Acute Viral PharyngitisNCT03943186
Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.
An observational study of Acute Viral Pharyngitis, run by Bitop AG at 1 site in Germany.
Trial summary
The goal of this non-interventional study is to investigate the safety, efficacy and tolerability of Ectoin Lozenges Honey Lemon (EHT02) compared to lozenges containing hyaluronic acid and islandic moss in the treatment of acute viral pharyngitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Viral Pharyngitis
- What is being tested?
- Ectoin Lozenges Honey Lemon and Hyaluronic Acid/Icelandic moss Lozenges
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- 13 Dec 2018to 13 May 2019
- Phase
- Observational
- 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
Study population: patients diagnosed with acute viral pharyngitis
Who may be able to join
- patients with acute viral pharyngitis
Who cannot join
- patients with known intolerance to one of the substances used
- Pregnancy
- Surgical Procedures in the mouth and throat region prior to the study
- Bacterial Pharyngitis
- symptoms in the throat since more than 5 days
- Contraindications according to the instructions for use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study to Investigate the Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.
The goal of this non-interventional study is to investigate the safety, efficacy and tolerability of Ectoin Lozenges Honey Lemon (EHT02) compared to lozenges containing hyaluronic acid and islandic moss in the treatment of acute viral pharyngitis.
Read the detailed description
The current non-interventional study aims to investigate the efficacy and tolerability of Ectoin Lozenges Honey Lemon in patients suffering from acute viral pharyngitis. Participants receive treatments as part of routine medical care, and participants can choose one of two treatment options: a) Ectoin Lozenges Honey Lemon or b) lozenges containing hyaluronic acid and icelandic moss.
Efficacy will be studied by documentation of the following symptoms:
- pain on swallowing
- hoarseness
- urge to cough
- dry mouth and throat
- redness of oropharynx and larynx
- sore throat
- impairment of free breathing
- general feeling of illness
In parallel, participating patients will document their symptoms over the entire study duration in patient diaries.
The observation takes place over a period of seven days.
- Conditions
- Acute Viral Pharyngitis
- Being tested
- Ectoin Lozenges Honey Lemon, Hyaluronic Acid/Icelandic moss Lozenges
- Keywords
- non-interventional study, Ectoin, Lozenges, Pharyngitis
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ectoin Lozenges Honey LemonDevice
Also called EHT02
application of Ectoin Lozenges (EHT02) in accordance with the instructions for use
Hyaluronic Acid/Icelandic moss LozengesDevice
application of the lozenges in accordance with the instructions for use
| Study group | Role | What they receive |
|---|---|---|
| Ectoin Lozenges Honey Lemon | application of 1 Lozenge every three hours or as often as required, not more than 10 lozenges per day Receives: Device: Ectoin Lozenges Honey Lemon | |
| Hyaluronic acid/Icelandic moss Lozenges | application as often as required, not more than 6 lozenges per day Receives: Device: Hyaluronic Acid/Icelandic moss Lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pharyngitis symptom score evaluated by the physician
The intensity of the symptoms will be graded on a continuous numeric scale, i.e. absent-0, severe-10.
The following signs and symptoms will be documented:
- pain on swallowing
- hoarseness
- urge to cough
- dry mouth and throat
- reddening of oropharynx
- reddening of larynx
- sore throat
- impairment of free breathing
- patient's general condition
Measured: day 1 and day 7
Secondary outcomes (8)
Change in Pharyngitis Symptoms evaluated in patient's diaries
The intensity of the symptoms and signs will be graded on a continuous numeric scale, i.e. absent-0, severe-10.
The following signs and symptoms will be documented:
- pain on swallowing
- hoarseness
- urge to cough
- dry mouth and throat
- sore throat
- impairment of free breathing
- patient's general condition
Measured: 7 days
Change of Saliva production evaluated by the physician
Assessment on a continuous numeric scale (0-no, 10-yes)
Measured: day 7
Evaluation how efficient the treatment is judged by physician
Assessment on a continuous numeric scale (0-bad, 10-very good)
Measured: day 7
Evaluation how efficient the treatment is judged by patient
Assessment on a continuous numeric scale (0-bad, 10-very good)
Measured: 7 days
Evaluation how treatment is tolerated (judged by physician)
Assessment on a continuous numeric scale (0-bad, 10-very good)
Measured: day 7
Evaluation how treatment is tolerated (judged by patients)
Assessment on a continuous numeric scale (0-bad, 10-very good)
Measured: 7 days
Evaluation of compliance evaluated by physician
Assessment on a continuous numeric scale (0-bad, 10-very good)
Measured: day 7
Incidence of adverse events/serious adverse events
All occuring adverse events/serious adverse events will be documented during the entire study period.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start13 Dec 2018
- Primary completion13 May 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Viral PharyngitisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Bilstein, Dr, Study director, CSO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943186
- Sponsor's protocol ID
- btph-014-2018-EHT02
- Status last verified
- Jul 2019
- First submitted
- 21 Jan 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Investigate the Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.
- ClinicalTrials.gov ID
- NCT03943186
- Acronym / sponsor ID
- btph-014-2018-EHT02
- Conditions
- Acute Viral Pharyngitis
- Keywords
- non-interventional study, Ectoin, Lozenges, Pharyngitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 9 May 2019 (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 goal of this non-interventional study is to investigate the safety, efficacy and tolerability of Ectoin Lozenges Honey Lemon (EHT02) compared to lozenges containing hyaluronic acid and islandic moss in the treatment of acute viral pharyngitis.
Detailed description
The current non-interventional study aims to investigate the efficacy and tolerability of Ectoin Lozenges Honey Lemon in patients suffering from acute viral pharyngitis. Participants receive treatments as part of routine medical care, and participants can choose one of two treatment options: a) Ectoin Lozenges Honey Lemon or b) lozenges containing hyaluronic acid and icelandic moss.
Efficacy will be studied by documentation of the following symptoms:
- pain on swallowing
- hoarseness
- urge to cough
- dry mouth and throat
- redness of oropharynx and larynx
- sore throat
- impairment of free breathing
- general feeling of illness
In parallel, participating patients will document their symptoms over the entire study duration in patient diaries.
The observation takes place over a period of seven days.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ectoin Lozenges Honey Lemon | – | Device: Ectoin Lozenges Honey Lemonapplication of 1 Lozenge every three hours or as often as required, not more than 10 lozenges per day |
| Hyaluronic acid/Icelandic moss Lozenges | – | Device: Hyaluronic Acid/Icelandic moss Lozengesapplication as often as required, not more than 6 lozenges per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with acute viral pharyngitis
Key inclusion criteria (1 listed)
- patients with acute viral pharyngitis
Key exclusion criteria (6 listed)
- patients with known intolerance to one of the substances used
- Pregnancy
- Surgical Procedures in the mouth and throat region prior to the study
- Bacterial Pharyngitis
- symptoms in the throat since more than 5 days
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 |
|---|---|---|
| Ectoin Lozenges Honey LemonAlso: EHT02application of Ectoin Lozenges (EHT02) in accordance with the instructions for use | Device | Ectoin Lozenges Honey Lemon |
| Hyaluronic Acid/Icelandic moss Lozengesapplication of the lozenges in accordance with the instructions for use | Device | Hyaluronic acid/Icelandic moss Lozenges |
Primary outcome
Change in Pharyngitis symptom score evaluated by the physician
Time frame: day 1 and day 7
The intensity of the symptoms will be graded on a continuous numeric scale, i.e. absent-0, severe-10. The following signs and symptoms will be documented: * pain on swallowing * hoarseness * urge to cough * dry mouth and throat * reddening of oropharynx * reddening of larynx * sore throat * impairment of free breathing * patient's general condition
8 secondary outcomes
Change in Pharyngitis Symptoms evaluated in patient's diaries
Time frame: 7 days
Change of Saliva production evaluated by the physician
Time frame: day 7
Evaluation how efficient the treatment is judged by physician
Time frame: day 7
Evaluation how efficient the treatment is judged by patient
Time frame: 7 days
Evaluation how treatment is tolerated (judged by physician)
Time frame: day 7
Evaluation how treatment is tolerated (judged by patients)
Time frame: 7 days
Evaluation of compliance evaluated by physician
Time frame: day 7
Incidence of adverse events/serious adverse events
Time frame: 7 days
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 10 Jul 2019.
- 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.
Andreas Bilstein, Dr study director
CSO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Viral Pharyngitis, run by Bitop AG at 1 site in Germany.
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 1 inclusion and 6 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 10 Jul 2019. 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 Germany. 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. 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?
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?
Change in Pharyngitis symptom score evaluated by the physician (time frame: day 1 and day 7). 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 10 Jul 2019.