Open, Not Randomised, Non-blinded Observation Study to Investigate the Immediate Effect of Proponent - Nasal - Spray in Case of Unspecific Discomfort in the Nose
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Unspecified Disorder of Nose and Nasal Sinuses
- Sponsor
- PRECLIN Biosystems AG
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- The primary endpoint is the safety endpoint (adverse events non-response rate).
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Key inclusion criteria are one or more of the following symptoms:
- •nasal discharge/ secretion (runny nose)
- •congested nose
- •itchy nose
- •feeling of a dry nose
Exclusion Criteria
- •Key exclusion criteria:
- •\<18 years of age
- •75 years of age
Outcomes
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".(up to 48 hrs)