Pulmonary Disease, Chronic ObstructiveNCT02172521
Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Proven Hyperinflation
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Primary objective of this observational study was to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) 18 microgram on the health-related quality of life and physical functioning in patients with chronic obstructive pulmonary disease (COPD) and demonstrated hyperinflation. 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 bromide
- Type of treatment
- Pill or oral medicine
- How many people
- 1,536 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Oct 2006
- 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
Who may be able to join
- Women and men with diagnosis of chronic obstructive pulmonary disease (COPD) with a thoracic gas volume (TGV) > = 120% as measured by body plethysmography
- Only patients who have not yet been treated with Spiriva® 18 micrograms can be included in the study.
Who cannot join
- Patients who presenting the general and specific contraindications mentioned in the Patient Information and Prescribing Information
About this study
Official title: Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With COPD and Proven Hyperinflation
- Primary objective of this observational study was to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) 18 microgram on the health-related quality of life and physical functioning in patients with chronic obstructive pulmonary disease (COPD) and demonstrated hyperinflation.
- Secondary objective was to obtain safety data regarding adverse events.
- 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 bromide18 micrograms by oral inhalation (1 x daily) with the HandiHaler®
| Study group | Role | What they receive |
|---|---|---|
| COPD and proven hyperinflation | Patients with COPD and proven hyperinflation receiving tiotropium bromide 18 microgram Receives: Drug: Tiotropium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline for assessment of the health-related euro quality of life 5 dimensions questionnaire (EQ-5D) time trade off (TTO) score
Measured: At baseline (visit 1) and after 4 weeks (visit 2)
Change from baseline for assessment of the health-related EQ-5D questionnaire linear rating scale
Measured: At baseline (visit 1) and after 4 weeks (visit 2)
Change from baseline for assessment of physical functioning in every day life (PF-10)
Measured: At baseline (visit 1) and after 4 weeks (visit 2)
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 startJan 2006
- Primary completionOct 2006
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
- 1,536 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
- NCT02172521
- Sponsor's protocol ID
- 205.320
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With COPD and Proven Hyperinflation
- ClinicalTrials.gov ID
- NCT02172521
- Acronym / sponsor ID
- 205.320
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,536 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Oct 2006 (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.
- Primary objective of this observational study was to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) 18 microgram on the health-related quality of life and physical functioning in patients with chronic obstructive pulmonary disease (COPD) and demonstrated hyperinflation.
- Secondary objective was to obtain safety data regarding adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD and proven hyperinflation | – | Drug: Tiotropium bromidePatients with COPD and proven hyperinflation receiving tiotropium bromide 18 microgram |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women and men with diagnosis of chronic obstructive pulmonary disease (COPD) with a thoracic gas volume (TGV) > = 120% as measured by body plethysmography
- Only patients who have not yet been treated with Spiriva® 18 micrograms can be included in the study.
Key exclusion criteria (1 listed)
- Patients who presenting the general and specific contraindications mentioned in the Patient Information and Prescribing 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 bromide18 micrograms by oral inhalation (1 x daily) with the HandiHaler® | Drug | COPD and proven hyperinflation |
Primary outcome
Change from baseline for assessment of the health-related euro quality of life 5 dimensions questionnaire (EQ-5D) time trade off (TTO) score
Time frame: At baseline (visit 1) and after 4 weeks (visit 2)
Change from baseline for assessment of the health-related EQ-5D questionnaire linear rating scale
Time frame: At baseline (visit 1) and after 4 weeks (visit 2)
Change from baseline for assessment of physical functioning in every day life (PF-10)
Time frame: At baseline (visit 1) and after 4 weeks (visit 2)
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 24 Jun 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.
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 2 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 24 Jun 2014. 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 for assessment of the health-related euro quality of life 5 dimensions questionnaire (EQ-5D) time trade off (TTO) score (time frame: At baseline (visit 1) and after 4 weeks (visit 2)). The study lists 3 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 24 Jun 2014.