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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251066
• Other study ID #: PNSY2
• Status: Completed
• Phase: N/A
• First received: August 7, 2017
• Last updated: August 16, 2017
• Start date: April 27, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2017
• Source: PRECLIN Biosystems AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Nose Diseases
• Unspecified Disorder of Nose and Nasal Sinuses

Intervention

Other:
• Proponent Nasal Spray
The medical device consists of a Saline solution containing sodium propionate which is administered as single dose

Locations

Country	Name	City	State
Switzerland	Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie University Zürich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
PRECLIN Biosystems AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Achilles N, Mösges 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. Review. — View Citation

Brandtzaeg P. Immune functions of nasopharyngeal lymphoid tissue. Adv Otorhinolaryngol. 2011;72:20-4. doi: 10.1159/000324588. Epub 2011 Aug 18. — View 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):1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the safety endpoint (adverse events non-response rate).	This endpont is defined by the adverse events non-response rate based on the individual adverse events reported by the participant up to 60 min after treatment. The adverse events are specified and defined by scores. The sum score over time for all individual adverse event symptoms will be determined for each participant. Not more than 10 % of all participants of the study should report adverse events with a sum score > 3 for one or more of the listed adverse events. Not more than 10 % of all participants of the study should report adverse events with a sum score > 3 for one or more of the listed adverse effects.	up to 48 hrs
Secondary	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".	The first co-secondary endpoint of the study is the immediate response rate based on the "Change of severity of general symptoms of unspecific nasal discomfort" following the single administration of "Proponent Nasal Spray" up to 60 min after treatment. The second co-secondary endpoint is the immediate response rate based on the "Change of severity of selected individual symptoms" of nasal discomfort following the single administration of "Proponent Nasal Spray" up to 60 min after treatment - provided the respective symptom was identified by a participant prior to the administration of "Proponent Nasal Spray" as a nasal discomfort.	up to 48 hrs