NCT03369132UnknownNot Applicable
Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief: a Prospective, Randomized, Double-blind, Placebo-controlled, Multicentre Clinical Study
Laboratoire de la Mer16 sites in 1 country360 target enrollmentStarted: November 6, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Laboratoire de la Mer
- Enrollment
- 360
- Locations
- 16
- Primary Endpoint
- Sore Throat Relief
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (male or female) aged ≥ 18 years old.
- •Patients with complaint of sore throat ≤ 72h.
- •Sore throat exclusively due to upper respiratory tract infection (tonsillitis, pharyngitis, rhinopharyngitis).
- •Clinical confirmation by the physician for the presence of typical signs (spontaneous pain, local inflammation) of acute pharyngitis or tonsillitis.
- •Pain intensity scored by patient on the 5-point descriptive pain intensity scale as slight, mild or moderate.
- •Willingness to provide written informed consent prior to perform of any study related procedure.
- •Subjects agreeing to follow the study requirements during the whole study period (including forbidden medication and food supplements).
- •Subjects agreeing not to modify their lifestyle habits during the whole study period (diet, physical activity).
- •Subject affiliated to social security.
- •Subject able to understand verbal and written local language and in capacity to fill-in patient diary by himself/herself.
Exclusion Criteria
- •Previous history of allergy or known intolerance to one of the following formulation ingredients: seawater, vegetable glycerin, mint, lemon, acacia honey, propolis, essential oils.
- •Active Smokers.
- •Fever > 38°C at randomization.
- •Past or current throat phlegmon.
- •Past or current seasonal allergy.
- •Past or current asthma.
- •Past or current chronic rhinosinusitis.
- •Past or current chronic obstructive pulmonary disease (COPD).
- •Past or current ENT (Ear, Nose and Throat) cancer.
- •Acute rhinosinusitis.
- •Controlled or uncontrolled diabetes.
- •Gastroesophageal reflux disease (GERD).
- •Known immunodeficiency.
- •Any painful condition that may distract attention from sore throat pain (ex: mouth ulcers etc.) or that requires analgesic usage.
- •Any disease that may interfere with the study aim from investigator's opinion.
- •Evidence of mouth breathing or severe coughing.
- •Patient with severe pain intensity on 5-point descriptive pain intensity scale.
- •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.
- •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.
- •Known liver disease or hypersensitivity to paracetamol.
- •Pregnant, breastfeeding or seeking pregnancy women.
- •Positive result from rapid strep throat test.
- •Subjects already included once in this study.
- •Subjects participating in another clinical trial or in the exclusion period to another study.
- •Subjects having a member of his/her home who is currently participating to this study.
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Device)
Angiflash
Experimental
Intervention: Angiflash (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Swollen Throat(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
- Sore Throat Pain Intensity(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
- Difficulty Swallowing(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
- Overall efficacy assessed by the physician(Day 8)
- Incidence of adverse events occuring during the study(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
- Product Satisfaction(Day 8)
- Sore Throat Individual Symptoms Relief(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
- Compliance: assessment of the number of use per day and the number of spray per use(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
Investigators
Study Sites (16)
Loading locations...
Similar Trials
Unknown
Not Applicable
A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Lavandula Angustifolia Containing Nasal Spray Medical Device in Preventing Deterioration of COVID-19 in Symptomatic PatientsCOVID-19 InfectionNCT04974190The Grasses of Eden Ltd550
Completed
Not Applicable
Sterimar Allergic RhinitisAllergic RhinitisNCT05506709Church & Dwight Company, Inc.59
Completed
Not Applicable
Seawater Nasal Wash to Relieve COVID-19 Nasal Symptoms and Reduce SARS-CoV-2 Viral Load.URTI - Viral Upper Respiratory Tract InfectionSARS-CoV2 Infection (COVID-19)NCT04916639Laboratoire de la Mer370
Completed
Phase 3
Study In Adults And Adolescents With Seasonal Allergic RhinitisSeasonal Allergic RhinitisHayfeverRhinitis, Allergic, SeasonalNCT00115622GlaxoSmithKline304
Completed
Not Applicable
Clinical Trial of a Mouth and Throat Rinse for the Treatment of Acute Sore ThroatSore-throatUpper Respiratory InfectionNCT06244615Dr. August Wolff GmbH & Co. KG Arzneimittel154