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)

December 12, 2023 updated by: Laboratoires Gilbert

Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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):

  • Tingling sensations
  • Sensations of transient irritation
From Day 0 to Day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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