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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief: a Prospective, Randomized, Double-blind, Placebo-controlled, Multicentre Clinical Study

Conditions
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Sore Throat

Intervention / Treatment
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* Device: Angiflash
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angiflash<br> | Device: Angiflash<br>* throat spray (20 ml) containing hypertonic seawater, vegetable glycerin, natural mint, acacia honey, propolis extract, essential oils of thyme linalool, ravintsara and wintergreen, natural lemon flavor.<br>* Other names: Seawater based throat spray;|
| Placebo Comparator: Placebo<br> | Device: Placebo<br>* water based throat spray matching Angiflash for posology, dispensed volume, shape and size.<br>* Other names: Placebo throat spray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sore Throat Relief | Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS) | Over the first three days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sore Throat Individual Symptoms Relief | 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 | Day 1, 2, 3, 4, 5, 5, 7 to 8. | 
| Sore Throat Pain Intensity | Change from baseline of the Sore Throat Pain Intensity using a Visual Analog Scale (VAS) (STPIS) | Day 1, 2, 3, 4, 5, 5, 7 to 8. | 
| Difficulty Swallowing | Change from baseline of the difficulty of swallowing using a VAS (DSS) | Day 1, 2, 3, 4, 5, 5, 7 to 8. | 
| Swollen Throat | Change from baseline of the swollen throat using a VAS (SwoTS) | Day 1, 2, 3, 4, 5, 5, 7 to 8. | 
| Overall efficacy assessed by the physician | Overall efficacy assessed by the physician using a 5-point descriptive scale | Day 8 | 
| Compliance: assessment of the number of use per day and the number of spray per use | Assessment of the patient usage: frequency per day and number of spray per use | Day 1, 2, 3, 4, 5, 5, 7 to 8. | 
| Product Satisfaction | Assessment of the overall satisfaction using a 5-point descriptive scale | Day 8 | 
| Incidence of adverse events occuring during the study | Number of adverse events and serious events occuring during the study and evaluation of the severity and causality. | Day 1, 2, 3, 4, 5, 5, 7 to 8. |