A Prescription-Event Monitoring (PEM) Study of Tiotropium

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium

• Registration Number: NCT02196194
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2003-08
• Status Verified: 2014-07
• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-18
• Last Update Submitted: 2014-07-18
• Study First Posted: 2014-07-21
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13891

Inclusion Criteria

• patients who were prescribed tiotropium

Exclusion Criteria

• not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tiotropium	Tiotropium	-

Primary Outcome Measures

Name	Time	Method
incidence density of events	up to sixth month of treatment	incidence density per 1000 patient-months of treatment