Sore ThroatPhase 3NCT03282045
Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat
A Phase 3 study testing Lysobact Complete Sprey, Tantum Verde® Spray and Pharyngal® Oromucosal Spray in people with Sore Throat, run by Bosnalijek D.D at 1 site in Bosnia and Herzegovina.
Trial summary
The primary objective of this multicenter, single-blind, randomized, placebo-controlled, prospective, comparative study with parallel design and 4-arms is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and… 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?
- Lysobact Complete Sprey, Tantum Verde® Spray and Pharyngal® Oromucosal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- Oct 2016to 24 May 2018
- Phase
- Phase 3
- 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
- Patients with acute tonsillo-pharyngitis symptoms in common cold and by using a scale-based symptom Tonsillo-Pharyngitis Assessment (TPA) as an objective finding of pharyngeal infection, with a score of ≥5
- Patients who will be treated only on a symptomatic treatment basis, and with a prescribed a oropharyngeal spray
- Patients, 18 years of age and above, who provided an informed consent
- Patients with a sore-throat of recent onset, symptoms initiated ≤48 hours
- Patients with sore throat pain rated ≥66 mm on the Sore Throat Pain Intensity Scale (STPIS)
- Patients with difficulty in swallowing rated ≥50 mm on Difficulty Swallowing Scale (DSS)
- Patients with a sensation of swollen throat rated ≥33 mm on the Swollen Throat Scale (SwoTS)
Who cannot join
- Patients who had any previous (within 4 hours prior to screening examination) throat lozenge treatment/use
- Patients who had used any flu-preparation which contains any analgesic ingredient such as paracetamol, ibuprofen or acetylsalicylic acid (ASA) along with a decongestant
- Patients who had analgesic use (any) 4 hours prior to the screening examination
- Patients who are prescribed an antibiotic use before the screening visit and are entitled to use antibiotics during the course of this non-interventional study
- Patients with a known hypersensitivity to active/inactive ingredients of medications which is prescribed for the symptomatic treatment of sore throat
- Patients with known hypersensitiveness to egg white and other allergens
- Patients who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
University Clinical Center of the Republic of Srpska, ENT Clinic, Banja Luka, Bosnia and Herzegovina
Banja Luka, 78000
About this study
Official title: A Multicenter, Single-blind, Randomized, Placebo-controlled Comparative Study on Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® Spray and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat in Common Cold
The primary objective of this multicenter, single-blind, randomized, placebo-controlled, prospective, comparative study with parallel design and 4-arms is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
Read the detailed description
This study will be conducted in approximately 3 centers in Bosnia Herzegovina and in 4 centers in Turkey.
Primary objective:
The primary objective of this study is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
Secondary objective(s):
- Safety evaluation of Lysobact Complete Spray®, Tantum Verde® Spray, Pharyngal® Oromucosal Spray, based on the frequency and nature of adverse events occurring during treatment period.
- Extent of change in difficulty in swallowing, evaluated on the basis of Difficulty in Swallowing Scale (DSS), on Day 2, Day 4 and Day 6, as compared with baseline.
- Extent of change in swollen throat evaluation based on Swollen Throat Scale (STS) on Day 2, Day 4 and Day 6, as compared with baseline.
- Change in frequency of study treatment applications on Day 2, Day 4 and Day 6, as compared with baseline.
Test product: Lysobact Complete Spray® Active comparator product: Tantum Verde® Spray Active comparator product: Pharyngal® Oromucosal Spray Placebo product: Placebo
Primary endpoint:
- Primary endpoint is the change from baseline to Day 6 in mean VAS score for STPIS.
Secondary endpoint(s):
Secondary endpoints are as follows:
- change from baseline to Day 6 in mean VAS score for DSS
- change from baseline to Day 6 in mean VAS score for SwoTS
- change from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS and SwoTS
- percent improvement from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS and SwoTS
- Incidence of adverse events and relationship to the study treatments
- Incidence of serious adverse events and relationship to the study treatments
Statistical methods:
All patients who have received at least one dose of any study medication will be included in the safety evaluation (safety population). Patients who have completed all visits according to the protocol will be included in the efficacy population. The superiority and inferiority of Lysobact Complete Spray® will be tested in hierarchical order by the comparison of the mean change of VAS scores [Sore Throat Pain Intensity Scale (STPIS)] from baseline to Day 2, 4 and 6.
