Mucin Concentration in Sputum From COPD Patients During a Pulmonary Exacerbation

COPD Clinical Trial

— mucinCOPDex  

Official title:

Molekularbiologische Eigenschaften Des Sputums während Einer Pulmonalen COPD Exacerbation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01848093
• Other study ID #: 160/08
• Status: Withdrawn
• Phase: N/A
• First received: May 2, 2013
• Last updated: November 14, 2016
• Start date: December 2008
• Est. completion date: July 2013

Study information

• Verified date: May 2013
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• sputum collection
collecting of spontaneous sputum from the patient

Locations

Country	Name	City	State
Germany	pulmonary department, University Marburg	Marburg
Germany	University Marburg	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Henke MO, John G, Germann M, Lindemann H, Rubin BK. MUC5AC and MUC5B mucins increase in cystic fibrosis airway secretions during pulmonary exacerbation. Am J Respir Crit Care Med. 2007 Apr 15;175(8):816-21. — View Citation

Henke MO, John G, Rheineck C, Chillappagari S, Naehrlich L, Rubin BK. Serine proteases degrade airway mucins in cystic fibrosis. Infect Immun. 2011 Aug;79(8):3438-44. doi: 10.1128/IAI.01252-10. — View Citation

Henke MO, Renner A, Huber RM, Seeds MC, Rubin BK. MUC5AC and MUC5B Mucins Are Decreased in Cystic Fibrosis Airway Secretions. Am J Respir Cell Mol Biol. 2004 Jul;31(1):86-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mucin concentration	analyzing mucin concentration by western	2 month	No
Secondary	mucin stability	analyzing mucin stability at 37C over 24 hours	2 month	No