NCT00266474

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

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, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

First QC Date

December 15, 2005

Last Update Submit

December 3, 2014

Conditions

Cystic FibrosisSinusitis

Keywords

Cystic Fibrosis with Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (3)

  • Pathogen colonization in upper and lower airways

    3yrs

  • Sinonasal symptoms (SNOT-20)

    3 yrs

  • rhinomanometry and rhinoscopy

    3yrs

Study Arms (1)

Cross sectional CF study

Multicentric study, including 187 CF patients of all age groupr in 5 CF centres.

Other: Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.

Interventions

Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.OTHER
Also known as: nasal lavage and induced sputum
Cross sectional CF study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has a confirmed diagnosis of cystic fibrosis

You may not qualify if:

  • current systemic therapy against Pseudomonas aeruginosa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich-Schiller-Universität

Jena, Thuringia, 07740, Germany

Location

Related Publications (1)

  • 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.

    PMID: 19282318BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Pseudomonas aeruginosa and Staphylococcus aureus cultures (SNPS)

MeSH Terms

Conditions

Cystic FibrosisSinusitis

Interventions

Health Records, PersonalRhinomanometryNasal Lavage

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesRespiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Medical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisManometryTherapeutic Irrigation

Study Officials

  • Jochen G. Mainz, M.D.

    University of Jena

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of CF Center, Pediatric Pulmonology

Study Record Dates

First Submitted

December 15, 2005

First Posted

December 16, 2005

Study Start

December 1, 2005

Study Completion

September 1, 2007

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

DE(1)