Pulmonary Disease, Chronic ObstructiveNCT02172495
Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Daily Practice
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Post-marketing surveillance to gather information regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium bromide
- How many people
- 4,700 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Oct 2003
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged at least 40 years with the symptoms of Chronic Obstructive Pulmonary Disease
Who cannot join
- Patients with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
About this study
Official title: Tolerability and Efficacy of Spiriva® 18 Micrograms in Patients With COPD in Daily Practice
Post-marketing surveillance to gather information regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium bromide
- 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.
Tiotropium bromideDrug
Also called Spiriva®
Tiotropium bromide 18 micrograms
| Study group | Role | What they receive |
|---|---|---|
| Symptoms of COPD | Patients with symptoms of COPD receiving Tiotropium bromide 18 micrograms Receives: Drug: Tiotropium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in breathlessness when walking/climbing stairs
Measured: Baseline, after 4 weeks
Change from baseline in breathlessness on physical exercise
Measured: Baseline, after 4 weeks
Change from baseline in breathlessness during everyday activities
Measured: Baseline, after 4 weeks
Change from baseline in breathlessness during housework
Measured: Baseline, after 4 weeks
Change from baseline in overall severity of the clinical picture
Measured: Baseline, after 4 weeks
Occurrence of Adverse Events
Measured: 4 weeks
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 startJun 2002
- Primary completionOct 2003
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,700 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
- NCT02172495
- Sponsor's protocol ID
- 205.278
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Efficacy of Spiriva® 18 Micrograms in Patients With COPD in Daily Practice
- ClinicalTrials.gov ID
- NCT02172495
- Acronym / sponsor ID
- 205.278
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,700 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Oct 2003 (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.
Post-marketing surveillance to gather information regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptoms of COPD | – | Drug: Tiotropium bromidePatients with symptoms of COPD receiving Tiotropium bromide 18 micrograms |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women aged at least 40 years with the symptoms of Chronic Obstructive Pulmonary Disease
Key exclusion criteria (1 listed)
- Patients with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
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 bromideAlso: Spiriva®Tiotropium bromide 18 micrograms | Drug | Symptoms of COPD |
Primary outcome
Change from baseline in breathlessness when walking/climbing stairs
Time frame: Baseline, after 4 weeks
Change from baseline in breathlessness on physical exercise
Time frame: Baseline, after 4 weeks
Change from baseline in breathlessness during everyday activities
Time frame: Baseline, after 4 weeks
Change from baseline in breathlessness during housework
Time frame: Baseline, after 4 weeks
Change from baseline in overall severity of the clinical picture
Time frame: Baseline, after 4 weeks
Occurrence of Adverse Events
Time frame: 4 weeks
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 31 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in breathlessness when walking/climbing stairs (time frame: Baseline, after 4 weeks). The study lists 6 primary outcomes in all. 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 31 Aug 2018.