ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    Leuppi | Copd | Switzerland
Previous Study | Return to List | Next Study

Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02065921
Recruitment Status : Recruiting
First Posted : February 19, 2014
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland

Brief Summary:
  1. 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.

  2. 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.

  3. 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.

  4. Publication and authorship 4.1 Publication policy

Authorship credit is based on:

  1. Substantial contribution to conception and design, acquisition of data, or analysis and interpretation of data.
  2. Drafting the article or revising it critically for important intellectual content.
  3. 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.

Condition or disease
Chronic Obstructive Pulmonary Disease COPD Exacerbation

Study Type : Observational
Estimated Enrollment : 265 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort COPD-Management: Eine Klinisch-epidemiologische Verlaufsbeobachtung in Hausarztpraxen
Study Start Date : September 2006
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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



Primary Outcome Measures :
  1. Number of exacerbation [ Time Frame: 24 months ]
    no. of exacerbation and time to exacerbation over a time period of 2 years.


Secondary Outcome Measures :
  1. Disease progression [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed or existing COPD, who are managed in primary-care practices.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065921


Contacts
Contact: Jörg D Leuppi, MD, PhD,Prof. 061 925 2180 joerg.leuppi@ksbl.ch

Locations
Switzerland
Cantonal Hospital Baselland, Internal medicine University clinic Recruiting
Liestal, Baselland, Switzerland, 4410
Contact: Jörg D Leuppi, MD, PhD, Prof.    0041 61 925 21 80    joerg.leuppi@ksbl.ch   
Principal Investigator: Jörg D Leuppi, MD, PhD, Prof.         
Sponsors and Collaborators
Prof. Dr. Jörg Leuppi

Publications of Results:
Responsible Party: Prof. Dr. Jörg Leuppi, Chief of University medical Department Cantonal Hospital Baselland, Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier: NCT02065921     History of Changes
Other Study ID Numbers: EKBB170/06
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

Keywords provided by Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland:
COPD cohort
COPD management
exacerbation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases