Completed

NCT Number: NCT03251066

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

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.

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Key information

Conditions

Unspecified Disorder of Nose and Nasal Sinuses

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proponent Nasal Spray

Other

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

Primary outcomes

The primary endpoint is the safety endpoint (adverse events non-response rate).

Time frame: up to 48 hrs

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.

Secondary outcomes

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".

Time frame: up to 48 hrs

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.

Sponsors and collaborators

Lead sponsor

PRECLIN Biosystems AG

Industry

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Aug 16, 2017
Registry last updated: Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.