Back to resultsSafety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction (DEVALPO)
Primary Purpose
Acute Rhinitis, Nasal Obstruction, Rhinosinusitis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measurement of peak nasal flow.
Sponsored by
About this trial
This is an interventional treatment trial for Acute Rhinitis
Eligibility Criteria
Inclusion Criteria:
- 1. Patient ≥ 12 years.
- 2. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.
- 3. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient who has given assent and whose legal guardians have given written consent prior to any study-specific procedure.
- 4. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.
- 5. Patient affiliated to a social security scheme.
Exclusion Criteria:
- 1. Pregnant and/or breastfeeding woman
- 2. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray.
- 3. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and/or respiratory insufficiency.
- 4. Patients with chronic nasal obstruction.
- 5. Patients on local and systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics and local antiseptics.
- 6. Concomitant use of other nasal sprays, essential oils for local nasal use, nasal creams or gels.
- 7. Patients under guardianship, curatorship or safeguard of justice.
Sites / Locations
- Cabinet Médical CaenRecruiting
- Cabinet Médical Gainneville
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Arm A: Patients with peak nasal flow performed
Arm B: No peak nasal flow
Arm Description
This arm is made up of major patients. Nasal flow point measurements will be performed at D0 and D3.
This arm is made up of minor patients. Unlike arm A, nasal flow measurements will not be performed at D0 and D3.
Outcomes
Primary Outcome Measures
Performance of the Gilbert Laboratories pocket valve spray.
Proportion of patient presenting a change of the symptom "nasal obstruction" by at least 1 pt, in the SNOT22 Test (item 22), between Day 0 (at inclusion in the office before use of the spray) and Day 3 (in the evening after last daily use of the spray).
This item is scaled from 0 to 5, 5 being the worst value.
Secondary Outcome Measures
Change of nasal obstruction between Day 0 and Day 3
Proportion of patients with a change in Peak Inspiratory Nasal Flow value of at least 30 L/min between Day 0 (before use of the spray) and Day 3 (after use of the spray) (arm A).
[0 - 350 L/min] 350 L/min means a better outcome.
Immediate change of nasale obstruction at D0 on first use (Arm A)
Proportion of patients with a change in Peak Inspiratory Nasal Flow value of at least 30 L/min from pre- to post-spray measurements at Day 0 (arm A).
[ 0 - 350 L/min] 350 L/min means a better outcome.
Subjective feeling of reduced nasal obstruction on each day of use (arms A+B).
Proportion of patients with a reduction in the symptom "nasal obstruction" of at least 1pt, on SNOT22 (Sino-Nasal Outcome Test 22), and on each day of use (from Day 0 to Day 6) (arms A+B).
This item is scaled from 0 to 5, 5 being the worst value.
Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B).
Proportion of patients who experienced nasal cavity cleansing (feeling of freshness), on Patient Questionnaire, and on each day of use (from Day 0 to Day 6) (arms A+B).
Subjective feeling of nasal secretion thinning on each day of use (arms A+B).
Proportion of patients with a change in the symptom "thick nasal discharge" of at least 1pt, on SNOT22, and on each day of use (Day 0 to Day 6) (arms A+B).
This item is scaled from 0 to 5, 5 being the worst value.
Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use (arms A+B).
Proportion of patients who experienced relief of nasal (mucosal) irritation, on each day of use (Day 0 to Day 6) (arms A+B).
Subjective feeling of relief of nasal itching on each day of use (arms A+B).
Proportion of patients who experienced relief of nasal itching, on Patient Questionnaire, and on each day of use (Day 0 to Day 6) (arms A+B).
Speed of action at which the patient feels (subjectively) a decrease in nasal obstruction at D0 and D3 (arms A+B).
Proportion of patients with a change in immediate nasal obstruction after use of the spray, on Patient Questionnaire, at Day 0 and Day 3 (arms A+B).
Speed of action at which the patient feels (subjectively) a purification of his nasal cavities (sensation of freshness) at D0 and D3 (arms A+B).
Proportion of patients who experienced immediate nasal cleansing (feeling of freshness) after use of the spray at Day 0 and Day 3 (arms A+B).
