- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05494346
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction (DEVALPO)
Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carine BRUNEL
- Phone Number: +33 (0)1 45 39 50 21
- Email: cbrunel@labogilbert.fr
Study Locations
-
-
-
Caen, France, 14000
- Recruiting
- Cabinet Médical Caen
-
Contact:
- Pascal MABIRE, Dr
-
Gainneville, France, 76700
- Not yet recruiting
- Cabinet Médical Gainneville
-
Contact:
- Céline MENGUY-BROCHET, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm A: Patients with peak nasal flow performed
This arm is made up of major patients.
Nasal flow point measurements will be performed at D0 and D3.
|
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).
|
No Intervention: Arm B: No peak nasal flow
This arm is made up of minor patients.
Unlike arm A, nasal flow measurements will not be performed at D0 and D3.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance of the Gilbert Laboratories pocket valve spray.
Time Frame: From Day 0 to Day 3
|
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. |
From Day 0 to Day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of nasal obstruction between Day 0 and Day 3
Time Frame: From Day 0 to 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. |
From Day 0 to Day 3
|
Immediate change of nasale obstruction at D0 on first use (Arm A)
Time Frame: At Day 0
|
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. |
At Day 0
|
Subjective feeling of reduced nasal obstruction on each day of use (arms A+B).
Time Frame: From Day 0 to Day 6
|
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. |
From Day 0 to Day 6
|
Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B).
Time Frame: From Day 0 to Day 6
|
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).
|
From Day 0 to Day 6
|
Subjective feeling of nasal secretion thinning on each day of use (arms A+B).
Time Frame: From Day 0 to Day 6
|
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. |
From Day 0 to Day 6
|
Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use (arms A+B).
Time Frame: From Day 0 to Day 6
|
Proportion of patients who experienced relief of nasal (mucosal) irritation, on each day of use (Day 0 to Day 6) (arms A+B).
|
From Day 0 to Day 6
|
Subjective feeling of relief of nasal itching on each day of use (arms A+B).
Time Frame: From Day 0 to Day 6
|
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).
|
From Day 0 to Day 6
|
Speed of action at which the patient feels (subjectively) a decrease in nasal obstruction at D0 and D3 (arms A+B).
Time Frame: At Day 0 and Day 3
|
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).
|
At Day 0 and Day 3
|
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).
Time Frame: At Day 0 and Day 3
|
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).
|
At Day 0 and Day 3
|
Improvement in the patient's quality of life after 7 days of use (arms A+B).
Time Frame: From Day 0 to Day 6
|
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. |
From Day 0 to Day 6
|
Patient satisfaction with the medical device after 7 days of use (arm A+B).
Time Frame: At Day 6
|
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". |
At Day 6
|
Facility of use of the medical device after 7 days of use (arm A+B)
Time Frame: At Day 6
|
Proportion of patients who would recommend the medical device at Day 6 (arms A+B).
|
At Day 6
|
Evolution of the overall severity of symptoms (arm A+B).
Time Frame: At Day 0 and Day 3
|
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. |
At Day 0 and Day 3
|
All adverse events reported by patients using the pocket valve spray after 7 days of use (arm A+B).
Time Frame: From Day 0 to Day 7
|
All adverse events reported by the patient during the study (arm A+B).
|
From Day 0 to Day 7
|
Sensations of tingling and transient irritation (arms A+B).
Time Frame: From Day 0 to Day 6
|
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):
|
From Day 0 to Day 6
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Respiration Disorders
- Hypersensitivity, Immediate
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Picornaviridae Infections
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Respiratory Insufficiency
- Pharyngitis
- Airway Obstruction
- Rhinitis
- Rhinitis, Allergic
- Common Cold
- Nasal Obstruction
- Nasopharyngitis
Other Study ID Numbers
- DEVALPO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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