Special Examinations
Medaimun specializes in the following time-consuming and complex examinations:
Overview of our special examinations
Allergen provocation
Bronchial allergen challenge
Conjunctival, nasal, and bronchial allergen provocations are primarily used in "Proof of Concept" studies as the main success parameter.
Conjunctival and nasal allergen provocations are established methods for dose determination in specific immunotherapy. Bronchial allergen challenge is less well-established. The allergen solution is nebulized using a Medic Aid nebulizer and administered with the help of the Aerosol Provocation System APS® (VIASYS Healthcare GmbH, Hoechberg, Germany). Specific bronchial hyperreactivity (BHR) is defined by the cumulative dose of the allergen at which the FEV1 drops by 20% compared to the baseline value (PD20FEV1). The provocation can be performed as a single-step or multi-step challenge.
(Schulze et al., 2011) Download
Low-dose allergen challenge
This method is based on the inhalation of a low dose of allergen that triggers a 5% decrease in FEV1 (PD5FEV1). The method is ideal for generating an inflammatory situation through repeated allergen exposure. The low-dose allergen provocation model is a perfect tool for studying anti-inflammatory drugs and substances, such as functional foods.
(Schubert et al., 2009) Download
High-dose allergen challenge
The high-dose allergen provocation is a newly established method in Frankfurt, where subjects are repeatedly exposed to allergens (4 provocations of PD20FEV1 within one week). This provocation not only leads to changes in lung function (decrease in FEV1) but also triggers asthmatic symptoms. The high-dose allergen challenge can only be conducted under partial inpatient monitoring of the patients.
(Schulze et al., 2012) Download
LPS-induced inflammation
Inhalation of bacterial endotoxin and its derivative LPS induces a significant inflammatory response. Experimental LPS inhalation is a well-established method in the study of inflammatory processes. As we have recently shown, LPS inhalation is a safe and tolerable procedure for studying inflammation in humans (Human bronchitis model).
Medaimun developed its own IMPD for LPS in 2013 and applied the bronchitis model in a study titled "Clinical and Immunological Efficacy of Broncho-Vaxom (BV) in the LPS Bronchitis Model in Healthy Volunteers. A Randomized, Double-Blind, Parallel-Group Study" with 60 healthy subjects.
The LPS provocation was well tolerated, and as expected, it led to a mild systemic and bronchial inflammation.
Literature
1. Kitz R, Rose MA, Borgmann A, Schubert R, Zielen S. Systemic and bronchial inflammation following LPS inhalation in asthmatic and healthy subjects.
J Endotoxin Res. 2006;12(6):367-74. Download
2. Kitz R, Rose MA, Placzek K, Schulze J, Zielen S, Schubert R. LPS inhalation challenge: a new tool to characterize the inflammatory response in humans.
Med Microbiol Immunol. 2008 Mar;197(1):13-9. Download
Serial lung function measurement
Medaimun has an inpatient unit and has participated as a study site in various overnight studies (Phase II) involving serial lung function measurements and pharmacokinetic studies.
Medaimun has two very nice overnight rooms and a state-of-the-art lung function measurement device.
Sputum examinations
Medaimun is a sputum expert. Induced sputum is an important procedure for more accurately characterizing bronchial inflammation. An accredited in-house laboratory has specialized expertise in the collection and processing of induced sputum.
Laboratory investigations
The certified laboratory, with its specialized medical technical assistants (MTAs), offers a wide range of immunological and allergological test systems, including in vitro diagnostics, cell culture systems, and mouse models. We provide laboratory services of the highest quality, offering a broad spectrum of ELISA techniques, cell and molecular technologies, PCR measurements, as well as flow cytometric analyses.
The laboratory is certified according to the ISO 9001:2000 standard.
In-Vitro Diagnostics
Medaimun offers a wide range of ELISA-based methods for investigating allergic and immunological questions and for the successful monitoring of clinical studies.
The in-vitro diagnostics include:
• Specific IgE, IgG, IgG4, total IgE, ECP
• PNC serotypes (5, 7, 9, 14, 18, 19, 23), Tetanus, HIB
• Secretory IgA in saliva
• IgG subclasses IgG1-IgG4
• Cytokines and Chemokines
• Leukotrienes and Prostaglandins
Cell culture systems
The laboratory has extensive experience with various cell culture systems and provides an excellent platform for allergological and immunological investigations.
The cell culture includes:
• B- and T-cell (subsets) isolations
• Basophil activation
• Proliferation/Apoptosis
• Protein phosphorylation
• Oxidative stress
