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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
205.392
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Tiotropium

Premature withdrawal from tiotropium -


Treatment: Drugs: Tiotropium
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and status of patients dead or alive at the predicted end of treatment date
Timepoint [1] 0 0
Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death
Secondary outcome [1] 0 0
Number and specification of patients on pulmonary medications and other pulmonary interventions
Timepoint [1] 0 0
Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death

Eligibility
Key inclusion criteria
- Patients who withdrew prematurely from the randomised treatment phase of studies
205.254 and 205.255.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not applicable.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
441
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Boehringer Ingelheim Investigational Site 61501 - Garran
Recruitment hospital [2] 0 0
Boehringer Ingelheim Investigational Site 61403 - Clayton
Recruitment hospital [3] 0 0
Boehringer Ingelheim Investigational Site 61502 - Adelaide
Recruitment hospital [4] 0 0
Boehringer Ingelheim Investigational Site 61401 - Woodsville South
Recruitment hospital [5] 0 0
Boehringer Ingelheim Investigational Site 61402 - Frankston
Recruitment hospital [6] 0 0
Boehringer Ingelheim Investigational Site 61503 - Nedlands
Recruitment hospital [7] 0 0
Boehringer Ingelheim Investigational Site 61405 - Perth
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Woodsville South
Recruitment postcode(s) [5] 0 0
- Frankston
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment postcode(s) [7] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton
Country [2] 0 0
New Zealand
State/province [2] 0 0
Otahuhu
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Birmingham
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Bristol
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Devon
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Hull
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Isleworth
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Manchester
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Nottingham
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Swansea
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Torquay

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02172560
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02172560