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

NCT ID: NCT03251066

Last Updated: 2017-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-27

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Unspecified Disorder of Nose and Nasal Sinuses

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test group

Proponent Nasal Spray Medical device

Group Type OTHER

Proponent Nasal Spray

Intervention Type OTHER

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

Interventions

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Proponent Nasal Spray

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \<18 years of age
* 75 years of age
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PRECLIN Biosystems AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Soyka Michael, MD

Role: PRINCIPAL_INVESTIGATOR

ORL, USZ

Locations

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Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie University Zürich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 24390308 (View on PubMed)

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

Reference Type RESULT
PMID: 21865681 (View on PubMed)

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.

Reference Type RESULT
PMID: 23354530 (View on PubMed)

Other Identifiers

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PNSY2

Identifier Type: -

Identifier Source: org_study_id

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