Search / Trial NCT06613906

Prevention with Healsea in Adults Against Respiratory Infection Study

Launched by LALLEMAND PHARMA AG · Sep 23, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Saline Nasal Spray Upper Respiratory Tract Infection Prevention

ClinConnect Summary

The "Prevention with Healsea in Adults Against Respiratory Infection Study" is looking into whether a nasal spray called Healsea® Children can help prevent common respiratory infections, like colds and the flu, in healthy adults. This nasal spray is made from seawater and contains a natural ingredient that forms a protective barrier in the nose, which could stop viruses from getting in. The study will involve 198 adults, who will be divided into two groups: one will use the Healsea® Children spray regularly for 28 days, while the other group will not use the spray at all. Participants will keep track of any nasal symptoms or infections they experience during the study.

To be eligible for this study, participants need to be healthy adults aged 18 or older, with no recent respiratory infections. They must have a smartphone and internet access to help with study tasks, including reporting symptoms. Throughout the study, participants will attend two visits and have three phone check-ins, and they will also fill out an electronic diary to record their health. This study is a great opportunity for those who meet the criteria and are interested in helping researchers understand if this nasal spray can effectively reduce the risk of respiratory infections.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Subjects will be enrolled if they meet all the following criteria:
  • 1. Healthy Male/Female subjects ≥18 years
  • 2. No respiratory tract infection within 15 days before trial entry and at trial entry
  • 3. Willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the information consent form
  • 4. Availability of a smartphone throughout the study and an internet connection.
  • Exclusion Criteria:
  • Subjects will not be enrolled if one of the following criteria is present:
  • 1. Known hypersensitivity/allergy to any component of the test device
  • 2. Subject with COPD, severe asthma, perennial allergy, immunodeficiency or cystic fibrosis
  • 3. Body temperature ≥ 37.8°C
  • 4. Medical history or any current disease that is considered by the investigator as a reason for non-inclusion
  • 5. Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps
  • 6. Antibiotic (systemic or per nasal route) or antivirals (systemic) intake within 2 weeks before screening
  • 7. Systemic or local corticosteroids (nasal route or inhalation) within 4 weeks before screening
  • 8. Antihistamines intake for allergy when treatment was started from less than 4 weeks before screening
  • 9. Vaccination against flu or COVID-19 within 6 months before screening
  • 10. Chronic decongestant use within 2 weeks before screening
  • 11. Bacterial lysates, or immunostimulants (food supplements excluded) used for prevention of infection within the 6 months before the screening
  • 12. Prebiotics, probiotics used for prevention of infection within 6 months before the screening
  • 13. Pregnant/Lactating female or of childbearing potential without hormonal contraception or intrauterine device or double barrier method.

About Lallemand Pharma Ag

Lallemand Pharma AG is a leading pharmaceutical company specializing in the development and commercialization of innovative healthcare solutions. With a strong emphasis on research and development, Lallemand Pharma focuses on advancing therapies that enhance patient outcomes across various therapeutic areas. The company is committed to maintaining high standards of quality and regulatory compliance, ensuring that its clinical trials are conducted with integrity and scientific rigor. Lallemand Pharma AG collaborates with healthcare professionals and stakeholders to deliver effective treatments that address unmet medical needs, ultimately improving the quality of life for patients worldwide.

Locations

Sofia, , Bulgaria

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0