Clinical trials of a medical product in the Fraunhofer Allergen Challenge Chamber

Although there is a wide range of very effective hay fever drugs available, some sufferers would rather not rely on pharmacological substances. In terms of non-pharmacological treatment options, there are nasal gels and sprays that create a barrier, thus protecting the nasal mucosa from contact with allergens and reducing allergic symptoms in the nose.

The aim of this medicinal product study was to fulfill the American approval requirements for the barrier-forming nasal spray Bentrio® (which is approved for use in Europe) by comparing it with a barrier-forming nasal spray that has already been approved in the USA. To this end, 36 patients with hay fever and grass pollen allergies had their allergies triggered with grass pollen on two separate occasions seven days apart in the Fraunhofer Allergen Challenge Chamber. They did not receive any treatment prior to the first challenge. However, before the second challenge, half the participants were administered Bentrio®, while the other half were administered the reference product. During the challenge, the patients’ clinical symptoms were assessed every 20 minutes using the Total Nasal Symptom Score (TNSS), a self-reported symptom scale. Nasal secretions were measured hourly by weighing tissues, which the patients were instructed to use as needed.

The study showed that based on the TNSS and the amount of nasal secretions, there was no significant difference between the effectiveness of the two compounds. In a subjective overall evaluation, Bentrio® was rated higher than the reference product. As such, the product has fulfilled the requirements for approval in the USA.