Immediate Effect of Proponent-Nasal-Spray on Unspecific Discomfort in the Nose
NCT ID: NCT03251066
Last Updated: 2017-08-21
Study Results
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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COMPLETED
NA
54 participants
INTERVENTIONAL
2017-04-27
2017-06-30
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Test group
Proponent Nasal Spray Medical device
Proponent Nasal Spray
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
Eligibility Criteria
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Inclusion Criteria
* congested nose
* sneezing
* itchy nose
* feeling of a dry nose
Exclusion Criteria
* 75 years of age
18 Years
75 Years
ALL
Yes
Sponsors
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PRECLIN Biosystems AG
INDUSTRY
Responsible Party
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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
Countries
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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.
Brandtzaeg P. Immune functions of nasopharyngeal lymphoid tissue. Adv Otorhinolaryngol. 2011;72:20-4. doi: 10.1159/000324588. Epub 2011 Aug 18.
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.
Other Identifiers
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PNSY2
Identifier Type: -
Identifier Source: org_study_id
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