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

Sinusitis Clinical Trial

Official title:

Prevalence of Chronic Rhinosinusitis, Pathogen-colonization in the Upper and Lower Airways and Ability to Smell in Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00803881
• Other study ID #: CF_Sinusitis_LS
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2008
• Last updated: October 24, 2016
• Start date: December 2008
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: University of Jena
• Contact: Jochen Mainz, MD
• Phone: +49 3641 938425
• Email: Jochen.Mainz[@]med.uni-jena.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subject has a confirmed diagnosis of cystic fibrosis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis With Other Manifestations
• Fibrosis
• Sinusitis

Intervention

Other:
• nasal lavage and sputum collection
non-invasive longitudinal assessment of pathogen colonization in both airway levels

Locations

Country	Name	City	State
Germany	University of Jena - CF-Center	Jena

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Mainz JG, Hentschel J, Schien C, Cramer N, Pfister W, Beck JF, Tümmler 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. — View Citation

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. — View Citation

Mainz JG, Naehrlich L, Schien M, Käding M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tümmler 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamics in CF upper and lower airway colonization with pathogens	longitudinal non-invasive sampling of upper and lower airways in CF	10 years	No
Primary	Assessment of ability to smell in CF patients		3 years	No
Secondary	pulmonary function / BMI		10 years	No