Planned treatment duration is 5 days. Safety will be followed-up until Day 6. End of study is defined as the end of the follow up period for the last patient.
- Conditions
- Sore Throat
- Being tested
- Lysobact Complete Sprey, Tantum Verde® Spray, Pharyngal® Oromucosal Spray, Placebo
- Keywords
- acute sore throat, lysobact
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysobact Complete SpreyDrug
Inhaling spray
Tantum Verde® SprayDrug
Inhaling spray
Pharyngal® Oromucosal SprayDrug
Inhaling spray
PlaceboDrug
Inhaling spray
| Study group | Role | What they receive |
|---|---|---|
| Lysobact Complete Sprey | Experimental | Lysobact Complete Sprey
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open
Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times and one press of the spray pump release 0.20 mL of the solution containing 4 mg lysozyme, 0.3 mg cetylpyridine and 0.1 mg lidocaine hydrochloride. Receives: Drug: Lysobact Complete Sprey |
| Tantum Verde® Spray | Active comparator | Tantum Verde® Spray
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open.
Dose regimen: Sprayed 4 to 8 doses, 2 to 6 times a day. One press means one dose. Receives: Drug: Tantum Verde® Spray |
| Pharyngal® Oromucosal Spray | Active comparator | Pharyngal® Oromucosal Spray
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open.
Dose regimen: Sprayed 2 to 4 doses, repeated 6 to 10 times per day. One press of the pump (one dose) releases 0.14 ml of the solution with 0.28 mg chlorhexidine digluconate and 0.07 mg of lidocaine hydrochloride. Receives: Drug: Pharyngal® Oromucosal Spray |
| Placebo | Placebo comparator | Route of administration: Sprayed directly toward the affected area with the applicator while the mouth is wide open.
Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators
The primary objective of this study is to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study startOct 2016
- Primary completion24 May 2018
- Study completion24 May 2018
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bosnalijek D.D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MonitorCRO
- Responsible party
- Sponsor
- Investigators
- OZGUN ENVER, MD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282045
- Sponsor's protocol ID
- BOS_CS_01
- Status last verified
- Mar 2021
- First submitted
- 11 Jul 2017
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-blind, Randomized, Placebo-controlled Comparative Study on Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® Spray and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat in Common Cold
- ClinicalTrials.gov ID
- NCT03282045
- Acronym / sponsor ID
- BOS_CS_01
- Conditions
- Sore Throat
- Keywords
- acute sore throat, lysobact
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Bosnalijek D.DIndustry (pharma, biotech, devices)
- Collaborators
- MonitorCRO
- Study start
- Oct 2016
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 13 Sep 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.
The primary objective of this multicenter, single-blind, randomized, placebo-controlled, prospective, comparative study with parallel design and 4-arms is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
Detailed description
This study will be conducted in approximately 3 centers in Bosnia Herzegovina and in 4 centers in Turkey.
Primary objective:
The primary objective of this study is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
Secondary objective(s):
- Safety evaluation of Lysobact Complete Spray®, Tantum Verde® Spray, Pharyngal® Oromucosal Spray, based on the frequency and nature of adverse events occurring during treatment period.
- Extent of change in difficulty in swallowing, evaluated on the basis of Difficulty in Swallowing Scale (DSS), on Day 2, Day 4 and Day 6, as compared with baseline.
- Extent of change in swollen throat evaluation based on Swollen Throat Scale (STS) on Day 2, Day 4 and Day 6, as compared with baseline.
- Change in frequency of study treatment applications on Day 2, Day 4 and Day 6, as compared with baseline.
Test product: Lysobact Complete Spray® Active comparator product: Tantum Verde® Spray Active comparator product: Pharyngal® Oromucosal Spray Placebo product: Placebo
Primary endpoint:
- Primary endpoint is the change from baseline to Day 6 in mean VAS score for STPIS.
