Cystic FibrosisNCT00202072
Mucin in Sputum of CF During Pulmonary Exacerbation
An observational study of Cystic Fibrosis, run by Philipps University Marburg at 2 sites in Germany.
Trial summary
The purpose of this study is to determine whether mucin is increased during pulmonay exacerbations in adult patients with cystic fibrosis (CF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 25 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2004to Sep 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cystic fibrosis
- chronic pseudomonas aeruginosa inflammation
- pulmonary exacerbation
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Pediatric department, CF center, University Giessen
Giessen
Hermann Lindemann, MD, 0641/99 ext. 43430, Hermann.Lindemann@paediat.med.uni-giessen.de
- Recruiting
Pediatric department, CF center, University Marburg
Marburg
Markus O Henke, MD, 06421 ext. 2866041, markus.henke@staff.uni-marburg.de
About this study
The purpose of this study is to determine whether mucin is increased during pulmonay exacerbations in adult patients with cystic fibrosis (CF).
Read the detailed description
CF 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 we found that mucins are decreased in the sputum of adult CF patients.
In this study we want to investigate the differences on the mucin and DNA quantity and quality of airway secretions in during pulmoanry exacerbation.We hypothesize that during an exacerbation the mucin and DNA amount is increasing.
The aim of this study is to evaluate the molecular (mucins) and structure properties (mucin-DNA-network) of the airway secretions in CF related to the severity of the disease.
We characterize sputum composition of patients with pulmonary exacerbations. Using gel electrophoresis and dot-blot with specific antibodies we will analyze MUC5AC and MUC5B mucins. DNA amount will be measured by microfluorimetry. With the laser scanning confocal microscopy the mucin-DNA-network will be evaluated.
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
- Cystic Fibrosis
- Keywords
- lung, airway, pulmonary exacerbation, mucus
- Medical subject headings
- Cystic Fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies 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
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Investigators
- Markus O Henke, MD, Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202072
- Sponsor's protocol ID
- 208/03
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- 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 14988081
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucin in Sputum of CF During Pulmonary Exacerbation
- ClinicalTrials.gov ID
- NCT00202072
- Acronym / sponsor ID
- 208/03
- Conditions
- Cystic Fibrosis
- Keywords
- lung, airway, pulmonary exacerbation, mucus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Sep 2005
- First posted
- 20 Sep 2005 (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.
The purpose of this study is to determine whether mucin is increased during pulmonay exacerbations in adult patients with cystic fibrosis (CF).
Detailed description
CF 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 we found that mucins are decreased in the sputum of adult CF patients.
In this study we want to investigate the differences on the mucin and DNA quantity and quality of airway secretions in during pulmoanry exacerbation.We hypothesize that during an exacerbation the mucin and DNA amount is increasing.
The aim of this study is to evaluate the molecular (mucins) and structure properties (mucin-DNA-network) of the airway secretions in CF related to the severity of the disease.
We characterize sputum composition of patients with pulmonary exacerbations. Using gel electrophoresis and dot-blot with specific antibodies we will analyze MUC5AC and MUC5B mucins. DNA amount will be measured by microfluorimetry. With the laser scanning confocal microscopy the mucin-DNA-network will be evaluated.
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
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cystic fibrosis
- chronic pseudomonas aeruginosa inflammation
- pulmonary exacerbation
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
- 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.
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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 O Henke, MD principal investigator
Philipps 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 Cystic Fibrosis, 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 1 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: status not confirmed, as of the sponsor's last update on 20 Sep 2005. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus O Henke, MD (06421 ext. 2866041, markus.henke@staff.uni-marburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00202072, which also lists 1 linked publication.
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 20 Sep 2005.