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

NCT ID: NCT02850978

Last Updated: 2019-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-23

Study Completion Date

2018-11-30

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spiolto

Patient with COPD to received Spiolto

Spiolto

Intervention Type DRUG

Interventions

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Spiolto

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Multiple Locations, , Japan

Site Status

Countries

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Germany Japan

References

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Sato A, Miyazaki A, Nakamura S. Effectiveness of Tiotropium/Olodaterol in the Real World: A Post Hoc Subgroup Analysis After the First Year of Use. Adv Ther. 2022 Oct;39(10):4692-4706. doi: 10.1007/s12325-022-02268-1. Epub 2022 Aug 10.

Reference Type DERIVED
PMID: 35948844 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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1237.34

Identifier Type: -

Identifier Source: org_study_id