Cystic FibrosisNCT00266474
Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis
An observational study of Cystic Fibrosis 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 and the colonisation with Pseudomonas aerug. in the upper airways in patients with cystic fibrosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis, Sinusitis
- What is being tested?
- Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.
- How many people
- 187 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2005to Sep 2007
- 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
Who may be able to join
- Subject has a confirmed diagnosis of cystic fibrosis
Who cannot join
- current systemic therapy against Pseudomonas aeruginosa
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study is to detect the prevalence of chronic rhinosinusitis and the colonisation with Pseudomonas aerug. in the upper airways in patients with cystic fibrosis.
- Conditions
- Cystic Fibrosis, Sinusitis
- Being tested
- Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.
- Keywords
- Cystic Fibrosis with Chronic Rhinosinusitis
- Medical subject headings
- Cystic Fibrosis, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.Other
Also called nasal lavage and induced sputum
| Study group | Role | What they receive |
|---|---|---|
| Cross sectional CF study | Multicentric study, including 187 CF patients of all age groupr in 5 CF centres. Receives: Other: Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogen colonization in upper and lower airways
Measured: 3yrs
Sinonasal symptoms (SNOT-20)
Measured: 3 yrs
rhinomanometry and rhinoscopy
Measured: 3yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startDec 2005
- Study completionSep 2007
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 187 participants (actual)
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 G. Mainz, M.D., Study chair, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266474
- Sponsor's protocol ID
- CF_Sinusitis_QS
- Status last verified
- Dec 2014
- First submitted
- 15 Dec 2005
- Last updated
- 4 Dec 2014
- Results posted
- No
Publications
Mainz 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 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00266474
- Acronym / sponsor ID
- CF_Sinusitis_QS
- Conditions
- Cystic Fibrosis, Sinusitis
- Keywords
- Cystic Fibrosis with Chronic Rhinosinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Dec 2005
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Dec 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.
Aim of the study is to detect the prevalence of chronic rhinosinusitis and the colonisation with Pseudomonas aerug. in the upper airways in patients with cystic fibrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross sectional CF study | – | Other: Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.Multicentric study, including 187 CF patients of all age groupr in 5 CF centres. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has a confirmed diagnosis of cystic fibrosis
Key exclusion criteria (1 listed)
- current systemic therapy against Pseudomonas aeruginosa
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 |
|---|---|---|
| Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.Also: nasal lavage and induced sputum | Other | Cross sectional CF study |
Primary outcome
Pathogen colonization in upper and lower airways
Time frame: 3yrs
Sinonasal symptoms (SNOT-20)
Time frame: 3 yrs
rhinomanometry and rhinoscopy
Time frame: 3yrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- 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.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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 G. Mainz, M.D. study chair
University of Jena
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 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 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: finished, as of the sponsor's last update on 4 Dec 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pathogen colonization in upper and lower airways (time frame: 3yrs). The study lists 3 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 NCT00266474, 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 4 Dec 2014.