Respiratory clinical trials

Conducting early-phase and proof-of-concept

Leveraging our excellent medical and academic expertise, we are committed to supporting clients with the development of drugs targeting allergy and respiratory diseases and to conducting patient-oriented research that helps people suffering from these conditions.

We are a highly specialized, academia-affiliated research unit for early-phase and proof-of-concept clinical trials. Our focus is on airway diseases such as asthma, allergic rhinitis, COPD, and interstitial lung diseases, in particular idiopathic pulmonary fibrosis. We conduct trials with our highly qualified and dedicated team of physicians, study nurses, project managers, and medical documentation specialists, accompanied by an independent quality assurance unit. We offer a broad range of challenge models for our studies. With our strong academic background we support our clients in finding the proof-of concept model and study design best suited to their particular requirements.

Thanks to our extensive experience in clinical research, we will always find the optimal model and design for your proofof-concept study.

Our services and expertise

Clinical Research Center Hannover (CRC Hannover):

  • State-of-the-art facility
  • 6000 m2 of floor space
  • 24/7 operations
  • 30 intensive-monitoring beds (for clinical trials of phases I and IIa)
  • 20 beds for study participants not requiring intensive monitoring
  • 15 rooms for special diagnostics
  • Outpatient section for screening visits
  • Facilities for study participants, incl. cinema, gym, and cafeteria
  • Ability to house study participants for several weeks
  • Telemetric observation
  • Attendance of an anesthesiologist when required by protocol
  • Full set of emergency equipment and medication 

Fraunhofer Allergen Challenge Chambers:
Four challenge chambers for proof-of-concept studies with sophisticated study designs, using natural pollen (grass, birch), allergen extracts (e.g. cat, house dust mite), or ozone.   

Inhaled allergen challenge:
Induction of early and late-phase asthmatic reactions in patients with asthma, enabling efficacy testing of novel asthma treatments. A German multicenter network with the same high quality level across all participatory sites is available for expedited recruitment.

Segmental challenge by bronchoscopy:
Localized pulmonary inflammation (endotoxin, allergen) for the assessment of anti-inflammatory drugs or sampling of human material (under well-defined conditions).

Exercise testing (ergospirometry):
Ergospirometry for efficacy testing of bronchodilators in patients with COPD.

Biobank:
Blood samples, cells, and lung tissue collected according to standardized procedures from well-characterized patients can be used for validation of drug candidates. Biological materials can be stored in our biobank at ultra-low temperatures.

Biomarker analysis:
Analysis of a wide range of biomarkers from blood, sputum, and lavage fluid in our state-of-the-art immunological laboratory (incl. flow cytometry, chip cytometry, MSD multiplex platform). Standardized induced sputum sampling and processing allows centralized analyses in multicenter trials that guarantee the highest level of quality.

Imaging: 
Non-invasive MRI techniques for quantitative assessment of pulmonary inflammation.

GMP unit: 
Handling of investigational medicinal products and production of final intravenous dosage forms in our in-house GMP unit.

Patient/volunteer database and professional recruitment:
Large database of pre-screened patients and healthy volunteers and a professional recruitment unit guarantee rapid recruitment and reliable timelines in our clinical trials.

 

Your benefits

© Photo Fraunhofer ITEM

Segmental endotoxin challenge: Instillation of endotoxin (LPS) into defined lung segments during bronchoscopy allows efficacy testing of new drugs, e.g. for COPD treatment.

Early-phase and proof-of-concept unit for airway diseases with unique infrastructure

Broad range of challenge models

Innovative diagnostics

Academic expertise

Customized testing strategies for earlyphase trials

Scientific synergies of in-house GMP production of investigational medicinal products, pre-clinical testing, and toxicology