Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief

Not Applicable

• Conditions: Sore Throat
• Interventions: Device: Angiflash; Device: Placebo

• Registration Number: NCT03369132
• Lead Sponsor: Laboratoire de la Mer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-06
• Study First Submitted: 2017-11-16
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-11
• Last Update Submitted: 2017-12-21
• Last Update Posted: 2017-12-22
• Primary Completion: 2018-05-31
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Angiflash	Angiflash	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Sore Throat Relief	Over the first three days	Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)

Secondary Outcome Measures

Name	Time	Method
Product Satisfaction	Day 8	Assessment of the overall satisfaction using a 5-point descriptive scale
Sore Throat Pain Intensity	Day 1, 2, 3, 4, 5, 5, 7 to 8.	Change from baseline of the Sore Throat Pain Intensity using a Visual Analog Scale (VAS) (STPIS)
Difficulty Swallowing	Day 1, 2, 3, 4, 5, 5, 7 to 8.	Change from baseline of the difficulty of swallowing using a VAS (DSS)
Overall efficacy assessed by the physician	Day 8	Overall efficacy assessed by the physician using a 5-point descriptive scale
Incidence of adverse events occuring during the study	Day 1, 2, 3, 4, 5, 5, 7 to 8.	Number of adverse events and serious events occuring during the study and evaluation of the severity and causality.
Sore Throat Individual Symptoms Relief	Day 1, 2, 3, 4, 5, 5, 7 to 8.	Evaluation of relief of sore throat individual symptoms (dry throat, burning/painful sensation, hoarseness/husky voice, painful talk, painful swallowing, irritation, prickly sensation/tingle, scratchy/itchy throat) using a 10-point rating scale
Swollen Throat	Day 1, 2, 3, 4, 5, 5, 7 to 8.	Change from baseline of the swollen throat using a VAS (SwoTS)
Compliance: assessment of the number of use per day and the number of spray per use	Day 1, 2, 3, 4, 5, 5, 7 to 8.	Assessment of the patient usage: frequency per day and number of spray per use

Trial Locations

Locations (16)

MUDr. Libor Hemzsky; 🇨🇿 Choltice, Czechia

MUDr. Lenka Dybova; 🇨🇿 Brno, Czechia

NEFROMED s.r.o.; 🇨🇿 Dejvice, Czechia

MEDIGATE care s.r.o; 🇨🇿 Hradec Králové, Czechia

MUDr. Petra Hoskova; 🇨🇿 Hradec Králové, Czechia

MUDr. Jana Dvorakova s.r.o.; 🇨🇿 Hradec Králové, Czechia

MUDr. Danuse Mikeschova; 🇨🇿 Karlovy Vary, Czechia

GM ordinace s.r.o; 🇨🇿 Praha 4, Czechia

Azita s.r.o.; 🇨🇿 Malšice, Czechia

Fortmedica s.r.o.; 🇨🇿 Praha 4, Czechia

MUDr Sylva Kohoutova; 🇨🇿 Praha 6, Czechia

Ordinace Optima s.r.o; 🇨🇿 Praha 6, Czechia

MUDr. Lenka Fejfarova; 🇨🇿 Praha 6, Czechia

MUDr. Jan Bartusek; 🇨🇿 Teplice, Czechia

Saniga s.r.o.; 🇨🇿 Sokolov, Czechia

A-MEDICOS s.r.o.; 🇨🇿 Zlín, Czechia