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
- Registration Number
- NCT02172560
- Lead Sponsor
- Boehringer Ingelheim
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 441
- Patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255.
- Not applicable.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Premature withdrawal from tiotropium Tiotropium -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (19)
Boehringer Ingelheim Investigational Site 61503
🇦🇺Nedlands, Western Australia, Australia
Boehringer Ingelheim Investigational Site 61405
🇦🇺Perth, Western Australia, Australia
Boehringer Ingelheim Investigational Site 61502
🇦🇺Adelaide, South Australia, Australia
Boehringer Ingelheim Investigational Site 61501
🇦🇺Garran, Australian Capital Territory, Australia
Boehringer Ingelheim Investigational Site 61401
🇦🇺Woodsville South, South Australia, Australia
Boehringer Ingelheim Investigational Site 61403
🇦🇺Clayton, New South Wales, Australia
Boehringer Ingelheim Investigational Site 61402
🇦🇺Frankston, Victoria, Australia
Boehringer Ingelheim Investigational Site 61504
🇳🇿Otahuhu, New Zealand
Boehringer Ingelheim Investigational Site 61505
🇳🇿Hamilton, New Zealand
Boehringer Ingelheim Investigational Site 44409
🇬🇧Bristol, United Kingdom
Boehringer Ingelheim Investigational Site 44402
🇬🇧Birmingham, United Kingdom
Boehringer Ingelheim Investigational Site 44502
🇬🇧Devon, United Kingdom
Boehringer Ingelheim Investigational Site 44504
🇬🇧Hull, United Kingdom
Boehringer Ingelheim Investigational Site 44507
🇬🇧Isleworth, United Kingdom
Boehringer Ingelheim Investigational Site 44405
🇬🇧Swansea, United Kingdom
Boehringer Ingelheim Investigational Site 44506
🇬🇧Manchester, United Kingdom
Boehringer Ingelheim Investigational Site 44505
🇬🇧Torquay, United Kingdom
Boehringer Ingelheim Investigational Site 44403
🇬🇧Nottingham, United Kingdom
Boehringer Ingelheim Investigational Site 44404
🇬🇧Torquay, United Kingdom