Specific Use-Result of Spiriva Respimat® in Asthmatics

NCT ID: NCT03188120

Last Updated: 2019-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

193 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-04

Study Completion Date

2018-11-08

Brief Summary

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The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use

Detailed Description

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The study is Post-Marketing Surveillance on the Long-Term Use of Spiriva Respimat in Japanese patients with mild to moderate persistent asthma. The patient population who receive Spiriva Respimat and the safety profile is not expected to change. This study can investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spiriva Respimat group

Spiriva Respimat

Intervention Type DRUG

Drug

Interventions

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Spiriva Respimat

Drug

Intervention Type DRUG

Other Intervention Names

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FORVENT, SPIRIVA, SRIVASSO

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with mild to moderate persistent bronchial asthma
* Patient aged ≥ 15 years
* Patients who are naive to Spiriva Respimat and receive Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least ICS treatment.

Exclusion Criteria

* Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat
* Patients who have been enrolled in this study before.
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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Yukako Ogi

Role: STUDY_CHAIR

[email protected]

Locations

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Nippon Boehringer Ingelheim Co., Ltd

Tokyo, , Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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0205-0536

Identifier Type: -

Identifier Source: org_study_id

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