COPDmucinCOPDexNCT01848093
Mucin Concentration in Sputum From COPD Patients During a Pulmonary Exacerbation
An observational study of COPD, run by Philipps University Marburg at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- sputum collection
- How many people
- 0 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2008to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients Stadium 2-3 during pulmonary exacerbation
Who may be able to join
- forced expiratory volume at one second (FEV1) < 80%
- sputum production
- clinical likely hood of exacerbation
Who cannot join
- FEV1 > 80% or < 30%
- increased systemic inflammation
- susceptibility of pneumonia
- need for antibiotic treatment
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
pulmonary department, University Marburg
Marburg, 35043
University Marburg
Marburg
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD
- Being tested
- sputum collection
- Keywords
- lung, airway, pulmonary exacerbation, mucus
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sputum collectionOther
collecting of spontaneous sputum from the patient
| Study group | Role | What they receive |
|---|---|---|
| COPD exacerbation | COPD Stadium 2 and 3 during pulmonary exacerbation
sputum collection Receives: Other: sputum collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
mucin concentration
analyzing mucin concentration by western
Measured: 2 month
Secondary outcomes (1)
mucin stability
analyzing mucin stability at 37C over 24 hours
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startDec 2008
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Henke, MD, Principal investigator, University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848093
- Sponsor's protocol ID
- 160/08
- Acronym
- mucinCOPDex
- Status last verified
- May 2013
- First submitted
- 2 May 2013
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14988081Henke 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.
PubMed 21646446Henke 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.
PubMed 17255563
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molekularbiologische Eigenschaften Des Sputums während Einer Pulmonalen COPD Exacerbation
- ClinicalTrials.gov ID
- NCT01848093
- Acronym / sponsor ID
- mucinCOPDex / 160/08
- Conditions
- COPD
- Keywords
- lung, airway, pulmonary exacerbation, mucus
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD exacerbation | – | Other: sputum collectionCOPD Stadium 2 and 3 during pulmonary exacerbation sputum collection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients Stadium 2-3 during pulmonary exacerbation
Key inclusion criteria (3 listed)
- forced expiratory volume at one second (FEV1) < 80%
- sputum production
- clinical likely hood of exacerbation
Key exclusion criteria (4 listed)
- FEV1 > 80% or < 30%
- increased systemic inflammation
- susceptibility of pneumonia
- need for antibiotic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sputum collectioncollecting of spontaneous sputum from the patient | Other | COPD exacerbation |
Primary outcome
mucin concentration
Time frame: 2 month
analyzing mucin concentration by western
1 secondary outcome
mucin stability
Time frame: 2 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Background: PubMed 14988081Henke 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.
- Background: PubMed 21646446Henke 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.
- Background: PubMed 17255563Henke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Henke, MD principal investigator
University Marburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Philipps University Marburg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mucin concentration (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01848093, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.