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NCT02196194 Clinical Trial

A Prescription-Event Monitoring (PEM) Study of Tiotropium

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:
A Prescription-Event Monitoring (PEM) Study of Tiotropium Based on Prescription Data Collected by the Prescription Pricing Authority (PPA) in England for Tiotropium (Spiriva®)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02196194
Other study ID # 205.290
Secondary ID
Status Completed
Phase N/A
First received July 18, 2014
Last updated July 18, 2014
Start date September 2002

Study information
Verified date July 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 13891
Est. completion date
Est. primary completion date August 2003
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients who were prescribed tiotropium

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Tiotropium

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary incidence density of events incidence density per 1000 patient-months of treatment up to sixth month of treatment No
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