Clinical trial NCT03251066: Immediate Effect of Proponent-Nasal-Spray on Unspecific Discomfort in the Nose
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Disorder of Nose and Nasal Sinuses
Keywords: Nose Saline Solution Irrigation Nasal Spray
Sodium propionate Locke-Ringer Solution
Lead sponsor: PRECLIN Biosystems AG
Sponsor class: INDUSTRY
First posted: 2017-08-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Every participant of the study will specify at the beginning of the investigation his subjective starting situation concerning the nasal discomfort.The participant records his/ her personal impression on the change of severity of the general symptoms or selected individual symptoms of unspecific nasal discomfort following the single administration of "Proponent Nasal Spray". Every Patient serves as his own control.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: The primary endpoint is the safety endpoint (adverse events non-response rate).
timeFrame: up to 48 hrs
Secondary outcomes:
measure: The secondary endpoints of the study are the immediate response rate based on the "Change of severity of general and selected individual symptoms of unspecific nasal discomfort".
timeFrame: up to 48 hrs
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie University Zürich
state: ZH
Study officials:
affiliation: ORL, USZ
name: Soyka Michael, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trompette A, Gollwitzer ES, Yadava K, Sichelstiel AK, Sprenger N, Ngom-Bru C, Blanchard C, Junt T, Nicod LP, Harris NL, Marsland BJ. Gut microbiota metabolism of dietary fiber influences allergic airway disease and hematopoiesis. Nat Med. 2014 Feb;20(2):159-66. doi: 10.1038/nm.3444. Epub 2014 Jan 5.
citation: Brandtzaeg P. Immune functions of nasopharyngeal lymphoid tissue. Adv Otorhinolaryngol. 2011;72:20-4. doi: 10.1159/000324588. Epub 2011 Aug 18.
citation: Achilles N, Mosges R. Nasal saline irrigations for the symptoms of acute and chronic rhinosinusitis. Curr Allergy Asthma Rep. 2013 Apr;13(2):229-35. doi: 10.1007/s11882-013-0339-y.