BАbykids Spray In Common Cold (BASICC)

Lallemand

Status: Completed

Conditions: Rhinitis Viral; Common Cold

Treatments: Device: Healsea Babykids; Device: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05819203

LPH-2202

Details and patient eligibility

About

The purpose of this post market clinical investigation is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo in children above 2 years.

Full description

Healsea® Babykids is an isotonic saline solution based nasal spray supplemented with a natural Symbiofilm® extract (0.04%) isolated from marine bacteria. Symbiofilm® has in vitro antibiofilm activity and protects in vitro human nasal epithelial cells viability after Rhinovirus, Adenovirus, coronavirus OC43 and flu infection.

Healsea® Babykids is a nasal spray indicated in children above 2 years to clean and moisten the nose during colds and rhinitis.

The common cold is an acute viral infection of the upper respiratory tract, involving, to variable degrees, sneezing, nasal congestion and discharge (rhinorrhea), sore throat, cough, low-grade fever, headache, and malaise. Acute viral rhinitis is generally self-limiting. In children where the illness is not self-limiting and extends beyond 7-10 days, many agree that a bacterial infection is likely. Bacterial over infections and progression to a chronic state are favoured by the formation of biofilms, which facilitate bacterial growth and persistence as well as reducing antibiotic efficacy.

The aim of this study is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo.

The study comprises 2 parts:

• Part 1 (Day 1-Day 11): treatment of the acute phase

• with Healsea® Babykids, 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes of Healsea® Babykids) up to 10 days (20 intakes of the investigational device).

or • with isotonic nasal spray (Placebo), 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes of Placebo) up to 10 days (20 intakes of the investigational device).

• Part 2 (up to Day 15/Day 18): follow-up phase.

The study comprises two visits:

• Visit 1 (V1) at Day 1
• End of study visit (Visit 2, V2) between Day 15 and Day 18

Enrollment: 200 patients

Sex: All

Ages: 25 months to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Male/Female subjects >2 and ≤6-year-old
• 2. Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
• 3. Patient presenting with fever ≥ 37.5 °C at screening
• 4. Subjects with nasal congestion (blocked / stuffy nose) rated at least as moderate on the Acute Rhinitis Symptoms Severity Questionnaire, based on evaluation by the investigator
• 5. Subjects showing at least moderate grade for at least one of the following additional signs of acute rhinitis: runny nose, nasal crust (dry mucus), sneezing and cough
• 6. Written consent obtained from parent/legal guardians

Exclusion criteria

• 1. Known hypersensitivity/allergy to any component of the test device
• 2. Medical history that is considered by the investigator as a reason for non-inclusion,
• 3. Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps
• 4. History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
• 5. Antibiotic intake within 2 weeks before screening
• 6. Systemic corticosteroids within 4 weeks before screening
• 7. Chronic decongestant use
• 8. Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence ARSSQ score at screening (NSAID, nasal decongestants, cough medicines)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Healsea Babykids

Experimental group

Description:

Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).

Treatment:

Device: Healsea Babykids

Placebo

Placebo Comparator group

Description:

The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).

Treatment:

Device: Placebo