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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07383493
Eligibility Criteria:
Inclusion Criteria:
* Acute viral rhinitis or acute rhinosinusitis or viral rhinopharyngitis (sneezing, rhinorrhea, nasal obstruction, cough secondary to posterior rhinorrhea, sore throat) that began less than 72 hours prior to the inclusion visit, in the investigator's judgment,
* Effective contraception for female patients of childbearing age.
* Cooperation and sufficient understanding to comply with the requirements of the trial.
* Acceptance of registration in the SI-RIPH VRB file.
* Having received informed information and agreeing to give written consent.
* Affiliated with the French Social Security system.
Exclusion Criteria:
* Hypersensitivity/history of allergy to any of the product's components,
* Complicated rhinitis, rhinosinusitis, or rhinopharyngitis (acute bacterial sinusitis, acute otitis media, acute bronchitis, or pneumonia) or severe cough that is poorly tolerated,
* Chronic rhinosinusitis,
* Allergic rhinosinusitis,
* Other ongoing treatments for acute rhinitis (local treatment, antitussives, antibiotics, antiretrovirals, corticosteroids, etc.),
* Positive antigen test for influenza A/B or COVID-19 and infection requiring etiological treatment according to the recommendations,
* Bacterial rhinopharyngitis with positive TROD test
* Comorbidities or health conditions deemed incompatible with the trial by the investigator,
* Recent ENT surgery (\<6 months),
* ENT pathology such as nasal septum deviation or other causes of nasal obstruction,
* Pulmonary pathology (COPD, asthma, etc.),
* Immunosuppression (as reported by the patient),
* Pregnant or breastfeeding women,
* Currently participating in another clinical trial, or in the exclusion period, or having received total compensation of more than €6,000 in the 12 months prior to the start of the trial,
* Benefiting from legal protection measures (guardianship, trusteeship, deprivation of liberty, judicial protection).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07383493
Study Brief:
Protocol Section:
NCT07383493