Improvement in the patient's quality of life after 7 days of use (arms A+B).
Proportion of patients who experienced an improvement in quality of life, defined as an increase of at least 1pt on a scale of 0-10 between Day 0 and Day 6 (A+B arm).
10 mean a better value.
Patient satisfaction with the medical device after 7 days of use (arm A+B).
Proportion of patients satisfied with the medical device, on a 4-point scale, at Day 6 (arm A+B).
The better value is "very satisfied" and the worst value is "very unsatisfied".
Facility of use of the medical device after 7 days of use (arm A+B)
Proportion of patients who would recommend the medical device at Day 6 (arms A+B).
Evolution of the overall severity of symptoms (arm A+B).
Mean SNOT22 score on each day. Comparison of SNOT22 score at Day 3 versus Day 0 baseline (arms A+B).
[ 0 to 220 ] 0 is the better value.
All adverse events reported by patients using the pocket valve spray after 7 days of use (arm A+B).
All adverse events reported by the patient during the study (arm A+B).
Sensations of tingling and transient irritation (arms A+B).
Proportion of patients with at least 1 adverse event between 1st and last use of the medical device among the following adverse events (arms A+B):
Tingling sensations
Sensations of transient irritation
Full Information
NCT ID
NCT05494346
First Posted
August 5, 2022
Last Updated
June 23, 2023
Sponsor
Laboratoires Gilbert
Collaborators
EVAMED
1. Study Identification
Unique Protocol Identification Number
NCT05494346
Brief Title
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction
Acronym
DEVALPO
Official Title
Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Gilbert
Collaborators
EVAMED
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Rhinitis, Nasal Obstruction, Rhinosinusitis, Rhinopharyngitis, Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Patients with peak nasal flow performed
Arm Type
Other
Arm Description
This arm is made up of major patients. Nasal flow point measurements will be performed at D0 and D3.
Arm Title
Arm B: No peak nasal flow
Arm Type
No Intervention
Arm Description
This arm is made up of minor patients. Unlike arm A, nasal flow measurements will not be performed at D0 and D3.
Intervention Type
Device
Intervention Name(s)
Measurement of peak nasal flow.
Intervention Description
Peak nasal flow measurements will be performed before and after the first use of the spray at D0, as well as after the use of the spray at the medical office at D3 (only for arm A).
Primary Outcome Measure Information:
Title
Performance of the Gilbert Laboratories pocket valve spray.
Description
Proportion of patient presenting a change of the symptom "nasal obstruction" by at least 1 pt, in the SNOT22 Test (item 22), between Day 0 (at inclusion in the office before use of the spray) and Day 3 (in the evening after last daily use of the spray).
This item is scaled from 0 to 5, 5 being the worst value.
Time Frame
From Day 0 to Day 3
Secondary Outcome Measure Information:
Title
Change of nasal obstruction between Day 0 and Day 3
Description
Proportion of patients with a change in Peak Inspiratory Nasal Flow value of at least 30 L/min between Day 0 (before use of the spray) and Day 3 (after use of the spray) (arm A).
[0 - 350 L/min] 350 L/min means a better outcome.
Time Frame
From Day 0 to Day 3
Title
Immediate change of nasale obstruction at D0 on first use (Arm A)
Description
Proportion of patients with a change in Peak Inspiratory Nasal Flow value of at least 30 L/min from pre- to post-spray measurements at Day 0 (arm A).
[ 0 - 350 L/min] 350 L/min means a better outcome.
Time Frame
At Day 0
Title
Subjective feeling of reduced nasal obstruction on each day of use (arms A+B).
Description
Proportion of patients with a reduction in the symptom "nasal obstruction" of at least 1pt, on SNOT22 (Sino-Nasal Outcome Test 22), and on each day of use (from Day 0 to Day 6) (arms A+B).
This item is scaled from 0 to 5, 5 being the worst value.
Time Frame
From Day 0 to Day 6
Title
Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B).
Description
Proportion of patients who experienced nasal cavity cleansing (feeling of freshness), on Patient Questionnaire, and on each day of use (from Day 0 to Day 6) (arms A+B).
Time Frame
From Day 0 to Day 6
Title
Subjective feeling of nasal secretion thinning on each day of use (arms A+B).
Description
Proportion of patients with a change in the symptom "thick nasal discharge" of at least 1pt, on SNOT22, and on each day of use (Day 0 to Day 6) (arms A+B).
This item is scaled from 0 to 5, 5 being the worst value.
Time Frame
From Day 0 to Day 6
Title
Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use (arms A+B).
Description
Proportion of patients who experienced relief of nasal (mucosal) irritation, on each day of use (Day 0 to Day 6) (arms A+B).
Time Frame
From Day 0 to Day 6
Title
Subjective feeling of relief of nasal itching on each day of use (arms A+B).
Description
Proportion of patients who experienced relief of nasal itching, on Patient Questionnaire, and on each day of use (Day 0 to Day 6) (arms A+B).
Time Frame
From Day 0 to Day 6
Title
Speed of action at which the patient feels (subjectively) a decrease in nasal obstruction at D0 and D3 (arms A+B).
Description
Proportion of patients with a change in immediate nasal obstruction after use of the spray, on Patient Questionnaire, at Day 0 and Day 3 (arms A+B).
Time Frame
At Day 0 and Day 3
Title
Speed of action at which the patient feels (subjectively) a purification of his nasal cavities (sensation of freshness) at D0 and D3 (arms A+B).
Description
Proportion of patients who experienced immediate nasal cleansing (feeling of freshness) after use of the spray at Day 0 and Day 3 (arms A+B).
Time Frame
At Day 0 and Day 3
Title
Improvement in the patient's quality of life after 7 days of use (arms A+B).
Description
Proportion of patients who experienced an improvement in quality of life, defined as an increase of at least 1pt on a scale of 0-10 between Day 0 and Day 6 (A+B arm).
10 mean a better value.
Time Frame
From Day 0 to Day 6
Title
Patient satisfaction with the medical device after 7 days of use (arm A+B).
Description
Proportion of patients satisfied with the medical device, on a 4-point scale, at Day 6 (arm A+B).
The better value is "very satisfied" and the worst value is "very unsatisfied".
Time Frame
At Day 6
Title
Facility of use of the medical device after 7 days of use (arm A+B)
Description
Proportion of patients who would recommend the medical device at Day 6 (arms A+B).
Time Frame
At Day 6
Title
Evolution of the overall severity of symptoms (arm A+B).
Description
Mean SNOT22 score on each day. Comparison of SNOT22 score at Day 3 versus Day 0 baseline (arms A+B).
[ 0 to 220 ] 0 is the better value.
Time Frame
At Day 0 and Day 3
Title
All adverse events reported by patients using the pocket valve spray after 7 days of use (arm A+B).
Description
All adverse events reported by the patient during the study (arm A+B).
Time Frame
From Day 0 to Day 7
Title
Sensations of tingling and transient irritation (arms A+B).
Description
Proportion of patients with at least 1 adverse event between 1st and last use of the medical device among the following adverse events (arms A+B):
Tingling sensations
Sensations of transient irritation
Time Frame
From Day 0 to Day 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Patient ≥ 12 years.
2. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.
3. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient who has given assent and whose legal guardians have given written consent prior to any study-specific procedure.
4. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.
5. Patient affiliated to a social security scheme.
Exclusion Criteria:
1. Pregnant and/or breastfeeding woman
2. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray.
3. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and/or respiratory insufficiency.
4. Patients with chronic nasal obstruction.
5. Patients on local and systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics and local antiseptics.
6. Concomitant use of other nasal sprays, essential oils for local nasal use, nasal creams or gels.
7. Patients under guardianship, curatorship or safeguard of justice.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carine BRUNEL
Phone
+33 (0)1 45 39 50 21
Email
cbrunel@labogilbert.fr
Facility Information:
Facility Name
Cabinet Médical Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal MABIRE, Dr
Facility Name
Cabinet Médical Gainneville
City
Gainneville
ZIP/Postal Code
76700
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline MENGUY-BROCHET, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction
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