Trial document




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  DRKS00015884

Trial Description

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Title

Impact of systemic manifestations/comorbidities on clinical state, prognosis and utilisation of health care resources in patients with COPD-COSYCONET2

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Trial Acronym

COSYCONET-Kohorte

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URL of the Trial

http://www.asconet.net

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Brief Summary in Lay Language

In this study we want to examine the correlation between the lung disease, comorbidities and systemic inflammation cross sectional and longitudinal. Thereby lays the focus on the course of the disease of patients with the COPD grades 0 - 2. The study is based on the methods and results of the COSYCONET study and use the findings of COSYCONET for the creation of a modified study protocol. Additionally the comparability of the two studies is ensured.

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Brief Summary in Scientific Language

The study "Impact of systemic manifestations/comorbidities on clinical state and prognosis of patients with chronic obstructive pneumonia disease" startet 2010 and is still running successfully. Up to now many valuable results for the role of comorbidities on the progression of the COPD and the utilization of health care could be publicise. A main aspect of the therapy of COPD is the early diagnosis. For this the research on early symptoms as well as changes in the functionality of the lung is very important. Therefore the focus of this study is the examination of patients of GOLD grades 0-2. Patients of GOLD grade 0 were even implemented in the COSYCONET study. This group turned out to be very heterogeneous but nevertheless clinical relevant because many of these patients had symptoms and took medication. The same was true for GOLD grade 1 patients. Because of this it is essential to characterize these patients in more detail. Additionally we want to include patients of GOLD grade 4 in the study. These patients are more heterogeneous than assumed and a more precise characterization of their functional limitations and symptoms is necessary for improving their survival.

The COSYCONET-2 study therefore represents more precise and extended questions compared to COSYCONET.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00015884
  •   2019/05/16
  •   [---]*
  •   yes
  •   Approved
  •   200/09, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

  •   U1111-1233-6076 
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Health Condition or Problem studied

  •   J44.8 -  Other specified chronic obstructive pulmonary disease
  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
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Interventions/Observational Groups

  •   The questions of the COSYCONET- 2 study represent a specification and extension of the COSYCONET study. It is planed to recruit 400 patients of GOLD grade 0-2 (mainly GOLD 0 and 1) and additionally 200 patients of grade 3 and 4 and examine the patients of grade 0-3 in the baseline and two follow up visits at 24 and 48 months after the baseline visit. Patients with severe COPD will be recruited from inpatients and a part of the data, mainly the functional data, will be extracted from the health records. Additionally to the visits telephone interviews every 6 months take place. In the interviews the patients answer questions to their medication intake, quality of life and number and severity of exacerbations. The interviews after one year additionally included the questions of the CAT questionnaire and the mMRC. Data of the severe patients were after the baseline visit only collected via telephone call. The study is non interventional.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
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Primary Outcome

Main outcome will be the multidimensional BODE-Score: however in COSYCONET-2 this score lays not in the focus of interest. Instead the aim is to answer many specific questions with specific disease entities and specific markers.

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Secondary Outcome

- to elaborate if the therapy of extrapulmonal disorders influence the progress of the COPD
- to elaborateif the therapy of the COPD influence the progress of extrapulmonal disorders
-to elaborate to what extend the comorbidity asthma through the analysis of sputume and exhaled nitirc oxide could be quatified
- to elaborate to what extend a new classification system could be developed for patients with light to moderate COPD
- to elaborate if patients with severe COPD could be differentiated in variable phenotypes and progression forms which are relvant for the therapy
-to describe the knowledge and self-management of COPD patients and to find out if knowledge and way of self-management correlate with the progression of the COPD
-to collect actual data of therapy of COPD patients and reasons why this therapy was chosen
-to identify markers in the blood with the aim to characterize the correlation between specific and unspecific markers and the COPD
- to analyse the utilization of the health care system and the associated costs

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/11/04
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   no maximum age
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Additional Inclusion Criteria

1. male or female, 2. 40 years old and older 3. Diagnosis COPD (GOLD 1 - 4) or 4. smoker or ex smoker with minimal 10 packyears and normal lungfunction (FEV1/FVC > =0.7 after bronchodilatation) and symptoms (>= 10 in CAT questionnaire or >= 2 in mMRC scale) or inhale minimal one bronchodilatator.
5. signed informed consent
6. cognitive and physical ability to meet the demands of the study protocol

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Exclusion Criteria

Having undergone lung surgery (e.g. lung volumen reduction, lung transplant)
Patients with lung cancer under treatment
Moderate or severe exacerbation within the last 4 weeks
Unable to understand the intention of the project,
former member of COSYCONET

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Philipps-Universität Marburg
    • Mr.  Prof. Dr. med.  Claus  Vogelmeier 
    • Baldinger Str.
    • 35043  Marburg
    • Germany
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    • Philipps-Universität Marburg Klinik für Innere Medizin mit SP Pneumologie Geschäftsstelle Kompetenznetz Asthma/COPD
    • Ms.  Dr.  Sandra  Söhler 
    • Baldinger Str.
    • 35043  Marburg
    • Germany
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    • Philipps-Universität Marburg Klinik für Innere Medizin mit Schwerpunkt Pneumologie Geschäftsstelle Kompetenznetz Asthma/COPD
    • Ms.  Dr.  Sandra   Söhler 
    • Baldinger Str.
    • 35043  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Lungenforschung e. V.
    • Mr.  Dr.  Christian  Kalberlah 
    • Aulweg 130
    • 35392  Gießen
    • Germany
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    • GlaxoSmithKline GmbH & Co. KG
    • 81675  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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