Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT06613906
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06613906
Study Brief:
Protocol Section:
NCT06613906