COPDKOSMOSNCT00772733
A Project Ensuring Quality and Cooperation in the Chronic Obstructive Pulmonary Disease (COPD) Treatment
An observational study of COPD and Chronic Diseases, run by AstraZeneca at 11 sites in Denmark.
Trial summary
The purpose of this study is to ensure the quality of the COPD treatment in primary care by implementing planned follow-up visits, where the disease condition is evaluated and optimised in accordance with the national COPD recommendations. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- COPD, Chronic Diseases
- How many people
- 936 participants
- Where
- 11 sitesDenmark
- Study dates
- Oct 2008to Dec 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed patients with COPD, verified by spirometry in general practise and/or municipalities.
Who may be able to join
- COPD diagnose, verified by spirometry
- Having given informed consent
Who cannot join
- -
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Denmark11 sites
Research Site
Aalborg
Research Site
Aarhus, Arhus
Research Site
Bjerringbro, Viborg
Research Site
Klarup
Research Site
Møldrup, Viborg
Research Site
Ørum
Research Site
Skals, Viborg
Research Site
Skive
Research Site
Spøttrup
Research Site
Stoholm
Research Site
Viborg
About this study
The purpose of this study is to ensure the quality of the COPD treatment in primary care by implementing planned follow-up visits, where the disease condition is evaluated and optimised in accordance with the national COPD recommendations. If relevant the general practitioner (GP) will refer patients to COPD rehabilitation conducted by relevant municipality rehabilitation teams. Secondarily the purpose is to improve collaboration and communication between the local hospital pulmonologist, GPs and the municipality rehabilitation team
- Conditions
- COPD, Chronic Diseases
- Keywords
- Quality assurance, rehabilitation, chronic care model, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Control visits at General practitioners
Measured: 6-12 months
Lung function measured by spirometry
Measured: 6-12 months
Secondary outcomes (3)
Dyspnoea on MRC scale
Measured: 6-12 months
Smoking status
Measured: 6-12 months
Rehabilitation completed in the municipality rehabilitation team
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Time perspective
- Prospective
- Enrolment
- 936 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Skov Jensen, MD, Study chair, Region Hospital Viborg, DKTina Brandt Sorensen, MD, Study chair, Region Hospital Horsens, DKOve Grann, Principal investigator, Aalborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772733
- Sponsor's protocol ID
- NIS-RDK-DUM-2007/1
- Acronym
- KOSMOS
- Status last verified
- Feb 2011
- First submitted
- 14 Oct 2008
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Project Ensuring Quality and Cooperation in the Chronic Obstructive Pulmonary Disease (COPD) Treatment
- ClinicalTrials.gov ID
- NCT00772733
- Acronym / sponsor ID
- KOSMOS / NIS-RDK-DUM-2007/1
- Conditions
- COPD, Chronic Diseases
- Keywords
- Quality assurance, rehabilitation, chronic care model, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 936 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Oct 2008 (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 ensure the quality of the COPD treatment in primary care by implementing planned follow-up visits, where the disease condition is evaluated and optimised in accordance with the national COPD recommendations. If relevant the general practitioner (GP) will refer patients to COPD rehabilitation conducted by relevant municipality rehabilitation teams. Secondarily the purpose is to improve collaboration and communication between the local hospital pulmonologist, GPs and the municipality rehabilitation team
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed patients with COPD, verified by spirometry in general practise and/or municipalities.
Key inclusion criteria (2 listed)
- COPD diagnose, verified by spirometry
- Having given informed consent
Key exclusion criteria (1 listed)
- -
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
Control visits at General practitioners
Time frame: 6-12 months
Lung function measured by spirometry
Time frame: 6-12 months
3 secondary outcomes
Dyspnoea on MRC scale
Time frame: 6-12 months
Smoking status
Time frame: 6-12 months
Rehabilitation completed in the municipality rehabilitation team
Time frame: 6-12 months
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 23 Feb 2011.
Related trials for COPD
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
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.
Michael Skov Jensen, MD study chair
Region Hospital Viborg, DK
Tina Brandt Sorensen, MD study chair
Region Hospital Horsens, DK
Ove Grann principal investigator
Aalborg
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Chronic Diseases, run by AstraZeneca at 11 sites in Denmark.
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 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Denmark. 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?
Control visits at General practitioners (time frame: 6-12 months). The study lists 2 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 23 Feb 2011.