BASICC: BАbykids Spray In Common Cold

Sponsor

Lallemand Pharma AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05819203

Collaborator

(none)

200

Enrollment

Locations

Arms

3.5

Anticipated Duration (Months)

Patients Per Site

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Common Cold Rhinitis Viral	Device: Healsea Babykids Device: Placebo	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trial double blindRandomized controlled trial double blind

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

The investigational device and the comparator were indistinguishable. The comparator (isotonic nasal spray) used the same technology and the same packaging than Healsea Babykids. A white label with regulatory mentions for clinical investigations was stuck on the vial A white label with regulatory mentions was sticked on a white cardboard box used as secondary packaging. The IFUs (Bulgarian version) was included in the secondary packaging (on one face, Healsea Babykids, on the other face Placebo

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Healsea® Babykids in the Treatment of Acute Infectious Rhinitis Symptoms in Children

Actual Study Start Date :

Feb 13, 2023

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healsea Babykids 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 ).	Device: Healsea Babykids 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Placebo Comparator: Placebo 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 ).	Device: Placebo 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .

Arm

Intervention/Treatment

Experimental: Healsea Babykids

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 ).

Device: Healsea Babykids

7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .

Placebo Comparator: Placebo

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 ).

Device: Placebo

7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .

Outcome Measures

Primary Outcome Measures

The area under the curve (AUC) of the global score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) during first 10 days of symptoms [From Day 1 to Day 10]
ARSSQ is a non-validated customized questionnaire . It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening.

Secondary Outcome Measures

Duration of each cold symptom (questions 2 to 7 of the ARSSQ) in both groups [Through study completion, up to Day 18]
For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days. Duration may be censored at Visit 2.
Duration of quality-of-life impairment (questions 8 to 10 of the ARSSQ). [Through study completion, up to Day 18]
For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days. Duration may be censored at Visit 2.
Frequency and 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) [Through study completion, up to Day 18]
Concomitant treatments use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.
Safety: adverse events and incidents throughout the study [Through study completion, up to Day 18]
Assessment of adverse event related to acute rhinitis and incidents throughout the study in both groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Months to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Male/Female subjects >2 and ≤6-year-old
1. Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
1. Patient presenting with fever ≥ 37.5 °C at screening
1. 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
1. 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
1. Written consent obtained from parent/legal guardians

Exclusion Criteria:

1. Known hypersensitivity/allergy to any component of the test device
1. Medical history that is considered by the investigator as a reason for non-inclusion,
1. Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps
1. History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
1. Antibiotic intake within 2 weeks before screening
1. Systemic corticosteroids within 4 weeks before screening
1. Chronic decongestant use
1. 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)

Contacts and Locations

Locations

	Site	City	Country
1	Medical center	Plovdiv	Bulgaria
2	Medical center	Plovdiv	Bulgaria
3	Medical center	Sofia	Bulgaria
4	Medical center	Sofia	Bulgaria
5	Medical center	Sofia	Bulgaria
6	Medical center	Sofia	Bulgaria
7	Medical center	Sofia	Bulgaria
8	Medical center	Vratsa	Bulgaria