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Mucin Concentration in Sputum From COPD Patients During a Pulmonary Exacerbation (mucinCOPDex)

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ClinicalTrials.gov Identifier: NCT01848093
Recruitment Status : Withdrawn
First Posted : May 7, 2013
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

Brief Summary:

chronic obstructive pulmonary disease (COPD) is typically associated with mucus hypersecretion in the airways. In health, mucin is the major macromolecular component and is responsible for the protective and clearance properties of the mucus gel. In a recent study the investigators found that mucins are decreased and unstable in the sputum of adult cystic fibrosis (CF) patients.

In this study the investigators want to investigate the differences on the mucin quantity and quality of airway secretions during pulmonary exacerbation of patients with COPD.


Condition or disease Intervention/treatment
COPD Other: sputum collection

Detailed Description:

We hypothesize that during an exacerbation the mucin amount is increasing.

The aim of this study is to evaluate the molecular (mucins) and structure properties (mucin-stability) of the airway secretions in COPD related to the severity of the disease.

We characterize sputum composition of patients with pulmonary exacerbations. Using gel electrophoresis, with specific antibodies we will analyze MUC5AC and MUC5B mucins.

The significance of these studies is that they will give us novel information about the pathogenesis of chronic inflammatory airway diseases, provide tools for assessing the progression of lung disease, and most critically, will identify novel opportunities and targets for therapeutic intervention.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Molekularbiologische Eigenschaften Des Sputums während Einer Pulmonalen COPD Exacerbation
Study Start Date : December 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Group/Cohort Intervention/treatment
COPD exacerbation

COPD Stadium 2 and 3 during pulmonary exacerbation

sputum collection

Other: sputum collection
collecting of spontaneous sputum from the patient




Primary Outcome Measures :
  1. mucin concentration [ Time Frame: 2 month ]
    analyzing mucin concentration by western


Secondary Outcome Measures :
  1. mucin stability [ Time Frame: 2 month ]
    analyzing mucin stability at 37C over 24 hours


Biospecimen Retention:   Samples Without DNA
sputum


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
COPD patients Stadium 2-3 during pulmonary exacerbation
Criteria

Inclusion Criteria:

  • forced expiratory volume at one second (FEV1) < 80%
  • sputum production
  • clinical likely hood of exacerbation

Exclusion Criteria:

  • FEV1 > 80% or < 30%
  • increased systemic inflammation
  • susceptibility of pneumonia
  • need for antibiotic treatment

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): NCT01848093


Locations
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Germany
pulmonary department, University Marburg
Marburg, Germany, 35043
University Marburg
Marburg, Germany
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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Principal Investigator: Markus Henke, MD University Marburg