NCT Number: 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
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).
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Boehringer Ingelheim Investigational Site 61501, Garran, Australian Capital Territory, Australia
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255.
Exclusion criteria
- Not applicable.
Treatment and study plan
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
Time frame: Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study 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
Important dates
- Study start
- 2007
- Primary completion
- 2008
- First posted
- Jun 24, 2014
- Registry last updated
- Nov 18, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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