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

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ClinicalTrials.gov Identifier: NCT03369132
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sore Throat Device: Angiflash Device: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief: a Prospective, Randomized, Double-blind, Placebo-controlled, Multicentre Clinical Study
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
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 Name: Seawater based throat spray

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




Primary Outcome Measures :
  1. Sore Throat Relief [ Time Frame: Over the first three days ]
    Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)


Secondary Outcome Measures :
  1. Sore Throat Individual Symptoms Relief [ Time Frame: 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

  2. Sore Throat Pain Intensity [ Time Frame: 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)

  3. Difficulty Swallowing [ Time Frame: Day 1, 2, 3, 4, 5, 5, 7 to 8. ]
    Change from baseline of the difficulty of swallowing using a VAS (DSS)

  4. Swollen Throat [ Time Frame: Day 1, 2, 3, 4, 5, 5, 7 to 8. ]
    Change from baseline of the swollen throat using a VAS (SwoTS)

  5. Overall efficacy assessed by the physician [ Time Frame: Day 8 ]
    Overall efficacy assessed by the physician using a 5-point descriptive scale

  6. Compliance: assessment of the number of use per day and the number of spray per use [ Time Frame: Day 1, 2, 3, 4, 5, 5, 7 to 8. ]
    Assessment of the patient usage: frequency per day and number of spray per use

  7. Product Satisfaction [ Time Frame: Day 8 ]
    Assessment of the overall satisfaction using a 5-point descriptive scale

  8. Incidence of adverse events occuring during the study [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369132


Contacts
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Contact: Gaelle Naelten, Pharm.D,Ph.D +33 (0)299 215 387 gaelle.naelten@perrigo.com
Contact: Olivia Gavard, Ph.D. +33 (0)256 521 017 olivia.gavard@perrigo.com

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

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Responsible Party: Laboratoire de la Mer
ClinicalTrials.gov Identifier: NCT03369132     History of Changes
Other Study ID Numbers: FLASH-CZ-2017-01
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases