Trial Outcomes & Findings for Impact of Symbiofilm On Nasal Microbiota (NCT NCT05015530)
NCT ID: NCT05015530
Last Updated: 2024-11-08
Results Overview
Comparaison of the values of alpha diversity of bacterial species assessed by the Shannon index at baseline and after the treatment period
Recruitment status
COMPLETED
Target enrollment
12 participants
Primary outcome timeframe
At baseline (V1) and at end of the 30-day treatment period (V2)
Results posted on
2024-11-08
Participant Flow
The subjects will be recruited by the site among outpatients coming for routine consultation because of CRS. The first patient was screened and enrolled on 12th December 2022, the last patient was screened and enrolled on 25th April 2023.
Participant milestones
| Measure |
Healsea® Chronic: Hypertonic Seawater-Based Nasal Spray With Natural Symbiofilm® Extract
Healsea® Chronic nasal spray will be administered twice a day (1 puff, 1-2 sec) in each nostril during 30 days.
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|---|---|
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Overall Study
STARTED
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12
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|
Overall Study
Safety Set
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12
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Overall Study
Full Analysis Set (FAS)
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12
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Overall Study
Per Protocol Set (PP)
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3
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Overall Study
COMPLETED
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12
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Symbiofilm On Nasal Microbiota
Baseline characteristics by cohort
| Measure |
Healsea® Chronic: Hypertonic Seawater-Based Nasal Spray With Natural Symbiofilm® Extract
n=12 Participants
Healsea® Chronic nasal spray will be administered twice a day (1 puff, 1-2 sec) in each nostril during 30 days.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants
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Age, Categorical
>=65 years
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2 Participants
n=5 Participants
|
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Age, Continuous
|
43.5 years
STANDARD_DEVIATION 13 • n=5 Participants
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Sex: Female, Male
Female
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11 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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12 Participants
n=5 Participants
|
|
Region of Enrollment
France
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12 participants
n=5 Participants
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Baseline SNOT-22 (total)
|
59.3 score on a scale
STANDARD_DEVIATION 21.2 • n=5 Participants
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α diversity
|
2.041 Shannon Index
STANDARD_DEVIATION 0.900 • n=5 Participants
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PRIMARY outcome
Timeframe: At baseline (V1) and at end of the 30-day treatment period (V2)Population: Full Analysis Population
Comparaison of the values of alpha diversity of bacterial species assessed by the Shannon index at baseline and after the treatment period
Outcome measures
| Measure |
Healsea® Chronic Baseline Value
n=12 Participants
Shannon index before administration of Healsea® Chronic
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Healsea® Chronic After 30-day Treatment
n=12 Participants
Shannon index after administration of Healsea® Chronic twice a day (1 puff, 1-2 sec) in each nostril during 30 days.
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|---|---|---|
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Comparaison of Alpha-diversity of Sino-nasal Microbiota Before and After Treatment (Visit 1 and Visit 2)
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2.041 Shannon Index
Standard Deviation 0.900
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2.114 Shannon Index
Standard Deviation 1.041
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SECONDARY outcome
Timeframe: End of treatment (Visit 2(V2)-Day 30) versus screening/inclusion (Visit 1(V1)-Day 1)Population: Full Analysis Population
Change of SNOT-22 total score at the end of the 30-day treatment period versus baseline . A change \>-9 is deemed clinically meaningful.
Outcome measures
| Measure |
Healsea® Chronic Baseline Value
n=12 Participants
Shannon index before administration of Healsea® Chronic
|
Healsea® Chronic After 30-day Treatment
n=12 Participants
Shannon index after administration of Healsea® Chronic twice a day (1 puff, 1-2 sec) in each nostril during 30 days.
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|---|---|---|
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Impact of Healsea® Chronic on Quality of Life Assessed by the Sino-Nasal Outcome Test Score-22
Absolute values of SNOT-22 total score
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59.3 score on a scale
Standard Deviation 21.2
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41.8 score on a scale
Standard Deviation 25.5
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Impact of Healsea® Chronic on Quality of Life Assessed by the Sino-Nasal Outcome Test Score-22
Change of SNOT-22 total score versus baseline
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0 score on a scale
Standard Deviation 0
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-17.5 score on a scale
Standard Deviation 17
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SECONDARY outcome
Timeframe: Visit 2(V2)-Day 30 (end of treatment)Population: Full Analysis Population
To assess patient 's satisfaction regarding the medical device usability
Outcome measures
| Measure |
Healsea® Chronic Baseline Value
n=12 Participants
Shannon index before administration of Healsea® Chronic
|
Healsea® Chronic After 30-day Treatment
Shannon index after administration of Healsea® Chronic twice a day (1 puff, 1-2 sec) in each nostril during 30 days.
