Unspecified Disorder of Nose and Nasal Sinuses Clinical Trial
Official title:
Open, Not Randomised, Non-blinded Observation Study to Investigate the Immediate Effect of Proponent - Nasal - Spray in Case of Unspecific Discomfort in the Nose
Investigation of the immediate effect on subjective relief of symptoms by Proponent - Nasal - Spray after a one time administration (following a single dose administration in each nostril) in an open, not randomised, non-blinded single centre observation study on 40 volunteers between 18-75 years of age with an unspecific discomfort in the nose such as enhanced nasal discharge/ secretion (runny nose), congested nose, sneezing, itchy nose or feeling of a dry nose.
By regularisation of environment of nasal mucosa and the following restitution and
improvement of the ciliary function the efficacy of mucociliary clearance can be remarkably
enhanced, pathogens from the environment can be physically removed and a bacterial or viral
infection may be prevented on this way.
Such an optimizing effect may be reached by the administration of an equilibrated saline
solution with an optimal composition regarding osmolality, pH-value and buffer substance.
In addition it would be very advantageous to support the efficacy of the local unspecific and
specific immune mechanisms in the nasal respiratory mucosa (NALT) without any negative
effects on the optimized mucociliary clearance.
As demonstrated recently in airway mucosa sodium propionate is able to interact with
macrophages, the interleukin system and other factors of the TNF receptor family.
Sodium propionate could therefore have an ancillary effect on the genuine immune mechanisms
of nasal respiratory mucosa. On this way the primary effect of administration of saline
solution is supported.
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