Clinical trial NCT03369132: Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief
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
Overall status: UNKNOWN
Phase: NA
Conditions: Sore Throat
Lead sponsor: Laboratoire de la Mer
Sponsor class: INDUSTRY
First posted: 2017-12-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Sore Throat Relief
timeFrame: Over the first three days
Secondary outcomes:
measure: Sore Throat Individual Symptoms Relief
timeFrame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
measure: Sore Throat Pain Intensity
timeFrame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
measure: Difficulty Swallowing
timeFrame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
measure: Swollen Throat
timeFrame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
measure: Overall efficacy assessed by the physician
timeFrame: Day 8
measure: Compliance: assessment of the number of use per day and the number of spray per use
timeFrame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
measure: Product Satisfaction
timeFrame: Day 8
measure: Incidence of adverse events occuring during the study
timeFrame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: MUDr. Lenka Dybova
city: Choltice
country: Czechia
facility: MUDr. Libor Hemzsky
city: Dejvice
country: Czechia
facility: NEFROMED s.r.o.
city: Hradec Králové
country: Czechia
facility: MEDIGATE care s.r.o
city: Hradec Králové
country: Czechia
facility: MUDr. Petra Hoskova
city: Hradec Králové
country: Czechia
facility: MUDr. Jana Dvorakova s.r.o.
city: Karlovy Vary
country: Czechia
facility: MUDr. Danuse Mikeschova
city: Malšice
country: Czechia
facility: Azita s.r.o.
city: Praha 4
country: Czechia
facility: Fortmedica s.r.o.
city: Praha 4
country: Czechia
facility: GM ordinace s.r.o
city: Praha 6
country: Czechia
facility: MUDr Sylva Kohoutova
city: Praha 6
country: Czechia
facility: Ordinace Optima s.r.o
city: Praha 6
country: Czechia
facility: MUDr. Lenka Fejfarova
city: Sokolov
country: Czechia
facility: Saniga s.r.o.
city: Teplice
country: Czechia
facility: MUDr. Jan Bartusek
city: Zlín
country: Czechia
facility: A-MEDICOS s.r.o.
Study officials:
affiliation: MEDIGATE care s.r.o
name: Ivana Skardova, M.D.
role: PRINCIPAL_INVESTIGATOR
References: