- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02065921
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort COPD-Management: Eine Klinisch-epidemiologische Verlaufsbeobachtung in Hausarztpraxen
Background Chronic Obstructive Pulmonary Disease (COPD) is an inflammatory disease of the lungs, which is most commonly caused by smoking. It is characterized as not fully reversible airflow limitation, chronic cough and dyspnoea. Being the fourth leading cause of death worldwide, COPD is an important public health challenge and can be prevented and treated. It is estimated that at least 400,000 individuals in Switzerland are affected by COPD. This number may increase in the coming years due to increasing nicotine consumption.
In response to the rising trend, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) has established new guidelines on the global strategy for diagnosis, management and prevention of COPD. Systematic diagnosis and stratification are crucial for effective treatment measures.
As COPD is an irreversible and progressive disease, its treatment aims an early detection and better management, which leads preventing progression. Disease management programs have shown that only patients who understand their exacerbation symptoms can benefit. Moreover, it is a major goal to improve health-related quality of life by reducing symptoms and decelerating disease progression.
Spirometry is the golden standard for the diagnosis of COPD, to assess the severity of the obstruction, and as a guide for optimal therapeutic measures.
Aim of the study The objective of this project is to establish a COPD cohort database to allow high quality research on diagnosis, treatment, complication and progression of COPD on long-term course.
Spirometry should be used consistently for the diagnosis and the monitoring of the development of the disease. Using collected information such as spirometric data, disease progression's data and therapeutic measures should help improve the management and self-management of the patients.
Methods 3.1 Study design We are conducting a prospective cohort study, based on COPD patients from northern and western Switzerland, who are managed under primary care setting. Patients with mild to very severe COPD (GLOD stages I-IV) are enrolled in the study.
Currently, 67 General practitioners (GPs) are participating in our Study. Each GP recruits 1-20 patients with presumed mild to very severe COPD according to criteria of the Global Initiative for Chronic Obstructive Lung disease [GOLD].
Patients' follow-up-visits occurs at 6-month intervals; their history, symptoms and examination status is recorded. Data is entered into an online database either by the physicians or by study team after receiving the collected data questionnaires by facsimile.
Data collection includes demographic data, physical examination, spirometric parameters, medical treatment and exacerbation history besides death.
A spirometer (EasyOne™, ndd Medizintechnik AG, Zürich, Switzerland) is used to assess lung function. All participating physicians were instructed on the usage of the spirometer and on how to complete spirometry according to the guidelines. For the assessment of the severity of COPD, we use the spirometric data provided by the GPs. The COPD severity is interpreted according to criteria of the GOLD committee.
3.2 Patient population Patients with newly diagnosed or existing COPD, who are managed in primary-care practices.
3.3 Inclusion criteria
- 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
Authorship credit is based on:
- 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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jörg D Leuppi, MD, PhD,Prof.
- Phone Number: 061 925 2180
- Email: joerg.leuppi@ksbl.ch
Study Locations
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Baselland
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Liestal, Baselland, Switzerland, 4410
- Recruiting
- Cantonal Hospital Baselland, Internal medicine University clinic
-
Contact:
- Jörg D Leuppi, MD, PhD, Prof.
- Phone Number: 0041 61 925 21 80
- Email: joerg.leuppi@ksbl.ch
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Principal Investigator:
- Jörg D Leuppi, MD, PhD, Prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- < 40 Years
- Tiffenau (FEV17FVC) > 70
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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COPD patients
establishing COPD cohort database to allow high quality research on diagnosis, treatment, complication and progression of COPD on long-term course.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of exacerbation
Time Frame: 24 months
|
no. of exacerbation and time to exacerbation over a time period of 2 years.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease progression
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKBB170/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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