CClinicalTrials.gg
CompletedNCT02196194Updated Jul 21, 2014

A Prescription-Event Monitoring (PEM) Study of Tiotropium

An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed. Per ClinicalTrials.gov, last updated 2014-07-21.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
13,891
Sex
All
01

Study 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.

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Conditions studied

  • Pulmonary Disease, Chronic Obstructive
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 13,891 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated with tiotropium

Inclusion criteria

  • patients who were prescribed tiotropium

Exclusion criteria

Exclusion Criteria:

  • not applicable
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
13,891 participants (actual)
Patient registry
No

Groups and cohorts

  • tiotropium

    Drug: Tiotropium

Interventions

  • DrugTiotropium
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What researchers measure

Primary outcomes

  1. incidence density of events

    incidence density per 1000 patient-months of treatment

    Time frame: up to sixth month of treatment

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02196194
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 21, 2014
Start date
Sep 2002
Primary completion
Aug 2003
Last update
Jul 21, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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