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

Study Overview
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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.

Official Title
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Open, Not Randomised, Non-blinded Observation Study to Investigate the Immediate Effect of Proponent - Nasal - Spray in Case of Unspecific Discomfort in the Nose

Conditions
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Unspecified Disorder of Nose and Nasal Sinuses

Intervention / Treatment
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* Other: Proponent Nasal Spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test group<br>Proponent Nasal Spray Medical device | Other: Proponent Nasal Spray<br>* The medical device consists of a Saline solution containing sodium propionate which is administered as single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nose Saline Solution Irrigation Nasal Spray, Sodium propionate Locke-Ringer Solution