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
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).
Investigators
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)