Clinical trial NCT02172560: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 441
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COPD who withdrew prematurely from the randomised treatment phases of studies 205.254 and 205.255

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: Number and status of patients dead or alive at the predicted end of treatment date
timeFrame: Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death
Secondary outcomes:
measure: Number and specification of patients on pulmonary medications and other pulmonary interventions
timeFrame: Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death
Other outcomes:
Locations:
city: Garran
country: Australia
facility: Boehringer Ingelheim Investigational Site 61501
state: Australian Capital Territory
city: Clayton
country: Australia
facility: Boehringer Ingelheim Investigational Site 61403
state: New South Wales
city: Adelaide
country: Australia
facility: Boehringer Ingelheim Investigational Site 61502
state: South Australia
city: Woodsville South
country: Australia
facility: Boehringer Ingelheim Investigational Site 61401
state: South Australia
city: Frankston
country: Australia
facility: Boehringer Ingelheim Investigational Site 61402
state: Victoria
city: Nedlands
country: Australia
facility: Boehringer Ingelheim Investigational Site 61503
state: Western Australia
city: Perth
country: Australia
facility: Boehringer Ingelheim Investigational Site 61405
state: Western Australia
city: Hamilton
country: New Zealand
facility: Boehringer Ingelheim Investigational Site 61505
city: Otahuhu
country: New Zealand
facility: Boehringer Ingelheim Investigational Site 61504
city: Birmingham
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 44402
city: Bristol
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 44409
city: Devon
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 44502
city: Hull
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 44504
city: Isleworth
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 44507
city: Manchester
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 44506
city: Nottingham
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 44403
city: Swansea
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 44405
city: Torquay
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 44404
city: Torquay
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 44505
Study officials:
References: