COPDNCT01221480
What Influences Patient Outcome in Obstructive Airway Disease?
An observational study of COPD, run by University of Dundee.
Trial summary
The aim of this observational study is to utilise the established record linkage data available in Tayside to investigate hospital admissions, exacerbations and mortality in COPD. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- COPD
- How many people
- 5,977 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Oct 2010
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients within NHS Tayside, UK
Who may be able to join
- Data collected through TARDIS database
Who cannot join
- History of asthma or malignancy. Less than 50 years of age
About this study
Official title: Beta-Blockers Reduce Mortality and Exacerbations When Added to Stepwise Inhaled Therapy for COPD Without Adverse Effects on Lung Function.
The aim of this observational study is to utilise the established record linkage data available in Tayside to investigate hospital admissions, exacerbations and mortality in COPD.
- Conditions
- COPD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Beta Blocker Use | Not described | |
| No beta blocker use | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality
All-cause Mortality
Measured: 3000 days
Secondary outcomes (2)
Hospital Admissions
Hospital Admissions
Measured: 3000 days
COPD exacerbations
COPD exacerbations
Measured: 3000 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 5,977 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221480
- Sponsor's protocol ID
- SHO002
- Status last verified
- Apr 2023
- First submitted
- 14 Oct 2010
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Short PM, Lipworth SI, Elder DH, Schembri S, Lipworth BJ. Effect of beta blockers in treatment of chronic obstructive pulmonary disease: a retrospective cohort study. BMJ. 2011 May 10;342:d2549. doi: 10.1136/bmj.d2549.
PubMed 21558357
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Blockers Reduce Mortality and Exacerbations When Added to Stepwise Inhaled Therapy for COPD Without Adverse Effects on Lung Function.
- ClinicalTrials.gov ID
- NCT01221480
- Acronym / sponsor ID
- SHO002
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,977 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Oct 2010 (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 aim of this observational study is to utilise the established record linkage data available in Tayside to investigate hospital admissions, exacerbations and mortality in COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta Blocker Use | – | – |
| No beta blocker use | – | – |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients within NHS Tayside, UK
Key inclusion criteria (1 listed)
- Data collected through TARDIS database
Key exclusion criteria (1 listed)
- History of asthma or malignancy. Less than 50 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause Mortality
Time frame: 3000 days
All-cause Mortality
2 secondary outcomes
Hospital Admissions
Time frame: 3000 days
COPD exacerbations
Time frame: 3000 days
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 Apr 2023.
- Results publication: PubMed 21558357Short PM, Lipworth SI, Elder DH, Schembri S, Lipworth BJ. Effect of beta blockers in treatment of chronic obstructive pulmonary disease: a retrospective cohort study. BMJ. 2011 May 10;342:d2549. doi: 10.1136/bmj.d2549.
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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 COPD, run by University of Dundee.
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 Apr 2023. 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?
All-cause Mortality (time frame: 3000 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01221480, which also lists 1 linked publication.
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 Apr 2023.