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

Primary Purpose

Sore Throat

Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Angiflash
Placebo
Sponsored by
Laboratoire de la Mer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sore Throat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • MUDr. Lenka DybovaRecruiting
  • MUDr. Libor HemzskyRecruiting
  • NEFROMED s.r.o.Recruiting
  • MEDIGATE care s.r.oRecruiting
  • MUDr. Petra HoskovaRecruiting
  • MUDr. Jana Dvorakova s.r.o.Recruiting
  • MUDr. Danuse MikeschovaRecruiting
  • Azita s.r.o.Recruiting
  • Fortmedica s.r.o.Recruiting
  • GM ordinace s.r.oRecruiting
  • MUDr Sylva KohoutovaRecruiting
  • Ordinace Optima s.r.oRecruiting
  • MUDr. Lenka FejfarovaRecruiting
  • Saniga s.r.o.Recruiting
  • MUDr. Jan BartusekRecruiting
  • A-MEDICOS s.r.o.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Angiflash

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Sore Throat Relief
Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)

Secondary Outcome Measures

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
Sore Throat Pain Intensity
Change from baseline of the Sore Throat Pain Intensity using a Visual Analog Scale (VAS) (STPIS)
Difficulty Swallowing
Change from baseline of the difficulty of swallowing using a VAS (DSS)
Swollen Throat
Change from baseline of the swollen throat using a VAS (SwoTS)
Overall efficacy assessed by the physician
Overall efficacy assessed by the physician using a 5-point descriptive scale
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
Product Satisfaction
Assessment of the overall satisfaction using a 5-point descriptive scale
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.

Full Information

First Posted
November 16, 2017
Last Updated
December 21, 2017
Sponsor
Laboratoire de la Mer
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1. Study Identification

Unique Protocol Identification Number
NCT03369132
Brief Title
Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire de la Mer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Angiflash
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Angiflash
Other Intervention Name(s)
Seawater based throat spray
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo throat spray
Intervention Description
water based throat spray matching Angiflash for posology, dispensed volume, shape and size.
Primary Outcome Measure Information:
Title
Sore Throat Relief
Description
Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)
Time Frame
Over the first three days
Secondary Outcome Measure Information:
Title
Sore Throat Individual Symptoms Relief
Description
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
Time Frame
Day 1, 2, 3, 4, 5, 5, 7 to 8.
Title
Sore Throat Pain Intensity
Description
Change from baseline of the Sore Throat Pain Intensity using a Visual Analog Scale (VAS) (STPIS)
Time Frame
Day 1, 2, 3, 4, 5, 5, 7 to 8.
Title
Difficulty Swallowing
Description
Change from baseline of the difficulty of swallowing using a VAS (DSS)
Time Frame
Day 1, 2, 3, 4, 5, 5, 7 to 8.
Title
Swollen Throat
Description
Change from baseline of the swollen throat using a VAS (SwoTS)
Time Frame
Day 1, 2, 3, 4, 5, 5, 7 to 8.
Title
Overall efficacy assessed by the physician
Description
Overall efficacy assessed by the physician using a 5-point descriptive scale
Time Frame
Day 8
Title
Compliance: assessment of the number of use per day and the number of spray per use
Description
Assessment of the patient usage: frequency per day and number of spray per use
Time Frame
Day 1, 2, 3, 4, 5, 5, 7 to 8.
Title
Product Satisfaction
Description
Assessment of the overall satisfaction using a 5-point descriptive scale
Time Frame
Day 8
Title
Incidence of adverse events occuring during the study
Description
Number of adverse events and serious events occuring during the study and evaluation of the severity and causality.
Time Frame
Day 1, 2, 3, 4, 5, 5, 7 to 8.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaelle Naelten, Pharm.D,Ph.D
Phone
+33 (0)299 215 387
Email
gaelle.naelten@perrigo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Gavard, Ph.D.
Phone
+33 (0)256 521 017
Email
olivia.gavard@perrigo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivana Skardova, M.D.
Organizational Affiliation
MEDIGATE care s.r.o
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUDr. Lenka Dybova
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lenka Dybova, M. D.
Facility Name
MUDr. Libor Hemzsky
City
Choltice
ZIP/Postal Code
533 61
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Libor Hemzsky, M. D.
Facility Name
NEFROMED s.r.o.
City
Dejvice
ZIP/Postal Code
160 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krisitina Sadilkova, M. D.
Facility Name
MEDIGATE care s.r.o
City
Hradec Králové
ZIP/Postal Code
500 09
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivana Skardova, M. D.
First Name & Middle Initial & Last Name & Degree
Jan Skarda, M. D.
Facility Name
MUDr. Petra Hoskova
City
Hradec Králové
ZIP/Postal Code
500 09
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Hoskova, M. D.
Facility Name
MUDr. Jana Dvorakova s.r.o.
City
Hradec Králové
ZIP/Postal Code
500 11
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jana Dvorakova, M. D.
Facility Name
MUDr. Danuse Mikeschova
City
Karlovy Vary
ZIP/Postal Code
360 17
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Macharacek, M. D.
Facility Name
Azita s.r.o.
City
Malšice
ZIP/Postal Code
108 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azita Gebauerova, M. D.
Facility Name
Fortmedica s.r.o.
City
Praha 4
ZIP/Postal Code
143 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Fort, M. D.
First Name & Middle Initial & Last Name & Degree
Daniel Groh, M. D.
Facility Name
GM ordinace s.r.o
City
Praha 4
ZIP/Postal Code
148 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Macharacek, M. D.
Facility Name
MUDr Sylva Kohoutova
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylva Kohoutova, M. D.
Facility Name
Ordinace Optima s.r.o
City
Praha 6
ZIP/Postal Code
161 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radka Majerova, M. D.
Facility Name
MUDr. Lenka Fejfarova
City
Praha 6
ZIP/Postal Code
164 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lenka Fejfarova, M. D.
Facility Name
Saniga s.r.o.
City
Sokolov
ZIP/Postal Code
356 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zdenek Vlasak, M. D.
Facility Name
MUDr. Jan Bartusek
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Bartusek, M. D.
Facility Name
A-MEDICOS s.r.o.
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alena Malikova, M. D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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