Clinical trial NCT01848093: Mucin Concentration in Sputum From COPD Patients During a Pulmonary Exacerbation
Official title: Molekularbiologische Eigenschaften Des Sputums während Einer Pulmonalen COPD Exacerbation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COPD
Keywords: lung
airway
pulmonary exacerbation
mucus
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients Stadium 2-3 during pulmonary exacerbation

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.

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.

Eligibility 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

Primary outcomes:
measure: mucin concentration
timeFrame: 2 month
Secondary outcomes:
measure: mucin stability
timeFrame: 2 month
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: pulmonary department, University Marburg
city: Marburg
country: Germany
facility: University Marburg
Study officials:
affiliation: University Marburg
name: Markus Henke, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1165/rcmb.2003-0345OC. Epub 2004 Feb 26.
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. Epub 2011 Jun 6.
citation: 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. doi: 10.1164/rccm.200607-1011OC. Epub 2007 Jan 25.