Respiratory

Respiratory clinical trials conception to completion, during this process we provide specialised expertise and facilities to carry out cutting edge clinical research.

Experience & Expertise

Environmental Exposure Chambers (EECs)

A Natural & Controlled Allergen Challenge Model

Natural allergen Environmental Exposure Chambers (EECs) are state-of-the-art facilities that tightly regulate temperature and humidity, while simulating the level of allergen exposure patients would encounter in their everyday lives.

Our EECs represents the next generation in EEC technologies in which allergen exposure is highly specific, accurate, and precise, thus improving research outcomes in allergy development. The EEC provides uniform airborne allergen distribution across the patient seating and peripheral areas. By monitoring patients throughout the exposure period, compliance is ensured and nasal, bronchial, and ocular signs and symptoms may be evoked consistently and safely.

To combine the advantages of the EEC with the necessity to conduct large, geographically diverse phase III trials, Cliantha has developed mobile EEC (mEEC™) technology. mEECs™ are validated to the same rigorous standards as our fixed EECs, and provide the versatility to have multiple, identical mEECs across a multicentre study. This allows for a better or clinically symptomatic patient to be enrolled.

The mEEC^TM approach is perfect for the study of allergen-specific therapies where it can be difficult, even impossible, to study one allergy in isolation of other interfering allergies.

Advantages of Natural Allergen EECs

The design of proprietary allergen models focuses on delivering uniform and reproducible allergen exposure. The EEC allows many advantages to the traditional field model by providing a large variety of study types and clinical endpoints to be investigated.

• Ability to mimic seasonal allergen exposure for trees, grasses, and ragweed; and perennial allergens such as cat and house dust mite at any time of the year
• Screen and enroll truly symptomatic subjects shown by ePRO and clinical monitoring
• Proof of Concept, Mechanism of Action, comparator and dose ranging studies
• Adaptive combination PK/PD and clinical endpoint
• Hybrid EEC and field studies with consistent ePRO data collection
• Biomarker analysis of nasal secretions, sputum, impression cytology or tear samplingr
• Specialized quantitative endpoint studies with validated objective measures such as nasal patency through acoustic rhinometry
• Study Non-Allergic Rhinitis in EEC using Cold-Dry Air, Fragrance, and Ozone as provocateurs.
• Mild, Moderate, or Severe asthma
• Study Healthy Normal Volunteers in EEC using Ozone towards COPD POC and MOA studies
• Continuous lung function monitoring through validated and integrated ePRO devices

Cliantha Research, provides consultation services to make sure your study design, endpoints, biomarkers, and qualitative and quantitative methods achieves the desired outcomes when approaching regulatory authorities worldwide.