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A Prescription-Event Monitoring (PEM) Study of Tiotropium

NCT ID: NCT02196194

Last Updated: 2014-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13891 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-09-30

Brief Summary

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This prescription-event monitoring study was based upon 'event' monitoring and so capable of identifying signals of events that might be associated with the use of tiotropium, which none of the participating general practitioners (GPs) suspected to be an adverse drug reaction. The methodology of this study readily permits follow up of specific events and the obtaining of additional data as appropriate.

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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

RETROSPECTIVE

Study Groups

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tiotropium

Tiotropium

Intervention Type DRUG

Interventions

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Tiotropium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients who were prescribed tiotropium

Exclusion Criteria

* not applicable
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

Other Identifiers

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205.290

Identifier Type: -

Identifier Source: org_study_id

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