Our Rhinitis Models

Allergen Chambers

Proprietary methods of allergen distribution ensure full dilution into the air, mitigating failures caused by inconsistent allergen exposure in studies. The air pollen mixture becomes homogenous before inlet into room, and the air has the ability to force particles toward the perimeter of the room. The pollen then leaves the air stream and descends to the exhaust at the bottom.

In order to meet the demands of the particular stages of drug development, we have built and validated numerous chamber configurations.

Inside the Allergen BioCude

We have controlled environments that are ideal for Proof of Concept, Observational, and Phase IV marketing studies. These models can quickly highlight the efficacy of a proven therapeutic like Flonase.

We also have higher-capacity systems that are ideal for integration into multi-center Phase III programs, Onset of Action & Duration of Action Studies and High Throughput Screening.

In addition to our stationary platforms we also have the ability to conduct multi-center studies by employing our Mobile systems.

Nasal Allergen Challenge (NAC)

Ora's standardized NAC processes include the diluation of allergen formulations and titration to ensure safe, precise, and reproducible instillation of allergen directly to the nasal mucosa to allow for standardization across study sites.

Nasal Allergen Challenge (NAC)

Up to ten different concentrations of allergen are applied to the nasal mucosa in order to replicate the level of reaction observed in the environment during an allergic response. The reaction caused by the NAC is subjectively scored by study subjects, in conjunction with clinician-graded objective measures including nasal mucosa inflammation, PEFR and PNIF.

Enviro-NAC

Ragweed

Environmental/Field studies have been the standard for the approval of allergic rhinitis therapies. In order to enrich the study population with subjects that are demonstrated to be highly sensitive to the specific allergen(s) being studied, knowing the relative sensitivity of the study subjects is crucial. The utilization of the NAC as a screening tool in environmental studies is an essential component in the development of allergen specific immunotherapies.

Nasal Inflammation Scale (NIS)

Nasal Inflammation Scale (NIS)

Objective measurements such as the NIS provide quantifiable measurements, thus reducing patient bias and ensuring a visibly moderate level of disease. Within the screened patient population the NIS is correlated with PNIF and symptomatology scores. The NIS can be incorporated as an objective endpoint in controlled environments, NAC, and traditional environmental protocols.

Total Clinical Services
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Ora offers a full suite of development services along every step of the development pathway. Our consulting and capital services will help you better identify optimal target indications, establish market evaluations, and determine capital needs. Our formulation, preclinical, and clinical trial services encompass full project management support, consultation with formulation experts, a variety of disease and efficacy models, and complete study management, study conduct, and support for phase 1-4 trials.