Chronic Obstructive Pulmonary Disease (COPD)PROTECCT-MNCT01698151
Prognosis and Treatment of COPD in Primary Care-use of Biomarkers
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by University of Southern Denmark at 38 sites in Denmark.
Trial summary
This is an observational study in primary care aiming to validate biomarkers for chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 2,000 participants
- Where
- 38 sitesDenmark
- Study dates
- Oct 2012to Dec 2018
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in primary care on the Fyn island, Denmark
Who may be able to join
- 40 years old or more,
- diagnosis of COPD in primary care
Who cannot join
- Major psychiatric illness,
- inability to visit primary care doctor,
- inability to understand danish language,
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Denmark38 sites, 29 recruiting
- Terminated
Lægerne i Bullerup
Agedrup, 5320
- Recruiting
Lægerne i Nr. Lyndelse
Årslev, 5792
Lisbeth Muncke Møller, Cand.med., +45 65901019, nrlyn.lc@gmail.com
- Recruiting
Aaruplægerne
Årup, 5560
Klaus Roslind, MD, +45 6443 1024, k.roslind@dadlnet.dk
- Recruiting
Lægehuset Skelvænget
Assens, 5610
Ester Vad, MD, +45 64711065, vadiversen@hotmail.com
- Recruiting
Lægerne Lægehuset
Faaborg, 5600
Per Andersen, MD, +45 62610108
- Recruiting
Per Andersen
Faaborg, 5600
Per Andersen, MD, per.andersen@dadlnet.dk
- Withdrawn
Lægehuset i Gislev
Gislev, 5854
- Recruiting
Haarbylægerne
Haarby, 5683
Lisbeth Johansen, MD, +45 64731616, haarbylaegerne@post1.tele.dk
- Recruiting
Jordløselægerne
Haarby, 5683
Mia Skytte Petersen, MD, +45 64732312, mia@halldorgg.com
- Completed
Lægerne i Hesselager
Hesselager, 5874
- Recruiting
Lægerne i Hesselager
Hesselager, 5874
Tina Riis Jørgensen, Cand.med., +45 62271089, tinariis@hotmail.com
- Recruiting
Lægerne Glenthøj & Nielsen
Kerteminde, 5300
Hanne Nielsen, +45 65321743, birkevej.kerteminde@mail.dk
- Recruiting
Lægerne Tronegaard-Madsen og Schmidt
Kerteminde, 5300
Tronegaard-Madsen, MD, +45 65321048, surlemont@hotmail.com
- Recruiting
Muusgaarden
Kerteminde, 5300
Dorte Ejg Jarbøl, MD, +45 22486886, djarbol@health.sdu.dk
- Recruiting
Lægerne i Kværndrup
Kværndrup, 5772
Tina Riis, MD, +45 62271089, tinariis@hotmail.com
- Recruiting
Nyhegn, Søndergaard, Trabjerg og Vilhelmsen
Middelfart, Fyn, 5500
Lene Søndergaard, MD, +45 23675570, lene-soendergaard@dadlnet.dk
- Recruiting
Lægerne i Havnegade
Middelfart, 5500
Jeff Sørensen, MD, +45 64410942, laegerneihavnegade@live.dk
- Recruiting
Lægehuset i Morud
Morud, 5462
Elsebeth Lindegaard, MD, +45 65964125
- Recruiting
Lægerne Nr. Voldgade
Nyborg, 5800
Alice Vesterbjerg, MD, +45 65310143, alis@huslaegerne.dk
- Terminated
Lægerne Nyenstad
Nyborg, 5800
- Recruiting
Lægerne J.B. Winsløws Vej
Odense, Fyn, 5000
Henrik K. Laustrup, MD, +45 65504001, hl@winsloewsvej.dk
- Terminated
Peter Larsen
Odense, Fyn, 5000
- Recruiting
Bylægen Peer Kirkebjerg & Speciallæge Nanna Kirkebjerg
Odense, 5000
Nanna Kirkebjeg, MD, +45 66 12 51 30
- Recruiting
Læge Bo Gamborg Nielsen
Odense, 5000
Bo Gamborg Nielsen, MD, +4566176600
- Recruiting
Peer Kirkebjerg
Odense C, Fyn, 5000
Peter Larsen, MD, +45 66125130
- Recruiting
Annette Tornøe
Odense C, 5000
Annette Tornøe, MD, +4565919146, a.tornoe@dadlnet.dk
- Recruiting
Kirsten Wengler
Odense C, 5000
Kirsten Wengler, MD, +4565919146, kwengler@dadlnet.dk
- Terminated
Læge Thore Eriksen
Odense C, 5000
- Recruiting
Lægerne Agertoft og Petersen
Odense C, 5000
Agertoft, MD, +66112101
- Recruiting
Almen Medicinsk Lægeklinik
Odense SØ, 5220
Rasmus Dahl Larsen, MD, +45 66179017
- Withdrawn
Lægerne Lærkevej
Otterup, Fyn, 5450
- Recruiting
Lægerne Banepladsen
Otterup, 5450
Martin Munk, MD, +45 64821027, martinmunk@dadlnet.dk
- Terminated
Lægerne i Østergade
Ringe, 5750
- Recruiting
Lægehuset Rudkøbing I/S
