Chronic Obstructive Pulmonary DiseaseNCT01013922
A Descriptive Study to Explore Certain Characteristics of Patients at Risk for Chronic Obstructive Pulmonary Disease (COPD) in a Primary Care Setting
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 23 sites in Sweden.
Trial summary
The purpose of this study is to explore if certain characteristics, easily detected within a regular primary care setting, may indicate that a patient at risk for COPD (45 ≤ age ≤ 80 years and a smoking history of ≥ 15 pack years) is prone to have a diagnosis of COPD according to Medical Products Agency guidelines. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 309 participants
- Where
- 23 sitesSweden
- Study dates
- Oct 2009to Mar 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patients with a history of smoking one pack of cigarettes per day for 15 years or more
Who cannot join
- Known Chronic Obstructive Pulmonary Disease
- Known severe cardiovascular disease
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Sweden23 sites
Research Site
Alingsås
Research Site
Arvidsjaur
Research Site
Askim
Research Site
Åtvidaberg
Research Site
Bromma
Research Site
Eslöv
Research Site
Falun
Research Site
Gagnef
Research Site
Gothenburg
Research Site
Hagfors
Research Site
Helsingborg
Research Site
Hisings Kärra
Research Site
Höllviken
Research Site
Järpen
Research Site
Karlshamn
Research Site
Karlskrona
Research Site
Kil
Research Site
Limhamn
Research Site
Linköping
Research Site
Luleå
Research Site
Stockholm
Research Site
Timrå
Research Site
Värnamo
About this study
Official title: A Descriptive Study to Explore Certain Characteristics of Patients at Risk for COPD in a Primary Care Setting
The purpose of this study is to explore if certain characteristics, easily detected within a regular primary care setting, may indicate that a patient at risk for COPD (45 ≤ age ≤ 80 years and a smoking history of ≥ 15 pack years) is prone to have a diagnosis of COPD according to Medical Products Agency guidelines.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, COPD-6, Spirometry, VC, FEV, FEV1
- 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 |
|---|---|---|
| No treatment | Patients with a smoking history of 15 pack years or more. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patients will test their lung function with a COPD-6 screener for COPD and compare with regular spirometry. Medical records will be checked for health care contacts with respiratory diagnosis during the last 24 months prior to the study visit.
Measured: There will only be one visit in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionMar 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 Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Björn Tilling, Principal investigator, Åtvidabergs vårdcentralGeorgios Stratelis, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013922
- Sponsor's protocol ID
- NIS-RSE-DUM-2008/1
- Status last verified
- Nov 2010
- First submitted
- 13 Nov 2009
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Thorn J, Tilling B, Lisspers K, Jorgensen L, Stenling A, Stratelis G. Improved prediction of COPD in at-risk patients using lung function pre-screening in primary care: a real-life study and cost-effectiveness analysis. Prim Care Respir J. 2012 Jun;21(2):159-66. doi: 10.4104/pcrj.2011.00104.
PubMed 22270480
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study to Explore Certain Characteristics of Patients at Risk for COPD in a Primary Care Setting
- ClinicalTrials.gov ID
- NCT01013922
- Acronym / sponsor ID
- NIS-RSE-DUM-2008/1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, COPD-6, Spirometry, VC, FEV, FEV1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Nov 2009 (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 purpose of this study is to explore if certain characteristics, easily detected within a regular primary care setting, may indicate that a patient at risk for COPD (45 ≤ age ≤ 80 years and a smoking history of ≥ 15 pack years) is prone to have a diagnosis of COPD according to Medical Products Agency guidelines.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | –Patients with a smoking history of 15 pack years or more. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- Patients with a history of smoking one pack of cigarettes per day for 15 years or more
Key exclusion criteria (2 listed)
- Known Chronic Obstructive Pulmonary Disease
- Known severe cardiovascular disease
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
The patients will test their lung function with a COPD-6 screener for COPD and compare with regular spirometry. Medical records will be checked for health care contacts with respiratory diagnosis during the last 24 months prior to the study visit.
Time frame: There will only be one visit in the study
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 19 Nov 2010.
- Derived from this study: PubMed 22270480Thorn J, Tilling B, Lisspers K, Jorgensen L, Stenling A, Stratelis G. Improved prediction of COPD in at-risk patients using lung function pre-screening in primary care: a real-life study and cost-effectiveness analysis. Prim Care Respir J. 2012 Jun;21(2):159-66. doi: 10.4104/pcrj.2011.00104.
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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.
Björn Tilling principal investigator
Åtvidabergs vårdcentral
Georgios Stratelis study director
AstraZeneca
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 23 sites in Sweden.
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 2 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 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Sweden. 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?
The patients will test their lung function with a COPD-6 screener for COPD and compare with regular spirometry. Medical records will be checked for health care contacts with respiratory diagnosis during the last 24 months prior to the study visit. (time frame: There will only be one visit in the study). 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 NCT01013922, 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 19 Nov 2010.