HEALSea Nasal Spray for Prevention of Infections in Children

NCT06582589 | Completed Phase 2

• 2 other identifiers: LPH-24022819/02.08.2024
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 8

Brief Summary

Healsea® Children is a class IIa medical device. This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm™ extract (0.02%) isolated from marine bacteria. Healsea® Children is indicated in children above 6 years to clean and moisten the nose during colds. Symbiofilm™, which is not a medicinal product is able to protect the nasal mucosa from viruses' entrance by forming a protective barrier on the nasal mucosa. By targeting the nose as entry points for viruses, we hypothesise that Healsea® Children used regularly during the respiratory virus season may prevent upper respiratory tracts infections such as cold or flu with nasal symptoms. The main objective of this premarket clinical investigation is thus to assess the efficacy of Healsea® Children to prevent upper respiratory tract infections with nasal symptoms in healthy children during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days when compared to children not taking Healsea® Children. 138 children will be randomised in the study, 64 in the Healsea® Children group and 64 in the non-treated group. The subjects (or their parents) will be asked to report the upper respiratory tract infections with nasal symptoms and complication they may have during the study to the physician in charge of the study conduct. Two study visits and 3 telephone calls are scheduled. The subjects will also complete an electronic diary to report nasal symptoms and adverse event other than upper respiratory tracts infections.

Conditions

Healthy Subjects

Keywords

Prevention; Nasal spray; upper respiratory tract infection; saline solution

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects without any upper respiratory tract infection (URTI) with nasal symptoms during the study.

  The upper respiratory tracts infections with nasal symptoms (blocked nose, runny nose yellow or green discharge, sneezing ) will be collected for each subject throughout An URTI episode with nasal symptoms is defined as follows: (i) at least 1 of the followings must be present: a blocked nose, runny nose, yellow or green nasal discharge, sneezing; (ii) the symptomatic episode must last for at least 3 days.

  From the randomization up to Day 116

Secondary Outcomes (6)

• Time to first Upper Respiratory Tract Infection with nasal symptoms during the study

  From the randomization up to Day 116

• Number of Upper Respiratory Tract Infections with nasal symptoms during the study

  From the randomization up to Day 116

• Number of Upper Respiratory Tract Infections complications

  From the randomization up to Day 116

• Number of days of use of concomitant treatments that may affect Upper Respiratory Tract Infections symptoms and associated complications

  From the randomization up to Day 116

• Number of school days lost due to Upper Respiratory Tract Infections and complications

  From the randomization up to Day 116

Study Arms (2)

Healsea Children treated group

EXPERIMENTAL

Subjects of this arm will be treated with Healsea Children nasal spray (1 puff in each nostril twice daily) during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days

Device: Healsea Children

untreated group

NO INTERVENTION

Subjects of this arm will not receive any treatment for the prevention of respiratory tract infection.

Interventions

Healsea Children DEVICE

Subjects will use Healsea Children 1 puff in each nostril twice daily upon awakening and at bedtime, during three 28-day treatment periods interspersed by a 10-day wash-out

Healsea Children treated group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male/Female subjects ≥6 and \<18-year-old
• No respiratory tract infection within 15 days before trial entry and at trial entry
• Written consent obtained from parent/legal guardians
• Written assent obtained from patient
• Availability of a smartphone throughout the study and an internet connection.-

You may not qualify if:

• Known hypersensitivity/allergy to any component of the test device,
• Subject with severe asthma, perennial allergy, cystic fibrosis, immunodeficiency or ciliary dyskinesis,
• Body temperature ≥ 37.5°
• Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps,
• Antibiotic (systemic or per nasal route) or antivirals (systemic) intake within 2 weeks before screening,
• Systemic or local corticosteroids (nasal route or inhalation) within 4 weeks before screening,
• Antihistamines intake for allergy when treatment was started from less than 4 weeks before screening,
• Vaccination against flu or COVID-19 within 6 months before screening,
• Chronic decongestant use within 2 weeks before screening,
• Bacterial lysates or immunostimulants (food supplements excluded) used for prevention of infection within the 6 months before the screening,
• Prebiotics, probiotics used for prevention of infection within 6 months before the screening,
• Pregnant/Lactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods.

Sponsors & Collaborators

• Lallemand Pharma AG: lead

Study Sites (8)

Multiprofile Hospital for Active Treatment Sveti Ivan Rilski -2003 OOD

Dupnitsa, 2600, Bulgaria

Location

Medical Center Plovdimed Ltd

Plovdiv, 4023, Bulgaria

Location

Medical Center Iskar EOOD

Sofia, 1000, Bulgaria

Location

Medical Center Polymed AD

Sofia, 1303, Bulgaria

Location

Medical Center First Pediatric

Sofia, 1404, Bulgaria

Location

Multiprofile Hospital for active treatment

Sofia, 1618, Bulgaria

Location

Diagnostics and Consultation Center Convex EOOD

Sofia, 1680, Bulgaria

Location

Ambulatory for individual Practice for specialized outpatient medical care for children's diseases and pediatric pneumology ans phtysiatry

Vratsa, 3001, Bulgaria

Location

Related Publications (5)

• Tano L, Tano K. A daily nasal spray with saline prevents symptoms of rhinitis. Acta Otolaryngol. 2004 Nov;124(9):1059-62. doi: 10.1080/00016480410017657.

  PMID: 15513550 BACKGROUND

• Cabaillot A, Vorilhon P, Roca M, Boussageon R, Eschalier B, Pereirad B. Saline nasal irrigation for acute upper respiratory tract infections in infants and children: A systematic review and meta-analysis. Paediatr Respir Rev. 2020 Nov;36:151-158. doi: 10.1016/j.prrv.2019.11.003. Epub 2020 Feb 21.

  PMID: 32312677 BACKGROUND

• Stanfel D, Kalogjera L, Ryazantsev SV, Hlaca K, Radtsig EY, Teimuraz R, Hrabac P. The Role of Seawater and Saline Solutions in Treatment of Upper Respiratory Conditions. Mar Drugs. 2022 May 17;20(5):330. doi: 10.3390/md20050330.

  PMID: 35621981 BACKGROUND

• Slapak I, Skoupa J, Strnad P, Hornik P. Efficacy of isotonic nasal wash (seawater) in the treatment and prevention of rhinitis in children. Arch Otolaryngol Head Neck Surg. 2008 Jan;134(1):67-74. doi: 10.1001/archoto.2007.19.

  PMID: 18209140 BACKGROUND

• Williamson S, Dennison L, Greenwell K, Denison-Day J, Mowbray F, Richards-Hall S, Smith D, Bradbury K, Ainsworth B, Little P, Geraghty AWA, Yardley L. Using nasal sprays to prevent respiratory tract infections: a qualitative study of online consumer reviews and primary care patient interviews. BMJ Open. 2022 Jun 30;12(6):e059661. doi: 10.1136/bmjopen-2021-059661.

  PMID: 35772824 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective randomized open label pre-market clinical investigation

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: November 25, 2024
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

BU (8)