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

NCT00803881 | Unknown

• 1 other identifier: CF_Sinusitis_LS
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis With Other Manifestations; Sinusitis

Outcome Measures

Primary Outcomes (2)

• Dynamics in CF upper and lower airway colonization with pathogens

  longitudinal non-invasive sampling of upper and lower airways in CF

  10 years

• Assessment of ability to smell in CF patients

  3 years

Secondary Outcomes (1)

• pulmonary function / BMI

  10 years

Study Arms (1)

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

Other: nasal lavage and sputum collection

Interventions

nasal lavage and sputum collection OTHER

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

Also known as: Pseudomonas aeruginosa antibodies in serum

CF patients of all age groups

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients of the CF outpatients clinic and hospitalized CF patients

You may qualify if:

• Subject has a confirmed diagnosis of cystic fibrosis

Sponsors & Collaborators

• University of Jena: lead

Study Sites (1)

University of Jena - CF-Center

Jena, 07740, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 22890694 BACKGROUND

• 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.

  PMID: 22045752 BACKGROUND

• 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.

  PMID: 22133899 BACKGROUND

• 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: 19282318 BACKGROUND

MeSH Terms

Conditions

Sinusitis

Interventions

Nasal Lavage

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Jochen Mainz, MD

  University of Jena - CF Center

  STUDY CHAIR

Central Study Contacts

Jochen Mainz, MD

CONTACT

+49 3641 938425; Jochen.Mainz@med.uni-jena.de

Study Design

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

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

DE (1)