Pulmonary Disease, Chronic ObstructiveNCT02172560
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
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 19 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium
- How many people
- 441 participants
- Where
- 19 sitesin 3 countries
- Study dates
- Mar 2007to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with COPD who withdrew prematurely from the randomised treatment phases of studies 205.254 and 205.255
Who may be able to join
- Patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255.
Who cannot join
- Not applicable.
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
United Kingdom10 sites
Boehringer Ingelheim Investigational Site 44402
Birmingham
Boehringer Ingelheim Investigational Site 44409
Bristol
Boehringer Ingelheim Investigational Site 44502
Devon
Boehringer Ingelheim Investigational Site 44504
Hull
Boehringer Ingelheim Investigational Site 44507
Isleworth
Boehringer Ingelheim Investigational Site 44506
Manchester
Boehringer Ingelheim Investigational Site 44403
Nottingham
Boehringer Ingelheim Investigational Site 44405
Swansea
Boehringer Ingelheim Investigational Site 44404
Torquay
Boehringer Ingelheim Investigational Site 44505
Torquay
Australia7 sites
Boehringer Ingelheim Investigational Site 61502
Adelaide, South Australia
Boehringer Ingelheim Investigational Site 61403
Clayton, New South Wales
Boehringer Ingelheim Investigational Site 61402
Frankston, Victoria
Boehringer Ingelheim Investigational Site 61501
Garran, Australian Capital Territory
Boehringer Ingelheim Investigational Site 61503
Nedlands, Western Australia
Boehringer Ingelheim Investigational Site 61405
Perth, Western Australia
Boehringer Ingelheim Investigational Site 61401
Woodsville South, South Australia
New Zealand2 sites
Boehringer Ingelheim Investigational Site 61505
Hamilton
Boehringer Ingelheim Investigational Site 61504
Otahuhu
About this study
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
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).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiotropiumDrug
| Study group | Role | What they receive |
|---|---|---|
| Premature withdrawal from tiotropium | Not described Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and status of patients dead or alive at the predicted end of treatment date
Measured: Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death
Secondary outcomes (1)
Number and specification of patients on pulmonary medications and other pulmonary interventions
Measured: Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startMar 2007
- Primary completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172560
- Sponsor's protocol ID
- 205.392
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 18 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02172560
- Acronym / sponsor ID
- 205.392
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature withdrawal from tiotropium | – | Drug: Tiotropium |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with COPD who withdrew prematurely from the randomised treatment phases of studies 205.254 and 205.255
Key inclusion criteria (1 listed)
- Patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiotropium | Drug | Premature withdrawal from tiotropium |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 19 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United Kingdom, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.