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Tests treatment safety and results for URTI
Official title Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
ClinicalTrials.gov ID: NCT07262450
What this study is testing
- What it's testing
- 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: Efficacy, Safety, Usage, Satisfaction, in real-life usage among infants, children, adults and pregnant or breastfeeding women suffering from acute and chronic sinonasal pathologies.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- Subject's age and medical condition in compliance with the intended use and population
- people who, from the investigator's judgement, should benefit from nasal wash in accordance with routine medical practice
- people 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;
See the full eligibility criteria
- Subject's age and medical condition in compliance with the intended use and population
- people who, from the investigator's judgement, should benefit from nasal wash in accordance with routine medical practice
- people 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)
- people with impaired nasal breathing (score ≥ 3, 6-modalities intensity rating-scale), induced by the presence of nasal symptoms
- For acute indications (only): people 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.
- people (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-
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Bourg-la-Reine, France
- Cabourg, France
- Châteauroux, France
- Châtenay-Malabry, France
- Chevaigné, France
- Clermont-Ferrand, France
- Courrières, France
- Falaise, France
- Heyrieux, France
- La Roche-sur-Yon, France
- Marcq-en-Barœul, France
- Marseille, France
- Metz, France
- Montpellier, France
- Poitiers, France
- Pont-Audemer, France
- Pont-Saint-Martin, France
- Rennes, France
- Roézé-sur-Sarthe, France
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 days and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Bourg-la-Reine, France; Cabourg, France; Châteauroux, France; Châtenay-Malabry, France; Chevaigné, France and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.