Clinical trial NCT05819203: BАbykids Spray In Common Cold
Official title: Efficacy and Safety of Healsea® Babykids in the Treatment of Acute Infectious Rhinitis Symptoms in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Rhinitis Viral
Keywords: nasal spray
supplemented isotonic saline solution
infectious rhinitis
children
Lead sponsor: Lallemand Pharma AG
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial double blind
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Full Analysis Set (FAS)
timeFrame: From Day 1 to Day 10
measure: The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Per Protocol Set (PP)
timeFrame: From Day 1 to Day 10
Secondary outcomes:
measure: Duration of Each Cold Symptom (Questions 2 to 7 of the ARSSQ) in Both Groups
timeFrame: Through study completion, up to Day 18
measure: Duration of Quality-of-life Impairment (Questions 8 to 10 of the ARSSQ).
timeFrame: Through study completion, up to Day 18
measure: Cumulative Number of Days of Concomitant Treatments Use That May Affect Common Cold Symptoms (Antibiotics, Antipyretics, Systemic or Local Mucolytics, Decongestants, Antitussives, Systemic and Topical Corticosteroids)
timeFrame: Through study completion, up to Day 18
measure: Cumulative Number of Days of Antibiotics Intake
timeFrame: through study completion , up to day 18
measure: Cumulative Number of Days of Antipyretics Intake
timeFrame: through study completion, up to day 18
measure: Cumulative Number of Days of Mucolytics Intake
timeFrame: Through study completion , up to day 18
measure: Cumulative Number of Days of Decongestants Use
timeFrame: through study completion, up to day 18
measure: Cumulative Number of Days of Antitussives Use
timeFrame: through study completion, up to day 18
measure: Cumulative Number of Days of Systemic and Topical Corticosteroids Use
timeFrame: Through study completion, up to day 18
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Medical center
city: Sofia
country: Bulgaria
facility: Medical center
city: Vratsa
country: Bulgaria
facility: Medical center
Study officials:
affiliation: Medical Center, Sofia
name: Rada MARKOVA, MD
role: PRINCIPAL_INVESTIGATOR
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