Assessment of a decongestant seawater spray with essential oils for nasal obstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to evaluate the safety and performance of a decongestant seawater spray enriched with essential oils in patients suffering from acute rhinitis associated with nasal obstruction. Over an 8-day period, participants will use the spray, and their peak nasal flow will be measured to assess the effectiveness of the treatment. The study includes patients aged 12 and older who experience nasal obstruction due to various conditions, including infections and allergies. The results will help determine the potential benefits of this novel treatment approach.

Why it matters

Who can join: the full rules

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 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.

Where it's running

• Cabinet Médical
  Blainville-sur-Orne, France Recruiting
• Cabinet Médical Caen
  Caen, France Recruiting
• MSP du Haut Anjou
  Châteauneuf-sur-Sarthe, France Recruiting
• Cabinet Médical Gainneville
  Gainneville, France Withdrawn
• Alyatec
  Strasbourg, France Completed

Study contacts

• Study coordinator: Carine BRUNEL
• Email: cbrunel@labogilbert.fr
• Phone: +33 (0)1 45 39 50 21

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.