Specific Use-result Surveillance of Spiriva Respimat in Asthmatics

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

359 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-01

Study Completion Date

2017-09-28

Brief Summary

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The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.

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Detailed Description

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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

Patients with severe persistent asthma

Spiriva

Intervention Type DRUG

60 puffs

Interventions

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Spiriva

60 puffs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with severe 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 (Inhaled corticosteroids) treatment.

Exclusion Criteria

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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No