Prevention With Healsea in Adults Against Respiratory Infection Study

NCT06613906 | Completed

• 2 other identifiers: LPH-24012833/06/08/2024
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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 not only in children (HEALSPIC study, NCT06582589) but also in adults. 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 adults during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days when compared to adults not taking Healsea® Children. 198 adults will be randomised in the study, 99 in the Healsea® Children group and 99 in the non-treated group. The subjects 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 events other than upper respiratory tracts infections.

Conditions

Healthy Subjects (HS)

Keywords

saline nasal spray; upper respiratory tract infection; prevention

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 the study. 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 (5)

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

  Time Frame: From the randomization up to Day 116

• Number of Upper Respiratory Tract Infections complications

  Time Frame: 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

• Assessment of (serious) adverse events and device deficiences throughout the study

  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 during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days

Untreated arm

NO INTERVENTION

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

Interventions

Healsea Children nasal spray DEVICE

dosage: 1 puff in each nostril twice daily during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be enrolled if they meet all the following criteria:
• Healthy Male/Female subjects ≥18 years
• No respiratory tract infection within 15 days before trial entry and at trial entry
• Willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the information consent form
• Availability of a smartphone throughout the study and an internet connection.

You may not qualify if:

• Subjects will not be enrolled if one of the following criteria is present:
• Known hypersensitivity/allergy to any component of the test device
• Subject with COPD, severe asthma, perennial allergy, immunodeficiency or cystic fibrosis
• Body temperature ≥ 37.8°C
• 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 of childbearing potential without hormonal contraception or intrauterine device or double barrier method.

Sponsors & Collaborators

• Lallemand Pharma AG: lead

Study Sites (1)

Diagnostics and Consultation Center Convex EOOD,

Sofia, 1680, Bulgaria

Location

Related Publications (4)

• 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

• 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

• 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

• Jaume F, Valls-Mateus M, Mullol J. Common Cold and Acute Rhinosinusitis: Up-to-Date Management in 2020. Curr Allergy Asthma Rep. 2020 Jun 3;20(7):28. doi: 10.1007/s11882-020-00917-5.

  PMID: 32495003 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: November 29, 2024
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

BU (1)