Asthma
Allergens Can Trigger Consistent Changes in Lung Function and Symptoms in Asthmatics. And We Can Precisely Control Low-Dose Allergen Exposure.
Cetero brings a uniquely powerful tool to asthma studies: our Environmental Exposure Chamber (EEC) model. It is a validated, rapid, safe and sensitive clinical solution for the development of small molecules, biologics, immunotherapies and medical devices.
Our environmental chambers have been custom engineered to meet precise air quality standards. For the conduct of clinical trials involving mild asthmatics, we introduce airborne asthma triggers in highly controlled low doses. Our chambers have been fully validated for safe patient exposure to ragweed, grass and tree pollens and cat and dust mite allergens.
We can provide a sustained low-dose challenge over successive days, replicating conditions patients encounter in their everyday lives, more naturally than standard nebulized high-dose bronchial challenges. Controlled natural allergen exposures in our chambers result in consistent changes in lung function and asthma symptoms that can be used as sensitive measures of anti-asthma drug efficacy.
We can customize asthma testing for other challenges such as exercise-induced and environmental challenges, including ozone. The chamber model can also be used to safely study the time to response and the level of response after prophylactic treatment in moderate to severe asthmatics.
Unlike field studies, chamber studies can be run at any time of the year with little variation in exposure.
Because asthma attacks are always uncomfortable and can be life threatening, we take extraordinary measures to ensure patient safety. The primary investigator reviews each study prior to start and determines the safety monitoring that will be in place for both on-site visits and during at-home periods. Investigators, medical associates, paramedics, respiratory technicians and nursing staff continuously monitor participants, both to ensure patient safety and to record symptoms rapidly and accurately.
In addition, we employ resuscitation equipment (“crash carts”), ACLS certified staff, and other equipment like spirometry and oxygen saturation in our safety monitoring plans. If needed, for home self-monitoring, we can use subject teaching, peak flow meters, and asthma action plans. Our investigator team is available 24/7 for subjects to call with any concerns.
The successful application of Cetero’s EEC technology results in asthma studies that are safer and faster, and detect clinical efficacy more sensitively than standard studies. The chamber model can be combined with our First to Proof-of-Concept service to significantly reduce the time to develop data and accelerate go/no go decisions.
