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

November 14, 2016 updated by: Philipps University Marburg Medical Center

Molekularbiologische Eigenschaften Des Sputums während Einer Pulmonalen COPD Exacerbation

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Marburg, Germany, 35043
        • pulmonary department, University Marburg
      • Marburg, Germany
        • University Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

COPD patients Stadium 2-3 during pulmonary exacerbation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mucin concentration
Time Frame: 2 month
analyzing mucin concentration by western
2 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mucin stability
Time Frame: 2 month
analyzing mucin stability at 37C over 24 hours
2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Investigators

  • Principal Investigator: Markus Henke, MD, University Marburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 160/08

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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