A Prescription-Event Monitoring (PEM) Study of Tiotropium

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02196194

Enrollment

13891

Registered

2014-07-21

Start date

2002-09-30

Completion date

Unknown

Last updated

2014-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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.

Interventions

DRUGTiotropium

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* patients who were prescribed tiotropium

Exclusion criteria

* not applicable

Design outcomes

Primary

Measure	Time frame	Description
incidence density of events	up to sixth month of treatment	incidence density per 1000 patient-months of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026