Rudkøbing, 5900
Sanne Uhrenholt Andersen, +45 63511700, jv@ruddoc.dk
- Recruiting
Lægerne Ørstedsgade
Rudkøbing, 5900
Jens Stærk Jensen, MD, +45 62515141, laegerne@oerstedsgade.dk
- Withdrawn
Søndersø Lægehus
Søndersø, Fyn, 5471
- Recruiting
Lægerne Toldbodvej
Svendborg, 5700
Henrik Lund, MD, +45 62214518, henrik.lund@dadlnet.dk
- Recruiting
Lægehuset i Vissenbjerg
Vissenbjerg, 5492
Thomas Kanstrup, MD, +45 64471077, 5492vissenbjerg@gmail.com
About this study
This is an observational study in primary care aiming to validate biomarkers for chronic obstructive pulmonary disease (COPD).
- Keywords
- Chronic obstructive Pulmonary Disease, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization
Measured: December 1, 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2018 (estimated)
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 Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Region of Southern Denmark
- Responsible party
- Principal investigator, Frans Boch Waldorff, University of Southern Denmark
- Investigators
- Frans Boch Waldorff, MD, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698151
- Sponsor's protocol ID
- S-20110163
- Acronym
- PROTECCT-M
- Status last verified
- Mar 2016
- First submitted
- 28 Sep 2012
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sondergaard J, Halling A. The PROTECCT-M study: a cohort study investigating associations between novel specific biomarkers, patient-related, healthcare system markers and the trajectory of COPD patients treated in primary care. BMC Pulm Med. 2014 May 20;14:88. doi: 10.1186/1471-2466-14-88.
PubMed 24886233
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis and Treatment of COPD in Primary Care-use of Biomarkers
- ClinicalTrials.gov ID
- NCT01698151
- Acronym / sponsor ID
- PROTECCT-M / S-20110163
- Keywords
- Chronic obstructive Pulmonary Disease, COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Region of Southern Denmark
- Study start
- Oct 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 Oct 2012 (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.
This is an observational study in primary care aiming to validate biomarkers for chronic obstructive pulmonary disease (COPD).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in primary care on the Fyn island, Denmark
Key inclusion criteria (2 listed)
- 40 years old or more,
- diagnosis of COPD in primary care
Key exclusion criteria (3 listed)
- Major psychiatric illness,
- inability to visit primary care doctor,
- inability to understand danish language,
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
Hospitalization
Time frame: December 1, 2015
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Derived from this study: PubMed 24886233Sondergaard J, Halling A. The PROTECCT-M study: a cohort study investigating associations between novel specific biomarkers, patient-related, healthcare system markers and the trajectory of COPD patients treated in primary care. BMC Pulm Med. 2014 May 20;14:88. doi: 10.1186/1471-2466-14-88.
- Homepage for studyLink provided by the sponsor.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Frans Boch Waldorff, MD, PhD principal investigator
University of Southern Denmark
38 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 (COPD), run by University of Southern Denmark at 38 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 3 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: status not confirmed, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frans Boch Waldorff, MD, PhD (+45 6550 7643, fwaldorff@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization (time frame: December 1, 2015). 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 NCT01698151, 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 8 Mar 2016.