NCT01698151

Brief Summary

This is an observational study in primary care aiming to validate biomarkers for chronic obstructive pulmonary disease (COPD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

38 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

4.2 years

First QC Date

September 28, 2012

Last Update Submit

March 7, 2016

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive Pulmonary DiseaseCOPD

Outcome Measures

Primary Outcomes (1)

  • Hospitalization

    December 1, 2015

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in primary care on the Fyn island, Denmark

You may qualify if:

  • years old or more,
  • diagnosis of COPD in primary care

You may not qualify if:

  • Major psychiatric illness,
  • inability to visit primary care doctor,
  • inability to understand danish language,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Nyhegn, Søndergaard, Trabjerg og Vilhelmsen

Middelfart, Fyn, 5500, Denmark

RECRUITING

Lægerne J.B. Winsløws Vej

Odense, Fyn, 5000, Denmark

RECRUITING

Peter Larsen

Odense, Fyn, 5000, Denmark

TERMINATED

Peer Kirkebjerg

Odense C, Fyn, 5000, Denmark

RECRUITING

Lægerne Lærkevej

Otterup, Fyn, 5450, Denmark

WITHDRAWN

Søndersø Lægehus

Søndersø, Fyn, 5471, Denmark

WITHDRAWN

Lægerne i Bullerup

Agedrup, 5320, Denmark

TERMINATED

Lægehuset Skelvænget

Assens, 5610, Denmark

RECRUITING

Lægerne i Nr. Lyndelse

Årslev, 5792, Denmark

RECRUITING

Aaruplægerne

Årup, 5560, Denmark

RECRUITING

Lægerne Lægehuset

Faaborg, 5600, Denmark

RECRUITING

Per Andersen

Faaborg, 5600, Denmark

RECRUITING

Lægehuset i Gislev

Gislev, 5854, Denmark

WITHDRAWN

Haarbylægerne

Haarby, 5683, Denmark

RECRUITING

Jordløselægerne

Haarby, 5683, Denmark

RECRUITING

Lægerne i Hesselager

Hesselager, 5874, Denmark

COMPLETED

Lægerne i Hesselager

Hesselager, 5874, Denmark

RECRUITING

Lægerne Glenthøj & Nielsen

Kerteminde, 5300, Denmark

RECRUITING

Lægerne Tronegaard-Madsen og Schmidt

Kerteminde, 5300, Denmark

RECRUITING

Muusgaarden

Kerteminde, 5300, Denmark

RECRUITING

Lægerne i Kværndrup

Kværndrup, 5772, Denmark

RECRUITING

Lægerne i Havnegade

Middelfart, 5500, Denmark

RECRUITING

Lægehuset i Morud

Morud, 5462, Denmark

RECRUITING

Lægerne Nr. Voldgade

Nyborg, 5800, Denmark

RECRUITING

Lægerne Nyenstad

Nyborg, 5800, Denmark

TERMINATED

Bylægen Peer Kirkebjerg & Speciallæge Nanna Kirkebjerg

Odense, 5000, Denmark

RECRUITING

Læge Bo Gamborg Nielsen

Odense, 5000, Denmark

RECRUITING

Annette Tornøe

Odense C, 5000, Denmark

RECRUITING

Kirsten Wengler

Odense C, 5000, Denmark

RECRUITING

Læge Thore Eriksen

Odense C, 5000, Denmark

TERMINATED

Lægerne Agertoft og Petersen

Odense C, 5000, Denmark

RECRUITING

Almen Medicinsk Lægeklinik

Odense SØ, 5220, Denmark

RECRUITING

Lægerne Banepladsen

Otterup, 5450, Denmark

RECRUITING

Lægerne i Østergade

Ringe, 5750, Denmark

TERMINATED

Lægehuset Rudkøbing I/S

Rudkøbing, 5900, Denmark

RECRUITING

Lægerne Ørstedsgade

Rudkøbing, 5900, Denmark

RECRUITING

Lægerne Toldbodvej

Svendborg, 5700, Denmark

RECRUITING

Lægehuset i Vissenbjerg

Vissenbjerg, 5492, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24886233DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frans Boch Waldorff, MD, PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frans Boch Waldorff, MD, PhD

CONTACT

+45 6550 7643fwaldorff@health.sdu.dk

Helle Reintoft Andersen

CONTACT

+45 6550 3830hereandersen@health.sdu.dk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2012

First Posted

October 2, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

DK(38)