Seawater nasal sprays for relief of nasal and sinus symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a post-market, real-life setting, this investigation will follow people using four CE-marked isotonic and hypertonic seawater nasal sprays used according to each device's intended instructions. The study will collect data on symptom change, device usage patterns, tolerance, safety events, and user satisfaction across age groups including infants and pregnant or breastfeeding women with conditions such as URTI, bronchiolitis, COVID-19, allergic rhinitis, and chronic rhinosinusitis. Eligible participants must report at least two moderate nasal symptoms and, for acute presentations, symptom onset within 72 hours; treatments will be applied as in routine practice. Outcomes will rely mainly on patient-reported symptom scores, safety/tolerance reporting, and device usage information.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU Bordeaux
  Bordeaux, France Recruiting
• Pharmacie de la Faïncerie
  Bourg-la-Reine, France Recruiting
• Pharmacie Marine
  Cabourg, France Recruiting
• Pharmacie Daguet
  Châteauroux, France Recruiting
• Pharmacie des verts coteaux
  Châtenay-Malabry, France Recruiting
• Pharmacie Lombard
  Châtenay-Malabry, France Recruiting

Study contacts

• Study coordinator: Gaëlle NAELTEN, PharmD / PhD
• Email: gaelle.naelten@perrigo.com
• Phone: +330633901291

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) in Adults

  This study tests and compares the immune responses and tolerability of the latest COVID-19 vaccines from Novavax and Pfizer/BioNTech in adults at risk for severe COVID-19.

  Recruiting Phase 4 Henry M. Jackson Foundation for the Advancement of Military Medicine · Bethesda, Maryland · NCT07287137

• Mannan-Conjugated Allergoids for House Dust M mite Allergy

  A new treatment named EP-088_MM09 is being tested to see if it can reduce nasal and eye allergy symptoms (and possibly asthma) in people aged 12 to 65 who are allergic to house dust mites, compared with a placebo.

  Recruiting at 2 sites Phase 3 Inmunotek S.L. · Covilha, Castelo Branco District and 15 other locations · NCT07904195

• Mannan-conjugated Allergoids for House Dust Mite Allergy

  A new treatment called EP-088_MM09 is being tested to see if it can reduce allergy symptoms in people with house dust mite–related nasal allergy, with or without mild asthma.

  Recruiting at 4 sites Phase 3 Inmunotek S.L. · Coimbra and 15 other locations · NCT07904052

• Omicron-based COVID-19 vaccine with Matrix-M given as a single dose in older adults and high-risk individuals

  A single-dose Omicron-subvariant vaccine with Matrix-M is tested to see if it is safe and can induce an immune response in adults 65+ and in younger adults with conditions that raise the risk of severe COVID-19, who were previously vaccinated.

  Recruiting at 20 sites Phase 4 Sanofi · Fair Oaks, California and 19 other locations · NCT07861542

• Optimising Antibiotic Use for Paediatric LRTIs in Africa

  This study tests whether using point-of-care CRP tests together with the PREPARE score can safely reduce antibiotic use in infants aged 2–24 months with lower respiratory infections in a Johannesburg hospital.

  Recruiting University of Witwatersrand, South Africa · Johannesburg, Gauteng · NCT07841691

• Secutrelvir for nonhospitalized COVID-19 in teens and adults

  This study tests whether secutrelvir can help nonhospitalized people with COVID-19 see faster symptom relief compared with a placebo.

  Recruiting Phase 3 Shionogi Inc. · Multiple Locations · NCT07746544

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.