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Clinical Trials/NCT02172560
NCT02172560
Completed
Not Applicable

A Retrospective Collection of Vital Status and Pulmonary Medication Usage Data for Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Withdrew Prematurely From Either of Two One-Year Trials (205.254, 205.255) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler

Boehringer Ingelheim19 sites in 3 countries441 target enrollmentMarch 2007

Overview

Phase
Not Applicable
Intervention
Tiotropium
Conditions
Pulmonary Disease, Chronic Obstructive
Sponsor
Boehringer Ingelheim
Enrollment
441
Locations
19
Primary Endpoint
Number and status of patients dead or alive at the predicted end of treatment date
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The objectives were to collect information on vital status and pulmonary medication use at the predicted exit date for patients who participated in two one-year trials and withdrew prematurely. The primary objective was to ascertain the vital status (dead or alive) of these patients in the time interval between the patients' withdrawal from the trial and their predicted exit date (i.e: 48 weeks from first intake of randomised treatment + 30 days). The secondary objective was to collect information on classes of pulmonary medication and some other specified pulmonary interventions used by these prematurely discontinued patients at the time of their predicted exit date (i.e 48 weeks from the first intake of randomised treatment + 30 days) or at date of death (if this occurred during the time interval of interest, i.e 48 weeks from the first intake of randomised treatment + 30 days).

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
January 2008
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255.

Exclusion Criteria

  • Not applicable.

Arms & Interventions

Premature withdrawal from tiotropium

Intervention: Tiotropium

Outcomes

Primary Outcomes

Number and status of patients dead or alive at the predicted end of treatment date

Time Frame: Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death

Secondary Outcomes

  • Number and specification of patients on pulmonary medications and other pulmonary interventions(Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death)

Study Sites (19)

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