Longitudinal Pathogen-colonization in Cystic Fibrosis Airways and Ability to Smell

NCT ID: NCT00803881

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis With Other Manifestations Sinusitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

nasal lavage and sputum collection

Intervention Type OTHER

non-invasive longitudinal assessment of pathogen colonization in both airway levels

Interventions

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nasal lavage and sputum collection

non-invasive longitudinal assessment of pathogen colonization in both airway levels

Intervention Type OTHER

Other Intervention Names

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Pseudomonas aeruginosa antibodies in serum

Eligibility Criteria

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Inclusion Criteria

* Subject has a confirmed diagnosis of cystic fibrosis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jena

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Jochen G. Mainz

Head of CF Center, Pediatric Pulmonology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jochen Mainz, MD

Role: STUDY_CHAIR

University of Jena - CF Center

Locations

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University of Jena - CF-Center

Jena, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jochen Mainz, MD

Role: CONTACT

+49 3641 938425

Facility Contacts

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Jochen Mainz, MD

Role: primary

+49 3641 938425

References

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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.

Reference Type BACKGROUND
PMID: 22890694 (View on PubMed)

Mainz 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.

Reference Type BACKGROUND
PMID: 22045752 (View on PubMed)

Mainz 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.

Reference Type BACKGROUND
PMID: 22133899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19282318 (View on PubMed)

Other Identifiers

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CF_Sinusitis_LS

Identifier Type: -

Identifier Source: org_study_id

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