A Collection of Vital Status and Pulmonary Medication Usage Data for Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Withdrew Prematurely From Tiotropium Inhalation Solution Delivered by the Respimat Inhaler

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium

Study type: Observational

Funder types: Industry

Identifiers

NCT02172560

205.392

Details and patient eligibility

About

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).

Enrollment: 441 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Not applicable.

Trial design

441 participants in 1 patient group

Premature withdrawal from tiotropium

Treatment:

Drug: Tiotropium