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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02172560
Registration number
NCT02172560
Ethics application status
Date submitted
20/06/2014
Date registered
24/06/2014
Date last updated
18/11/2014
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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205.392
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Premature withdrawal from tiotropium -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number and status of patients dead or alive at the predicted end of treatment date
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Assessment method [1]
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Timepoint [1]
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Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death
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Secondary outcome [1]
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Number and specification of patients on pulmonary medications and other pulmonary interventions
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Assessment method [1]
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Timepoint [1]
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Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death
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Eligibility
Key inclusion criteria
* Patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Not applicable.
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
441
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
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Recruitment hospital [1]
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Boehringer Ingelheim Investigational Site 61501 - Garran
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Recruitment hospital [2]
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Boehringer Ingelheim Investigational Site 61403 - Clayton
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Recruitment hospital [3]
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Boehringer Ingelheim Investigational Site 61502 - Adelaide
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Recruitment hospital [4]
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Boehringer Ingelheim Investigational Site 61401 - Woodsville South
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Recruitment hospital [5]
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Boehringer Ingelheim Investigational Site 61402 - Frankston
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Recruitment hospital [6]
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Boehringer Ingelheim Investigational Site 61503 - Nedlands
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Recruitment hospital [7]
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Boehringer Ingelheim Investigational Site 61405 - Perth
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Recruitment postcode(s) [1]
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- Garran
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Recruitment postcode(s) [2]
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- Clayton
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Recruitment postcode(s) [3]
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- Adelaide
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Recruitment postcode(s) [4]
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- Woodsville South
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Recruitment postcode(s) [5]
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- Frankston
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Recruitment postcode(s) [6]
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- Nedlands
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Recruitment postcode(s) [7]
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- Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Hamilton
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Country [2]
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New Zealand
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State/province [2]
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Otahuhu
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United Kingdom
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Birmingham
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Country [4]
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United Kingdom
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Bristol
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Country [5]
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United Kingdom
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Devon
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Country [6]
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United Kingdom
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State/province [6]
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Hull
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Country [7]
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United Kingdom
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State/province [7]
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Isleworth
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Country [8]
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United Kingdom
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State/province [8]
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Manchester
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Country [9]
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United Kingdom
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Nottingham
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Country [10]
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United Kingdom
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Swansea
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Country [11]
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United Kingdom
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State/province [11]
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Torquay
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT02172560
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02172560
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