Secondary endpoint(s):
Secondary endpoints are as follows:
- change from baseline to Day 6 in mean VAS score for DSS
- change from baseline to Day 6 in mean VAS score for SwoTS
- change from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS and SwoTS
- percent improvement from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS and SwoTS
- Incidence of adverse events and relationship to the study treatments
- Incidence of serious adverse events and relationship to the study treatments
Statistical methods:
All patients who have received at least one dose of any study medication will be included in the safety evaluation (safety population). Patients who have completed all visits according to the protocol will be included in the efficacy population. The superiority and inferiority of Lysobact Complete Spray® will be tested in hierarchical order by the comparison of the mean change of VAS scores [Sore Throat Pain Intensity Scale (STPIS)] from baseline to Day 2, 4 and 6.
Planned treatment duration is 5 days. Safety will be followed-up until Day 6. End of study is defined as the end of the follow up period for the last patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lysobact Complete Sprey | Experimental | Drug: Lysobact Complete SpreyLysobact Complete Sprey Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times and one press of the spray pump release 0.20 mL of the solution containing 4 mg lysozyme, 0.3 mg cetylpyridine and 0.1 mg lidocaine hydrochloride. |
| Tantum Verde® Spray | Active comparator | Drug: Tantum Verde® SprayTantum Verde® Spray Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open. Dose regimen: Sprayed 4 to 8 doses, 2 to 6 times a day. One press means one dose. |
| Pharyngal® Oromucosal Spray | Active comparator | Drug: Pharyngal® Oromucosal SprayPharyngal® Oromucosal Spray Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open. Dose regimen: Sprayed 2 to 4 doses, repeated 6 to 10 times per day. One press of the pump (one dose) releases 0.14 ml of the solution with 0.28 mg chlorhexidine digluconate and 0.07 mg of lidocaine hydrochloride. |
| Placebo | Placebo comparator | Drug: PlaceboRoute of administration: Sprayed directly toward the affected area with the applicator while the mouth is wide open. Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with acute tonsillo-pharyngitis symptoms in common cold and by using a scale-based symptom Tonsillo-Pharyngitis Assessment (TPA) as an objective finding of pharyngeal infection, with a score of ≥5
- Patients who will be treated only on a symptomatic treatment basis, and with a prescribed a oropharyngeal spray
- Patients, 18 years of age and above, who provided an informed consent
- Patients with a sore-throat of recent onset, symptoms initiated ≤48 hours
- Patients with sore throat pain rated ≥66 mm on the Sore Throat Pain Intensity Scale (STPIS)
Key exclusion criteria (7 listed)
- Patients who had any previous (within 4 hours prior to screening examination) throat lozenge treatment/use
- Patients who had used any flu-preparation which contains any analgesic ingredient such as paracetamol, ibuprofen or acetylsalicylic acid (ASA) along with a decongestant
- Patients who had analgesic use (any) 4 hours prior to the screening examination
- Patients who are prescribed an antibiotic use before the screening visit and are entitled to use antibiotics during the course of this non-interventional study
- Patients with a known hypersensitivity to active/inactive ingredients of medications which is prescribed for the symptomatic treatment of sore throat
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 |
|---|---|---|
| Lysobact Complete SpreyInhaling spray | Drug | Lysobact Complete Sprey |
| Tantum Verde® SprayInhaling spray | Drug | Tantum Verde® Spray |
| Pharyngal® Oromucosal SprayInhaling spray | Drug | Pharyngal® Oromucosal Spray |
| PlaceboInhaling spray | Drug | Placebo |
Primary outcome
to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators
Time frame: Day 6
The primary objective of this study is to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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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.
OZGUN ENVER, MD principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lysobact Complete Sprey, Tantum Verde® Spray and Pharyngal® Oromucosal Spray in people with Sore Throat, run by Bosnalijek D.D at 1 site in Bosnia and Herzegovina.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators (time frame: Day 6). 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 16 Mar 2021.