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

Boehringer Ingelheim1,335 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,335

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

SpioltoDRUG

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion criteria: * Patients who have been diagnosed with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) by physician and need relief of various symptoms associated with Long Acting Beta2 Agonist (LABA) or Long Acting Muscarinic Antagonist (LAMA). * Patients who are prescribed Tio+Olo FDC 5µg/5µg for the first time Exclusion criteria: * Patients who have been registered once in this study (i.e., re-entry of patients is not allowed). * Patients who are participating in a registry or clinical trial. * Patients who have a contraindication to Tio+Olo FDC 5µg/5µg defined in the package insert for Tio+Olo FDC 5µg/5µg.

Locations (1)

Unnamed facility

Multiple Locations, Japan

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Drug Reactions

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".

Time frame: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.

Secondary Outcomes

Change of COPD Assessment Test (CAT) Score From Baseline to 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.

Time frame: Baseline and Week 12

Data from ClinicalTrials.gov

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