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|---|---|---|
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Patient Satisfaction Questionnaire (Usability)
Missing
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0 Participants
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—
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Patient Satisfaction Questionnaire (Usability)
Not easy
|
0 Participants
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—
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Patient Satisfaction Questionnaire (Usability)
Pretty easy
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0 Participants
|
—
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Patient Satisfaction Questionnaire (Usability)
Easy
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0 Participants
|
—
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Patient Satisfaction Questionnaire (Usability)
Very easy
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12 Participants
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—
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SECONDARY outcome
Timeframe: Visit 2(V2)-Day 30 (end of treatment)Population: Full Analysis Population
To assess patient 's satisfaction regarding the sensory perception (residual taste after spraying)
Outcome measures
| Measure |
Healsea® Chronic Baseline Value
n=12 Participants
Shannon index before administration of Healsea® Chronic
|
Healsea® Chronic After 30-day Treatment
Shannon index after administration of Healsea® Chronic twice a day (1 puff, 1-2 sec) in each nostril during 30 days.
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|---|---|---|
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Patient Satisfaction Questionnaire (Taste)
Missing
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0 Participants
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—
|
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Patient Satisfaction Questionnaire (Taste)
Not pleasant
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0 Participants
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—
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Patient Satisfaction Questionnaire (Taste)
Neutral
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8 Participants
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—
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Patient Satisfaction Questionnaire (Taste)
Pleasant
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3 Participants
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—
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Patient Satisfaction Questionnaire (Taste)
Very pleasant
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1 Participants
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—
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SECONDARY outcome
Timeframe: Visit 2(V2)-Day 30 (end of treatment)Population: Full Analysis Population
To assess patient 's satisfaction regarding product efficacy for chronic Rhinosinusitis (Cleansing and Moistening of nasal mucosa)
Outcome measures
| Measure |
Healsea® Chronic Baseline Value
n=12 Participants
Shannon index before administration of Healsea® Chronic
|
Healsea® Chronic After 30-day Treatment
Shannon index after administration of Healsea® Chronic twice a day (1 puff, 1-2 sec) in each nostril during 30 days.
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|---|---|---|
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Patient Satisfaction Questionnaire (Efficacy)
Missing
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0 Participants
|
—
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Patient Satisfaction Questionnaire (Efficacy)
No improvement
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0 Participants
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—
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Patient Satisfaction Questionnaire (Efficacy)
Slight improvement
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2 Participants
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—
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Patient Satisfaction Questionnaire (Efficacy)
Moderate improvement
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6 Participants
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—
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Patient Satisfaction Questionnaire (Efficacy)
Very clear improvement
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4 Participants
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—
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OTHER_PRE_SPECIFIED outcome
Timeframe: During the intervention, up to 30 daysAssessment of materiovigilance from the medical device (incidents, expected side effects) and reporting of adverse reactions related to the additional invasive procedure (swab of the nasal meatus)
Outcome measures
Outcome data not reported
Adverse Events
Healsea® Chronic: Hypertonic Seawater-Based Nasal Spray With Natural Symbiofilm® Extract
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healsea® Chronic: Hypertonic Seawater-Based Nasal Spray With Natural Symbiofilm® Extract
n=12 participants at risk
Healsea® Chronic nasal spray will be administered twice a day (1 puff, 1-2 sec) in each nostril during 30 days.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
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16.7%
2/12 • Number of events 2 • Adverse events/incidents were collected during the intervention and up to 30 days
In this investigation with a medical device, 3 types of adverse events were to be reported: non-related/related adverse events and serious adverse events related to the invasive procedure. No SAE has been reported. Also, materiovigilance from the medical device (incidents, expected side effects) was to be reported. One incident was reported: Headache (Nervous system disorders).
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Gastrointestinal disorders
Mouth ulceration
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8.3%
1/12 • Number of events 1 • Adverse events/incidents were collected during the intervention and up to 30 days
In this investigation with a medical device, 3 types of adverse events were to be reported: non-related/related adverse events and serious adverse events related to the invasive procedure. No SAE has been reported. Also, materiovigilance from the medical device (incidents, expected side effects) was to be reported. One incident was reported: Headache (Nervous system disorders).
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Gastrointestinal disorders
Palatal disorder
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8.3%
1/12 • Number of events 1 • Adverse events/incidents were collected during the intervention and up to 30 days
In this investigation with a medical device, 3 types of adverse events were to be reported: non-related/related adverse events and serious adverse events related to the invasive procedure. No SAE has been reported. Also, materiovigilance from the medical device (incidents, expected side effects) was to be reported. One incident was reported: Headache (Nervous system disorders).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60