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Tests treatment safety and results for Acute Rhinitis
Official 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: "DEVALPO"
ClinicalTrials.gov ID: NCT05494346
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 1\. Patient ≥ 12 years.
- 2\. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or...
- 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...
- 4\. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.
- 5\. Patient affiliated to a social security scheme.
You likely can't join if
- 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 uncontrolled asthma (GINA score greater than or equal to 4)
- 5\. Patients undergoing allergy desensitization
- 6\. Patients suffering from chronic nasal obstruction due to a deformation of the nasal wall or nasal polyps. creams or gels.
See the full eligibility 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...
- 4\. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.
- 5\. Patient affiliated to a social security scheme.
- 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 uncontrolled asthma (GINA score greater than or equal to 4)
- 5\. Patients undergoing allergy desensitization
- 6\. Patients suffering from chronic nasal obstruction due to a deformation of the nasal wall or nasal polyps. creams or gels.
- 7\. Patients taking local and systemic vasoconstrictors, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics.
- 8\. Concomitant use of other nasal sprays, essential oils for local nasal use, creams, or gels for the nose.
- 9\. Patients under guardianship, conservatorship, or legal protection.
The study team makes the final eligibility decision.
Where it's taking place
- Blainville-sur-Orne, France
- Caen, France
- Châteauneuf-sur-Sarthe, France
- Gainneville, France
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blainville-sur-Orne, France; Caen, France; Châteauneuf-sur-Sarthe, France; Gainneville, France; Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.