Trial | NCT03251066  Report issue

Title

Immediate Effect of Proponent-Nasal-Spray on Unspecific Discomfort in the Nose
Open, Not Randomised, Non-blinded Observation Study to Investigate the Immediate Effect of Proponent - Nasal - Spray in Case of Unspecific Discomfort in the Nose

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    54
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.
Study Started
Apr 27
2017
Primary Completion
Jun 30
2017
Study Completion
Jun 30
2017
Last Update
Aug 21
2017

Other Proponent Nasal Spray

The medical device consists of a Saline solution containing sodium propionate which is administered as single dose

Test group Other

Proponent Nasal Spray Medical device

Criteria 

Inclusion Criteria:

Key inclusion criteria are one or more of the following symptoms:

nasal discharge/ secretion (runny nose)
congested nose
sneezing
itchy nose
feeling of a dry nose

Exclusion Criteria:

Key exclusion criteria:

<18 years of age
75 years of age
No Results Posted