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:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT05819203
Eligibility Criteria:
Inclusion Criteria:
* 1\. Male/Female subjects \>2 and ≤6-year-old
* 2\. Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
* 3\. Patient presenting with fever ≥ 37.5 °C at screening
* 4\. Subjects with nasal congestion (blocked / stuffy nose) rated at least as moderate on the Acute Rhinitis Symptoms Severity Questionnaire, based on evaluation by the investigator
* 5\. Subjects showing at least moderate grade for at least one of the following additional signs of acute rhinitis: runny nose, nasal crust (dry mucus), sneezing and cough
* 6\. Written consent obtained from parent/legal guardians
Exclusion Criteria:
* 1\. Known hypersensitivity/allergy to any component of the test device
* 2\. Medical history that is considered by the investigator as a reason for non-inclusion,
* 3\. Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps
* 4\. History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
* 5\. Antibiotic intake within 2 weeks before screening
* 6\. Systemic corticosteroids within 4 weeks before screening
* 7\. Chronic decongestant use
* 8\. Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence ARSSQ score at screening (NSAID, nasal decongestants, cough medicines)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Months
Maximum Age:
6 Years
Study:
NCT05819203
Study Brief:
Protocol Section:
NCT05819203