Sore ThroatFLASHNCT03369132
Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief
A study testing Angiflash in people with Sore Throat, run by Laboratoire de la Mer at 16 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sore Throat
- What is being tested?
- Angiflash
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 16 sitesCzechia
- Study dates
- 6 Nov 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Czechia16 sites, 16 recruiting
- Recruiting
MUDr. Lenka Dybova
Brno, 602 00
Lenka Dybova, M. D.
- Recruiting
MUDr. Libor Hemzsky
Choltice, 533 61
Libor Hemzsky, M. D.
- Recruiting
NEFROMED s.r.o.
Dejvice, 160 00
Krisitina Sadilkova, M. D.
- Recruiting
MEDIGATE care s.r.o
Hradec Králové, 500 09
Ivana Skardova, M. D.
Jan Skarda, M. D.
- Recruiting
MUDr. Petra Hoskova
Hradec Králové, 500 09
Petra Hoskova, M. D.
- Recruiting
MUDr. Jana Dvorakova s.r.o.
Hradec Králové, 500 11
Jana Dvorakova, M. D.
- Recruiting
MUDr. Danuse Mikeschova
Karlovy Vary, 360 17
David Macharacek, M. D.
- Recruiting
Azita s.r.o.
Malšice, 108 00
Azita Gebauerova, M. D.
- Recruiting
Fortmedica s.r.o.
Prague, 143 00
Tomas Fort, M. D.
Daniel Groh, M. D.
- Recruiting
GM ordinace s.r.o
Prague, 148 00
David Macharacek, M. D.
- Recruiting
MUDr Sylva Kohoutova
Prague, 160 00
Sylva Kohoutova, M. D.
- Recruiting
Ordinace Optima s.r.o
Prague, 161 00
Radka Majerova, M. D.
- Recruiting
MUDr. Lenka Fejfarova
Prague, 164 00
Lenka Fejfarova, M. D.
- Recruiting
Saniga s.r.o.
Sokolov, 356 01
Zdenek Vlasak, M. D.
- Recruiting
MUDr. Jan Bartusek
Teplice, 415 01
Jan Bartusek, M. D.
- Recruiting
A-MEDICOS s.r.o.
Zlín, 760 01
Alena Malikova, M. D.
About this study
Official title: 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.
- Conditions
- Sore Throat
- Being tested
- Angiflash, Placebo
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngiflashDevice
Also called Seawater based throat spray
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.
PlaceboDevice
Also called Placebo throat spray
water based throat spray matching Angiflash for posology, dispensed volume, shape and size.
| Study group | Role | What they receive |
|---|---|---|
| Angiflash | Experimental | Not described Receives: Device: Angiflash |
| Placebo | Placebo comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sore Throat Relief
Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)
Measured: Over the first three days
Secondary outcomes (8)
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
Measured: 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)
Measured: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Difficulty Swallowing
Change from baseline of the difficulty of swallowing using a VAS (DSS)
Measured: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Swollen Throat
Change from baseline of the swollen throat using a VAS (SwoTS)
Measured: 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
Measured: 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
Measured: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Product Satisfaction
Assessment of the overall satisfaction using a 5-point descriptive scale
Measured: 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.
Measured: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start6 Nov 2017
- Primary completion31 May 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoire de la Mer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivana Skardova, M.D., Principal investigator, MEDIGATE care s.r.o
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369132
- Sponsor's protocol ID
- FLASH-CZ-2017-01
- Acronym
- FLASH
- Status last verified
- Dec 2017
- First submitted
- 16 Nov 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief: a Prospective, Randomized, Double-blind, Placebo-controlled, Multicentre Clinical Study
- ClinicalTrials.gov ID
- NCT03369132
- Acronym / sponsor ID
- FLASH / FLASH-CZ-2017-01
- Conditions
- Sore Throat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Laboratoire de la MerIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiflash | Experimental | Device: Angiflash |
| Placebo | Placebo comparator | Device: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (36 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngiflashAlso: Seawater based throat spraythroat 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. | Device | Angiflash |
| PlaceboAlso: Placebo throat spraywater based throat spray matching Angiflash for posology, dispensed volume, shape and size. | Device | Placebo |
Primary outcome
Sore Throat Relief
Time frame: Over the first three days
Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)
8 secondary outcomes
Sore Throat Individual Symptoms Relief
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Sore Throat Pain Intensity
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Difficulty Swallowing
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Swollen Throat
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Overall efficacy assessed by the physician
Time frame: Day 8
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.
Product Satisfaction
Time frame: Day 8
Incidence of adverse events occuring during the study
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivana Skardova, M.D. principal investigator
MEDIGATE care s.r.o
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiflash in people with Sore Throat, run by Laboratoire de la Mer at 16 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaelle Naelten, Pharm.D,Ph.D (+33 (0)299 215 387, gaelle.naelten@perrigo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sore Throat Relief (time frame: Over the first three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.