NCT02065921

Brief Summary

  • Tiffenau (FEV17FVC) \< 70 without reversibility (Increase in FEV1 after inhalation of a bronchodilator \<200 ml and \<12%).
  • Age: \> 40 years
  • Both genders
  • Smokers or ex-smokers of at least 20 pack years.
  • Informed consent. 3.4 Archiving and Data Retention All study-related records such as medical records, informed consent documents, information regarding participants who discontinued, and other pertinent data will be maintained and therefore retained as long as required by the applicable Swiss regulatory requirements (10 Years). 3.5 Data security The complete data of the study will be entered anonymously into a database. The data is password-protected and can only be accessed by investigators and study members.
  • Publication and authorship 4.1 Publication policy
  • Substantial contribution to conception and design, acquisition of data, or analysis and interpretation of data.
  • Drafting the article or revising it critically for important intellectual content.
  • Final approval of the version to be published. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.

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
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2006

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

19 years

First QC Date

February 14, 2014

Last Update Submit

September 5, 2023

Conditions

Keywords

COPD cohortCOPD managementexacerbation

Outcome Measures

Primary Outcomes (1)

  • Number of exacerbation

    no. of exacerbation and time to exacerbation over a time period of 2 years.

    24 months

Secondary Outcomes (1)

  • Disease progression

    2 years

Study Arms (1)

COPD patients

establishing COPD cohort database to allow high quality research on diagnosis, treatment, complication and progression of COPD on long-term course.

Eligibility Criteria

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

Patients with newly diagnosed or existing COPD, who are managed in primary-care practices.

You may qualify if:

  • Tiffenau (FEV17FVC) \< 70 without reversibility (Increase in FEV1 after inhalation of a bronchodilator \<200 ml and \<12%).
  • Age: \> 40 years
  • Both genders
  • Smokers or ex-smokers of at least 20 pack years.
  • Informed consent.

You may not qualify if:

  • \< 40 Years
  • Tiffenau (FEV17FVC) \> 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cantonal Hospital Baselland, Internal medicine University clinic

Liestal, Basel-Landschaft, 4410, Switzerland

RECRUITING

Related Publications (3)

  • Jochmann A, Scherr A, Jochmann DC, Miedinger D, Torok SS, Chhajed PN, Tamm M, Leuppi JD. Impact of adherence to the GOLD guidelines on symptom prevalence, lung function decline and exacerbation rate in the Swiss COPD cohort. Swiss Med Wkly. 2012 Apr 5;142:w13567. doi: 10.4414/smw.2012.13567. eCollection 2012.

  • Jochmann A, Neubauer F, Miedinger D, Schafroth S, Tamm M, Leuppi JD. General practitioner's adherence to the COPD GOLD guidelines: baseline data of the Swiss COPD Cohort Study. Swiss Med Wkly. 2010 Aug 9;140:10.4414/smw.2010.13053. doi: 10.4414/smw.2010.13053. eCollection 2010.

  • Urwyler P, Abu Hussein N, Bridevaux PO, Chhajed PN, Geiser T, Grendelmeier P, Joos Zellweger L, Kohler M, Maier S, Miedinger D, Tamm M, Thurnheer R, Dieterle T, Leuppi JD. Predictive factors for exacerbation and re-exacerbation in chronic obstructive pulmonary disease: an extension of the Cox model to analyze data from the Swiss COPD cohort. Multidiscip Respir Med. 2019 Feb 5;14:7. doi: 10.1186/s40248-019-0168-5. eCollection 2019.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jörg D Leuppi, MD, PhD,Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of University medical Department Cantonal Hospital Baselland

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 19, 2014

Study Start

September 1, 2006

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations