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Fraunhofer Sputum Core Facility

Our experienced sputum center offers centralized organization and analysis to achieve optimal results for sputum analysis in multicenter clinical trials.

We guarantee the best choice of sputum methodology to fulfill the requirements of a particular trial. We offer study-specific training, supervision of quality during study conduct, and analysis of a broad spectrum of biomarkers.

SERVICE AND SUPPORT

  • Scientific input for optimal study design
  • Assistance in sputum marker selection
  • Sputum method setup – lab manual/SOPs
  • On-site or centralized sputum training workshops for participating sites
  • Continued QC of samples during the study
  • Organization of sample shipment and storage
  • Centralized sputum analysis
    • Cellular sputum composition (incl. FACS)
    • Sputum fluid-phase biomarkers (ELISA, MSD)
    • ChipCytometry
    • Gene expression
    • Metabolomics (BIOKRATES)
  • Data report/publication

EXPERIENCE AND INFRASTRUCTURE

  • Experienced scientific staff
    • Over 30 papers and reviews on sputum methodology and application
    • Consultants to pharmaceutical industry in non-invasive airway monitoring
    • Member of sputum taskforce
    • Trainer for multicenter sputum trials since 2001
  • Experienced nurse team and technical staff
    • Numerous clinical trials with sputum analysis
    • Routinely performed sputum induction
  • SOP-guided sputum induction and processing
  • Extensive experience with sponsor-specific sputum protocols
  • Method development and validation of novel biomarkers incl. ChipCytometry
  • GCP-compliant

References

Sputum taskforce document:

Paggiaro PL, Chanez P, Holz O, Ind PW, Djukanović R, Maestrelli P, Sterk PJ. Sputum induction. Eur Respir J Suppl. 2002

Sputum clinical trials

Holz O, Biller H, Mueller M, Kane K, Rosano M, Hanrahan J, Hava DL, Hohlfeld JM. Efficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model–a clinical trial. BMC Pharmacol Toxicol. 2015

Janssen O, Schaumann F, Holz O, Lavae-Mokhtari B, Welker L, Winkler C, Biller H, Krug N, Hohlfeld JM. Low-dose endotoxin inhalation in healthy volunteers—a challenge model for early clinical drug development. BMC Pulm Med. 2013

Röpcke S, Holz O, Lauer G, Müller M, Rittinghausen S, Ernst P, Lahu G, Elmlinger M, Krug N, Hohlfeld JM. Repeatability of and relationship between potential COPD biomarkers in bronchoalveolar lavage, bronchial biopsies, serum, and induced sputum. PLoS One. 2012; 7 (10)

Holz O, Khalilieh S, Ludwig-Sengpiel A, Watz H, Stryszak P, Soni P, Tsai M, Sadeh J, Magnussen H. SCH527123, a novel CXCR2 antagonist, inhibits ozone-induced neutrophilia in healthy subjects. Eur Respir J. 2010

 Sputum methodology and challenge studies

Biller H, Holz O, Windt H, Koch W, Müller M, Jörres RA, Krug N, Hohlfeld JM. Breath profiles by electronic nose correlate with systemic markers but not ozone response. Respir Med. 2011

Holz O, Tal-Singer R, Kanniess F, Simpson KJ, Gibson A, Vessey RS, Janicki S, Magnussen H, Jörres RA, Richter K. Validation of the human ozone challenge model as a tool for assessing anti-inflammatory drugs in early development. J Clin Pharmacol. 2005 May; 45 (5) :498-503. PubMed PMID: 15831772

Holz O, Mücke M, Paasch K, Böhme S, Timm P, Richter K, Magnussen H, Jörres RA. Repeated ozone exposures enhance bronchial allergen responses in subjects with rhinitis or asthma. Clin Exp Allergy. 2002

Contact
Dr. Meike Müller
Fraunhofer ITEM
Biomarker Analysis
Phone +49 511 5350-8144
Send an e-mail