Immediate Effect of Proponent-Nasal-Spray on Unspecific Discomfort in the Nose

PRECLIN Biosystems

Status: Completed

Conditions: Unspecified Disorder of Nose and Nasal Sinuses

Treatments: Other: Proponent Nasal Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT03251066

PNSY2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Test group

Other group

Description:

Proponent Nasal Spray Medical device

Treatment:

Other: Proponent Nasal Spray