Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief (FLASH)

Laboratoire de la Mer

Status: Unknown

Conditions: Sore Throat

Treatments: Device: Placebo; Device: Angiflash

Study type: Interventional

Funder types: Industry

Identifiers

NCT03369132

FLASH-CZ-2017-01

Details and patient eligibility

About

Prospective, randomized, double-blind, placebo-controlled, multicentre clinical trial to assess the efficacy and tolerability of natural seawater based throat spray among adult patients with acute sore throat.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Adults (male or female) aged ≥ 18 years old.
• 2. Patients with complaint of sore throat ≤ 72h.
• 3. Sore throat exclusively due to upper respiratory tract infection (tonsillitis, pharyngitis, rhinopharyngitis).
• 4. Clinical confirmation by the physician for the presence of typical signs (spontaneous pain, local inflammation) of acute pharyngitis or tonsillitis.
• 5. Pain intensity scored by patient on the 5-point descriptive pain intensity scale as slight, mild or moderate.
• 6. Willingness to provide written informed consent prior to perform of any study related procedure.
• 7. Subjects agreeing to follow the study requirements during the whole study period (including forbidden medication and food supplements).
• 8. Subjects agreeing not to modify their lifestyle habits during the whole study period (diet, physical activity).
• 9. Subject affiliated to social security.
• 10. Subject able to understand verbal and written local language and in capacity to fill-in patient diary by himself/herself.

Exclusion criteria

• 1. Previous history of allergy or known intolerance to one of the following formulation ingredients: seawater, vegetable glycerin, mint, lemon, acacia honey, propolis, essential oils.
• 2. Active Smokers.
• 3. Fever > 38°C at randomization.
• 4. Past or current throat phlegmon.
• 5. Past or current seasonal allergy.
• 6. Past or current asthma.
• 7. Past or current chronic rhinosinusitis.
• 8. Past or current chronic obstructive pulmonary disease (COPD).
• 9. Past or current ENT (Ear, Nose and Throat) cancer.
• 10. Acute rhinosinusitis.
• 11. Controlled or uncontrolled diabetes.
• 12. Gastroesophageal reflux disease (GERD).
• 13. Known immunodeficiency.
• 14. Any painful condition that may distract attention from sore throat pain (ex: mouth ulcers etc.) or that requires analgesic usage.
• 15. Any disease that may interfere with the study aim from investigator's opinion.
• 16. Evidence of mouth breathing or severe coughing.
• 17. Patient with severe pain intensity on 5-point descriptive pain intensity scale.

• 18. Subjects taking:

  • chronic treatment for throat or other ENT pathology,
  • current antibiotherapy or stopped less than 2 weeks before inclusion,
  • chronic treatment (>3 months) with local or systemic corticotherapy, or immunotherapy,
  • local or systemic antihistaminic.

• 19. Subjects refusing to stop at entry into the study:

  • throat spray, lozenge, pastille,
  • local throat or systemic analgesic,
  • medicated confectionary,
  • nasal wash and spray,
  • nasal corticosteroid or antihistaminic nasal spray,
  • medication to gargle,
  • honey, propolis, or any sore throat home remedies.
• 20. Known liver disease or hypersensitivity to paracetamol.
• 21. Pregnant, breastfeeding or seeking pregnancy women.
• 22. Positive result from rapid strep throat test.
• 23. Subjects already included once in this study.
• 24. Subjects participating in another clinical trial or in the exclusion period to another study.
• 25. Subjects having a member of his/her home who is currently participating to this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups, including a placebo group

Angiflash

Experimental group

Treatment:

Device: Angiflash

Placebo

Placebo Comparator group

Treatment:

Device: Placebo