BАbykids Spray In Common Cold (BASICC)

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

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.

Study Overview

• Status: Completed
• Conditions: Common Cold; Rhinitis Viral
• Intervention / Treatment: Device: Healsea Babykids; Device: Placebo

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 Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria
    • Medical Center
  • Sofia, Bulgaria
    • Medical Center
  • Vratsa, Bulgaria
    • Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The area under the curve (AUC) of the global score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) during first 10 days of symptoms	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.	From Day 1 to Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of each cold symptom (questions 2 to 7 of the ARSSQ) in both groups	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.	Through study completion, up to Day 18
Duration of quality-of-life impairment (questions 8 to 10 of the ARSSQ).	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.	Through study completion, up to Day 18
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)	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.	Through study completion, up to Day 18
Safety: adverse events and incidents throughout the study	Assessment of adverse event related to acute rhinitis and incidents throughout the study in both groups.	Through study completion, up to Day 18

Collaborators and Investigators

• Sponsor: Lallemand Pharma AG
• Investigators: Principal Investigator: Rada MARKOVA, MD, Medical Center, Sofia

Publications and helpful links

General Publications

• Passioti M, Maggina P, Megremis S, Papadopoulos NG. The common cold: potential for future prevention or cure. Curr Allergy Asthma Rep. 2014 Feb;14(2):413. doi: 10.1007/s11882-013-0413-5.
• Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.
• Heikkinen T, Jarvinen A. The common cold. Lancet. 2003 Jan 4;361(9351):51-9. doi: 10.1016/S0140-6736(03)12162-9.
• Principi N, Esposito S. Nasal Irrigation: An Imprecisely Defined Medical Procedure. Int J Environ Res Public Health. 2017 May 11;14(5):516. doi: 10.3390/ijerph14050516.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): May 16, 2023
• Study Completion (Actual): May 16, 2023

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: children; nasal spray; supplemented isotonic saline solution; infectious rhinitis
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Picornaviridae Infections; Nose Diseases; Rhinitis; Common Cold
• Other Study ID Numbers: LPH-2202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No