Unspecified Disorder of Nose and Nasal SinusesNCT03251066
Immediate Effect of Proponent-Nasal-Spray on Unspecific Discomfort in the Nose
A study testing Proponent Nasal Spray in people with Unspecified Disorder of Nose and Nasal Sinuses, run by PRECLIN Biosystems AG at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Unspecified Disorder of Nose and Nasal Sinuses
- What is being tested?
- Proponent Nasal Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Apr 2017to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <18 years of age
- 75 years of age
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie University Zürich
Zurich, Canton of Zurich, 8091
About this study
Official 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
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.
Read the 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.
- Being tested
- Proponent Nasal Spray
- Keywords
- Nose Saline Solution Irrigation Nasal Spray, Sodium propionate Locke-Ringer Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proponent Nasal SprayOther
The medical device consists of a Saline solution containing sodium propionate which is administered as single dose
| Study group | Role | What they receive |
|---|---|---|
| Test group | Other | Proponent Nasal Spray Medical device Receives: Other: Proponent Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 48 hrs
Secondary outcomes (1)
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.
Measured: up to 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start27 Apr 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unspecified Disorder of Nose and Nasal SinusesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- PRECLIN Biosystems AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soyka Michael, MD, Principal investigator, ORL, USZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251066
- Sponsor's protocol ID
- PNSY2
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24390308Brandtzaeg P. Immune functions of nasopharyngeal lymphoid tissue. Adv Otorhinolaryngol. 2011;72:20-4. doi: 10.1159/000324588. Epub 2011 Aug 18.
PubMed 21865681Achilles 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.
PubMed 23354530
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03251066
- Acronym / sponsor ID
- PNSY2
- Keywords
- Nose Saline Solution Irrigation Nasal Spray, Sodium propionate Locke-Ringer Solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- PRECLIN Biosystems AGIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test group | Other | Other: Proponent Nasal SprayProponent Nasal Spray Medical device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- nasal discharge/ secretion (runny nose)
- congested nose
- sneezing
- itchy nose
- feeling of a dry nose
Key exclusion criteria (2 listed)
- <18 years of age
- 75 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proponent Nasal SprayThe medical device consists of a Saline solution containing sodium propionate which is administered as single dose | Other | Test group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Results publication: PubMed 24390308Trompette 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.
- Results publication: PubMed 21865681Brandtzaeg P. Immune functions of nasopharyngeal lymphoid tissue. Adv Otorhinolaryngol. 2011;72:20-4. doi: 10.1159/000324588. Epub 2011 Aug 18.
- Results publication: PubMed 23354530Achilles 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soyka Michael, MD principal investigator
ORL, USZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proponent Nasal Spray in people with Unspecified Disorder of Nose and Nasal Sinuses, run by PRECLIN Biosystems AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the safety endpoint (adverse events non-response rate). (time frame: up to 48 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251066, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.