NCT01848093

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 15, 2016

Status Verified

May 1, 2013

Enrollment Period

4.5 years

First QC Date

May 2, 2013

Last Update Submit

November 14, 2016

Conditions

Keywords

lungairwaypulmonary exacerbationmucus

Outcome Measures

Primary Outcomes (1)

  • mucin concentration

    analyzing mucin concentration by western

    2 month

Secondary Outcomes (1)

  • mucin stability

    2 month

Study Arms (1)

COPD exacerbation

COPD Stadium 2 and 3 during pulmonary exacerbation sputum collection

Other: sputum collection

Interventions

collecting of spontaneous sputum from the patient

COPD exacerbation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COPD patients Stadium 2-3 during pulmonary exacerbation

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

pulmonary department, University Marburg

Marburg, 35043, Germany

Location

University Marburg

Marburg, Germany

Location

Related Publications (3)

  • 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.

    PMID: 14988081BACKGROUND
  • 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.

    PMID: 21646446BACKGROUND
  • 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.

    PMID: 17255563BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Markus Henke, MD

    University Marburg

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 7, 2013

Study Start

December 1, 2008

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

November 15, 2016

Record last verified: 2013-05

Locations