Cystic Fibrosis With Other ManifestationsNCT00803881
Longitudinal Pathogen-colonization in Cystic Fibrosis Airways and Ability to Smell
An observational study of Cystic Fibrosis With Other Manifestations and Sinusitis, run by University of Jena at 1 site in Germany.
Trial summary
Aim of the study is to detect the prevalence of chronic rhinosinusitis, pathogen colonization of the lower and upper airways and, in a sub-cohort the sense of smelling in patients with cystic fibrosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis With Other Manifestations, Sinusitis
- What is being tested?
- nasal lavage and sputum collection
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2008to Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients of the CF outpatients clinic and hospitalized CF patients
Who may be able to join
- Subject has a confirmed diagnosis of cystic fibrosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Jena - CF-Center
Jena, 07740
Jochen Mainz, MD, +49 3641 938425, Jochen.Mainz@med.uni-jena.de
About this study
Official title: Prevalence of Chronic Rhinosinusitis, Pathogen-colonization in the Upper and Lower Airways and Ability to Smell in Cystic Fibrosis
Aim of the study is to detect the prevalence of chronic rhinosinusitis, pathogen colonization of the lower and upper airways and, in a sub-cohort the sense of smelling in patients with cystic fibrosis.
Read the detailed description
The sub-study on the sense of smelling in CF has been finalized in the meantime. Results were published in 2012:
Smell in cystic fibrosis. Lindig J, Steger C, Beiersdorf N, Michl R, Beck JF, Hummel T, Mainz JG. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):915-21. doi: 10.1007/s00405-012-2124-2. Epub 2012 Aug 14.
- Being tested
- nasal lavage and sputum collection
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal lavage and sputum collectionOther
Also called Pseudomonas aeruginosa antibodies in serum
non-invasive longitudinal assessment of pathogen colonization in both airway levels
| Study group | Role | What they receive |
|---|---|---|
| CF patients of all age groups | Longitudinal prospective assessment of upper and lower airway colonization in all patients attended in the Jena University CF centre Receives: Other: nasal lavage and sputum collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamics in CF upper and lower airway colonization with pathogens
longitudinal non-invasive sampling of upper and lower airways in CF
Measured: 10 years
Assessment of ability to smell in CF patients
Measured: 3 years
Secondary outcomes (1)
pulmonary function / BMI
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis With Other ManifestationsStudies 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
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Jochen G. Mainz, University of Jena
- Investigators
- Jochen Mainz, MD, Study chair, University of Jena - CF Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803881
- Sponsor's protocol ID
- CF_Sinusitis_LS
- Status last verified
- Oct 2016
- First submitted
- 5 Dec 2008
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindig J, Steger C, Beiersdorf N, Michl R, Beck JF, Hummel T, Mainz JG. Smell in cystic fibrosis. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):915-21. doi: 10.1007/s00405-012-2124-2. Epub 2012 Aug 14.
PubMed 22890694Mainz JG, Michl R, Pfister W, Beck JF. Cystic fibrosis upper airways primary colonization with Pseudomonas aeruginosa: eradicated by sinonasal antibiotic inhalation. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1089-90. doi: 10.1164/ajrccm.184.9.1089. No abstract available.
PubMed 22045752Mainz JG, Hentschel J, Schien C, Cramer N, Pfister W, Beck JF, Tummler B. Sinonasal persistence of Pseudomonas aeruginosa after lung transplantation. J Cyst Fibros. 2012 Mar;11(2):158-61. doi: 10.1016/j.jcf.2011.10.009. Epub 2011 Nov 30.
PubMed 22133899Mainz JG, Naehrlich L, Schien M, Kading M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tummler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.
PubMed 19282318
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chronic Rhinosinusitis, Pathogen-colonization in the Upper and Lower Airways and Ability to Smell in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00803881
- Acronym / sponsor ID
- CF_Sinusitis_LS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Dec 2008 (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.
Aim of the study is to detect the prevalence of chronic rhinosinusitis, pathogen colonization of the lower and upper airways and, in a sub-cohort the sense of smelling in patients with cystic fibrosis.
Detailed description
The sub-study on the sense of smelling in CF has been finalized in the meantime. Results were published in 2012:
Smell in cystic fibrosis. Lindig J, Steger C, Beiersdorf N, Michl R, Beck JF, Hummel T, Mainz JG. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):915-21. doi: 10.1007/s00405-012-2124-2. Epub 2012 Aug 14.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF patients of all age groups | – | Other: nasal lavage and sputum collectionLongitudinal prospective assessment of upper and lower airway colonization in all patients attended in the Jena University CF centre |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients of the CF outpatients clinic and hospitalized CF patients
Key inclusion criteria (1 listed)
- Subject has a confirmed diagnosis of cystic fibrosis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| nasal lavage and sputum collectionAlso: Pseudomonas aeruginosa antibodies in serumnon-invasive longitudinal assessment of pathogen colonization in both airway levels | Other | CF patients of all age groups |
Primary outcome
Dynamics in CF upper and lower airway colonization with pathogens
Time frame: 10 years
longitudinal non-invasive sampling of upper and lower airways in CF
Assessment of ability to smell in CF patients
Time frame: 3 years
1 secondary outcome
pulmonary function / BMI
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Background: PubMed 22890694Lindig J, Steger C, Beiersdorf N, Michl R, Beck JF, Hummel T, Mainz JG. Smell in cystic fibrosis. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):915-21. doi: 10.1007/s00405-012-2124-2. Epub 2012 Aug 14.
- Background: PubMed 22045752Mainz JG, Michl R, Pfister W, Beck JF. Cystic fibrosis upper airways primary colonization with Pseudomonas aeruginosa: eradicated by sinonasal antibiotic inhalation. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1089-90. doi: 10.1164/ajrccm.184.9.1089. No abstract available.
- Background: PubMed 22133899Mainz JG, Hentschel J, Schien C, Cramer N, Pfister W, Beck JF, Tummler B. Sinonasal persistence of Pseudomonas aeruginosa after lung transplantation. J Cyst Fibros. 2012 Mar;11(2):158-61. doi: 10.1016/j.jcf.2011.10.009. Epub 2011 Nov 30.
- Background: PubMed 19282318Mainz JG, Naehrlich L, Schien M, Kading M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tummler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.
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.
Jochen Mainz, MD study chair
University of Jena - CF Center
1 site 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 With Other Manifestations and Sinusitis, run by University of Jena at 1 site 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 1 inclusion and 0 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 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jochen Mainz, MD (+49 3641 938425, Jochen.Mainz@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamics in CF upper and lower airway colonization with pathogens (time frame: 10 years). The study lists 2 primary outcomes in all. 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 NCT00803881, which also lists 4 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 25 Oct 2016.