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 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT07262450
Eligibility Criteria:
Inclusion criteria:
* Subject's age and medical condition in compliance with the intended use and population
* Subjects who, from the investigator's judgement, should benefit from nasal wash in accordance with routine medical practice
* Subjects with at least two nasal symptoms of intensity ≥ 3 (6 modalities intensity SNOT-22 rating-scale) among the following:
* Nasal blockage/nasal congestion/ stuffy nose;
* Runny nose;
* Need to blow/clear the nose;
* Sneezing;
* Thick nasal discharge/secretions;
* Decreased sense of smell /taste (replaced by "noisy breathing/mouth breathing" for infants)
* Subjects with impaired nasal breathing (score ≥ 3, 6-modalities intensity rating-scale), induced by the presence of nasal symptoms
* For acute indications (only): subjects with symptoms started not later than 72 hours prior to enrolment (Day 0).
* For allergic rhinitis indication: perennial allergic rhinitis with and without seasonal allergic rhinitis
* For post-surgery indication: septoplasty and rhinoseptoplasty.
* Subject/parent willing to perform nasal wash following advices received from HCPs.
* Subjects (or parents for babies and children) agreeing to follow the study requirements during the whole study period (up to 3 months).
* Subject (or parent for baby and children) able to understand verbal and written local language and in capacity to fill-in questionnaire by himself.
* Subject having daily access to internet to answer online questionnaire.
* Subject or Parent/legal guardian of the subject has given freely and expressly her/his informed consent.
* Subject affiliated to the health social security system or beneficiary of an equivalent system
Non-inclusion criteria:
* Subject with contraindications according to each IFU.
* Hypersensitivity or known allergy to any component of the investigational products.
* Subject taking part in another clinical study or being in the exclusion period of another clinical study.
* Subject already using nasal wash to manage his nasal symptoms.
* Subject already included once in the study.
* Subject with a member of his household already included in the study if still in the follow-up phase.
* Subject deprived of liberty by administrative or judicial decision or under legal guardianship.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Days
Study:
NCT07262450
Study Brief:
Protocol Section:
NCT07262450