Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification (DEFI)

YSLab

Status: Completed

Conditions: Rhinitis

Treatments: Other: Sea water solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04230993

2019-A01705-52

Details and patient eligibility

About

The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.

Full description

The main endpoint is a symptom score derived from the Jackson scale: sum of 2 items relating to runny nose and nasal congestion (stuffy nose), with ratings of 0 to 3 for each (0: absent ; 1: mild; 2: moderate; 3: severe).

Enrollment: 210 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Person with an upper respiratory condition (cold, rhinitis, nasopharyngitis ...) with symptoms of nasal congestion and intense runny nose moderate to severe (Jackson derived score ≥ 4)
• Ability of the patient (for adults) or their legal representative (for children) to follow the guidelines of the medical device
• have given their written informed consent

Exclusion criteria

• Patient with no cold symptoms, including no nasal congestion (chronic dry rhinitis...)
• Patient under treatment with cortisone derivative, mucolytic, or medication containing pseudoephedrine or related product acting on nasal congestion or having used such a product in the 3 days before inclusion
• Patient who used a nasal wash product in the 3 days before inclusion
• Patient allergic to seafood, or to any of the components of the products under study
• Vulnerable patient whose inclusion is not justified by the research objectives: woman pregnant, parturient, psychiatric patient, or adult subject to legal protection
• Patient participating or having participated in any other clinical study in the 30 days before the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

210 participants in 3 patient groups

Ocean Bio Actif-Fluid+

Experimental group

Description:

Moderate hypertonic seawater solution (15 g / L NaCl) with polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.

Treatment:

Other: Sea water solution

Ocean Bio Active-Stuffy nose

Experimental group

Description:

Moderate hypertonic seawater solution (15 g / L NaCl) without polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.

Treatment:

Other: Sea water solution

Ocean Bio Active-Hygiene of the nose

Active Comparator group

Description:

Isotonic seawater solution (9 g / L NaCl). The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.

Treatment:

Other: Sea water solution