Mucin Concentration in Sputum From COPD Patients During a Pulmonary Exacerbation

NCT ID: NCT01848093

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

lung airway pulmonary exacerbation mucus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COPD exacerbation

COPD Stadium 2 and 3 during pulmonary exacerbation

sputum collection

sputum collection

Intervention Type OTHER

collecting of spontaneous sputum from the patient

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sputum collection

collecting of spontaneous sputum from the patient

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Markus Henke, MD

Role: PRINCIPAL_INVESTIGATOR

University Marburg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

pulmonary department, University Marburg

Marburg, , Germany

Site Status

University Marburg

Marburg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 14988081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21646446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17255563 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

160/08

Identifier Type: -

Identifier Source: org_study_id