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The purpose of this post-market clinical investigation is to assess in a real-life setting, the effectiveness, usage, tolerance, safety and satisfaction of 4 isotonic and hypertonic seawater-based CE-marked nasal sprays.
The main questions it aims to answer are:
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Inclusion and exclusion 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:
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:
Primary purpose
Allocation
Interventional model
Masking
1,065 participants in 4 patient groups
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Central trial contact
Gaëlle NAELTEN, PharmD / PhD
Data sourced from clinicaltrials.gov
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