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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sore Throat
• Intervention / Treatment: Device: Angiflash; Device: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaelle Naelten, Pharm.D,Ph.D; Phone Number: +33 (0)299 215 387; Email: gaelle.naelten@perrigo.com
• Study Contact Backup: Name: Olivia Gavard, Ph.D.; Phone Number: +33 (0)256 521 017; Email: olivia.gavard@perrigo.com

Study Locations

• Czechia
  • Brno, Czechia, 602 00
    • Recruiting
    • MUDr. Lenka Dybova
    • Contact: Lenka Dybova, M. D.
  • Choltice, Czechia, 533 61
    • Recruiting
    • MUDr. Libor Hemzsky
    • Contact: Libor Hemzsky, M. D.
  • Dejvice, Czechia, 160 00
    • Recruiting
    • Nefromed s.r.o.
    • Contact: Krisitina Sadilkova, M. D.
  • Hradec Králové, Czechia, 500 09
    • Recruiting
    • MEDIGATE care s.r.o
    • Contact: Ivana Skardova, M. D.
    • Sub-Investigator: Jan Skarda, M. D.
  • Hradec Králové, Czechia, 500 09
    • Recruiting
    • MUDr. Petra Hoskova
    • Contact: Petra Hoskova, M. D.
  • Hradec Králové, Czechia, 500 11
    • Recruiting
    • MUDr. Jana Dvorakova s.r.o.
    • Contact: Jana Dvorakova, M. D.
  • Karlovy Vary, Czechia, 360 17
    • Recruiting
    • MUDr. Danuse Mikeschova
    • Contact: David Macharacek, M. D.
  • Malšice, Czechia, 108 00
    • Recruiting
    • Azita s.r.o.
    • Contact: Azita Gebauerova, M. D.
  • Praha 4, Czechia, 143 00
    • Recruiting
    • Fortmedica s.r.o.
    • Contact: Tomas Fort, M. D.
    • Sub-Investigator: Daniel Groh, M. D.
  • Praha 4, Czechia, 148 00
    • Recruiting
    • GM ordinace s.r.o
    • Contact: David Macharacek, M. D.
  • Praha 6, Czechia, 160 00
    • Recruiting
    • MUDr Sylva Kohoutova
    • Contact: Sylva Kohoutova, M. D.
  • Praha 6, Czechia, 161 00
    • Recruiting
    • Ordinace Optima s.r.o
    • Contact: Radka Majerova, M. D.
  • Praha 6, Czechia, 164 00
    • Recruiting
    • MUDr. Lenka Fejfarova
    • Contact: Lenka Fejfarova, M. D.
  • Sokolov, Czechia, 356 01
    • Recruiting
    • Saniga s.r.o.
    • Contact: Zdenek Vlasak, M. D.
  • Teplice, Czechia, 415 01
    • Recruiting
    • MUDr. Jan Bartusek
    • Contact: Jan Bartusek, M. D.
  • Zlín, Czechia, 760 01
    • Recruiting
    • A-MEDICOS s.r.o.
    • Contact: Alena Malikova, M. D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Device: Placebo; water based throat spray matching Angiflash for posology, dispensed volume, shape and size.; Other Names: Placebo throat spray
Experimental: Angiflash	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.; Other Names: Seawater based throat spray

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Laboratoire de la Mer
• Investigators: Principal Investigator: Ivana Skardova, M.D., MEDIGATE care s.r.o

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Anticipated): May 31, 2018
• Study Completion (Anticipated): September 30, 2018

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis
• Other Study ID Numbers: FLASH-CZ-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No