Pulmonary Disease, Chronic Obstructive
Conditions
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).
Interventions
DRUGTiotropium
Sponsors
Boehringer Ingelheim
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255.
Exclusion criteria
* Not applicable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and status of patients dead or alive at the predicted end of treatment date | Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia, New Zealand, United Kingdom
Outcome results
None listed