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

Sore Throat Clinical Trial

— FLASH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03369132
• Other study ID #: FLASH-CZ-2017-01
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2017
• Last updated: December 21, 2017
• Start date: November 6, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: December 2017
• Source: Laboratoire de la Mer
• Contact: Gaelle Naelten, Pharm.D,Ph.D
• Phone: +33 (0)299 215 387
• Email: gaelle.naelten[@]perrigo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: September 30, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pharyngitis
• Sore Throat

Intervention

Device:
• Angiflash
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.
• Placebo
water based throat spray matching Angiflash for posology, dispensed volume, shape and size.

Locations

Country	Name	City	State
Czechia	MUDr. Lenka Dybova	Brno
Czechia	MUDr. Libor Hemzsky	Choltice
Czechia	NEFROMED s.r.o.	Dejvice
Czechia	MEDIGATE care s.r.o	Hradec Králové
Czechia	MUDr. Jana Dvorakova s.r.o.	Hradec Králové
Czechia	MUDr. Petra Hoskova	Hradec Králové
Czechia	MUDr. Danuse Mikeschova	Karlovy Vary
Czechia	Azita s.r.o.	Malšice
Czechia	Fortmedica s.r.o.	Praha 4
Czechia	GM ordinace s.r.o	Praha 4
Czechia	MUDr Sylva Kohoutova	Praha 6
Czechia	MUDr. Lenka Fejfarova	Praha 6
Czechia	Ordinace Optima s.r.o	Praha 6
Czechia	Saniga s.r.o.	Sokolov
Czechia	MUDr. Jan Bartusek	Teplice
Czechia	A-MEDICOS s.r.o.	Zlín

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire de la Mer

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sore Throat Relief	Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)	Over the first three days
Secondary	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.
Secondary	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.
Secondary	Difficulty Swallowing	Change from baseline of the difficulty of swallowing using a VAS (DSS)	Day 1, 2, 3, 4, 5, 5, 7 to 8.
Secondary	Swollen Throat	Change from baseline of the swollen throat using a VAS (SwoTS)	Day 1, 2, 3, 4, 5, 5, 7 to 8.
Secondary	Overall efficacy assessed by the physician	Overall efficacy assessed by the physician using a 5-point descriptive scale	Day 8
Secondary	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.
Secondary	Product Satisfaction	Assessment of the overall satisfaction using a 5-point descriptive scale	Day 8
Secondary	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.