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Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health Care Resources in Patients With COPD (COSYCONET)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01245933
Recruitment Status : Active, not recruiting
First Posted : November 23, 2010
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
Hannover Medical School
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Claus Vogelmeier, Philipps University Marburg Medical Center

Brief Summary:

The purpose of this study is to determine the prevalence and severity of extrapulmonary disorders and to quantify the impact of extrapulmonary organ manifestations on morbidity and mortality of COPD patients.

Furthermore the investigators evaluate the relationship between systemic inflammation and organ involvement.


Condition or disease
Chronic Obstructive Pulmonary Disease (COPD)

Detailed Description:
Chronic diseases and comorbidities have an increasing impact on individual life and health care use, as exemplified in chronic obstructive pulmonary disease (COPD). Currently, independent, comprehensive databases allowing for an integrated view are lacking. The study will for the first time establish a large, comprehensive longitudinal database covering a broad panel of comorbidities an markers of systemic alterations. These data will be of unique value in revealing specific phenotypes of COPD via patterns and risk profiles of comorbidities, enabling a more precise diagnosis and targeting of therapy, and an efficient allocation of resources.

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Study Type : Observational
Actual Enrollment : 2741 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis and Utilisation of Health Care Resources in Patients With COPD
Study Start Date : November 2010
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : July 2021



Primary Outcome Measures :
  1. Change from baseline in BODE-Score at 18 months [ Time Frame: at initial visite, after 18 month ]
    The BODE-Score comprises BMI, airway obstruction, dyspnea and exercise capacity and is a good predictor for death in COPD patients. Progression is defined as a change in BODE-score by >=1 point over the observation period.


Secondary Outcome Measures :
  1. COPD related mortality [ Time Frame: after 18 months ]
    The rate of mortality was elevated after 6, 18, 36 and 54 months

  2. COPD related hospitalization [ Time Frame: after 18 months ]
    The rate of hospitalizations was elevated in every visit.


Biospecimen Retention:   Samples With DNA
blood urine sputum


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.


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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
Since the original recruitment strategy was not as successful as expected,the mode of recruitment was extended to other physicians, patients' groups and organisations and advertising to local media. The recruitment is supported by professional measures of communication organized by the coordinating centre Marburg.
Criteria

Inclusion Criteria:

  • aged 40 years and older
  • diagnosis of COPD (GOLD-Criteria) or chronic bronchitis
  • informed consent
  • available for repeated study visits pver 18 months

Exclusion Criteria:

  • having undergone big lung surgery (e.g. lung reduction, lung transplant)
  • Moderate or severe exacerbation within the last 4 weeks
  • having a lung tumor
  • Unable to walk or to understand the intention of the project

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): NCT01245933


Locations
Show Show 22 study locations
Sponsors and Collaborators
Philipps University Marburg Medical Center
Hannover Medical School
Ludwig-Maximilians - University of Munich
Investigators
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Study Chair: Claus Vogelmeier, Prof. Philipps University Marburg Medical Center
Additional Information:
Study Data/Documents: general information  This link exits the ClinicalTrials.gov site

Publications of Results:
Smid DE, Franssen FME, Gonik M, Miravitlles M, Casanova C, Cosio BG, de Lucas-Ramos P, Marin JM, Martinez C, Mir I, Soriano JB, de Torres JP, Agusti A, Atalay NB, Billington J, Boutou AK, Brighenti-Zogg S, Chaplin E, Coster S, Dodd JW, Dürr S, Fernandez-Villar A, Groenen MTJ, Guimarães M, Hejduk K, Higgins V, Hopkinson NS, Horita N, Houben-Wilke S, Janssen DJA, Jehn M, Joerres R, Karch A, Kelly JL, Kim YI, Kimura H, Koblizek V, Kocks JH, Kon SSC, Kwon N, Ladeira I, Lee SD, Leuppi JD, Locantore N, Lopez-Campos JL, D-C Man W, Maricic L, Mendoza L, Miedinger D, Mihaltan F, Minami S, van der Molen T, Murrells TJ, Nakken N, Nishijima Y, Norman IJ, Novotna B, O'Donnell DE, Ogata Y, Pereira ED, Piercy J, Price D, Pothirat C, Raghavan N, Ringbaek T, Sajkov D, Sigari N, Singh S, Small M, da Silva GF, Tanner RJ, Tsiligianni IG, Tulek B, Tzanakis N, Vanfleteren LEGW, Watz H, Webb KA, Wouters EFM, Xie GG, Yoshikawa M, Spruit MA. Redefining Cut-Points for High Symptom Burden of the Global Initiative for Chronic Obstructive Lung Disease Classification in 18,577 Patients With Chronic Obstructive Pulmonary Disease. J Am Med Dir Assoc. 2017 Dec 1;18(12):1097.e11-1097.e24. doi: 10.1016/j.jamda.2017.09.003. Review.

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Claus Vogelmeier, Prof. Dr., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01245933    
Other Study ID Numbers: 01GI0881
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Keywords provided by Claus Vogelmeier, Philipps University Marburg Medical Center:
COPD
register
comorbidities
systemic inflammation
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases