AllergyNCT03975257
Ectoin Lozenges (EHT02) in the Treatment of Oropharyngeal Allergic Symptoms
A study testing Medical Device: Ectoin Lozenge in people with Allergy, run by Bitop AG at 8 sites in Germany.
Trial summary
The goal of this multicentric, prospective, randomised, controlled study (§23b German Act on Medical Devices (MPG)) is to investigate the efficacy of Ectoin Lozenges (EHT02) in treatment and prevention of oropharyngeal allergic symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy
- What is being tested?
- Medical Device: Ectoin Lozenge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 8 sitesGermany
- Study dates
- 4 Feb 2019to 12 Sep 2019
- 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
- initiation of a SLIT
- minimum age of 18 years
- written consent of the patient
Who cannot join
- Surgical Procedures in the mouth and throat region prior to the study
- patients with known intolerance to one of the substances used
- pregnant or breast-feeding women
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Facharzt f. HNO-Heilkunde
Aachen
Fachärztin für Hals-Nasen-Ohrenheilkunde
Bad Schörnborn, 76669
Facharzt f. Dermatologie ruhrDerm GbR
Bochum, 44803
Facharzt für Lungen- und Bronchialheilkunde
Bonn, 53119
Facharzt für Haut und Geschlechtskrankheiten
Gelsenkirchen
Arzt für Hals-Nasen-Ohrenheilkunde, Allergologie, Umweltmedizin, Naturheilverfahren, Flugmedizin, Taucherarzt (GTÜM)
Heidelberg
Fachärztin f. HNO-Heilkunde, Allergologie
Jülich, 52428
Facharzt für Hals-Nasen-Ohrenheilkunde, Allergo GmbH Stuttgart, Klinische Prüfstelle Schorndorf
Schorndorf
About this study
Official title: Application of Ectoin Lozenges (EHT02) in Patients With Oropharyngeal Allergic Symptoms
The goal of this multicentric, prospective, randomised, controlled study (§23b German Act on Medical Devices (MPG)) is to investigate the efficacy of Ectoin Lozenges (EHT02) in treatment and prevention of oropharyngeal allergic symptoms.
Read the detailed description
The immune system of humans can show an overreaction to proteins from the environment (allergic reaction). Triggers of these allergic reactions may be e.g. pollen, dust mites, mold or animal hair. Common allergic symptoms include itchy, stuffy, runny nose, sneezing, itchy and watery eyes and respiratory complaints. Allergen-specific immunotherapy is the only treatment that eliminates the causes of allergic disease. An example of such immunotherapies is the sublingual immunotherapy (SLIT). During SLIT, side effects may occur such as local oropharyngeal reactions, e.g. manifesting as itching, swelling or irritation.
The current study aims to investigate the efficacy of Ectoin Lozenges (EHT02) in patients suffering from oropharyngeal allergic symptoms. The symptoms are induced by SLIT.
Patients are dedicated to one of three groups: a) preventive application of Ectoin Lozenges before SLIT-initiation, b) therapeutic application of Ectoin Lozenges after SLIT-initiation or c) control: SLIT-initiation without application of Ectoin Lozenges.
The symptoms itching, swelling and irritation of mouth, lips and throat will be documented by the patients once 30 minutes after SLIT-initiation.
- Conditions
- Allergy
- Being tested
- Medical Device: Ectoin Lozenge
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device: Ectoin LozengeDevice
Also called EHT02
Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use
| Study group | Role | What they receive |
|---|---|---|
| Preventive application of EHT02 | Experimental | application of one Ectoin Lozenge before SLIT-initiation Receives: Device: Medical Device: Ectoin Lozenge |
| Therapeutic application of EHT02 | Experimental | application of one Ectoine Lozenge after SLIT-initiation Receives: Device: Medical Device: Ectoin Lozenge |
| No application of EHT02 | No intervention | SLIT-Initiation without Ectoin Lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative score of allergic symptoms of the lips evaluated by the patient
about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the lips (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)
Measured: about 30 minutes after SLIT-initiation
cumulative score of allergic symptoms of the mouth evaluated by the patient
about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the mouth (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)
Measured: about 30 minutes after SLIT-initiation
cumulative score of allergic symptoms of the throat evaluated by the patient
about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the throat (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)
Measured: about 30 minutes after SLIT-initiation
Secondary outcomes (1)
Incidence of adverse events/serious adverse events
All occurring adverse events/serious adverse events will be documented during the study.
Measured: through study visit (participation encompasses 1 visit of approx. 60 min duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start4 Feb 2019
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies 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
- None (open label)
- Enrolment
- 90 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
- NCT03975257
- Sponsor's protocol ID
- btph-021-2018-EHT02
- Status last verified
- Dec 2019
- First submitted
- 22 Jan 2019
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ectoin Lozenges (EHT02) in Patients With Oropharyngeal Allergic Symptoms
- ClinicalTrials.gov ID
- NCT03975257
- Acronym / sponsor ID
- btph-021-2018-EHT02
- Conditions
- Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 5 Jun 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 multicentric, prospective, randomised, controlled study (§23b German Act on Medical Devices (MPG)) is to investigate the efficacy of Ectoin Lozenges (EHT02) in treatment and prevention of oropharyngeal allergic symptoms.
Detailed description
The immune system of humans can show an overreaction to proteins from the environment (allergic reaction). Triggers of these allergic reactions may be e.g. pollen, dust mites, mold or animal hair. Common allergic symptoms include itchy, stuffy, runny nose, sneezing, itchy and watery eyes and respiratory complaints. Allergen-specific immunotherapy is the only treatment that eliminates the causes of allergic disease. An example of such immunotherapies is the sublingual immunotherapy (SLIT). During SLIT, side effects may occur such as local oropharyngeal reactions, e.g. manifesting as itching, swelling or irritation.
The current study aims to investigate the efficacy of Ectoin Lozenges (EHT02) in patients suffering from oropharyngeal allergic symptoms. The symptoms are induced by SLIT.
Patients are dedicated to one of three groups: a) preventive application of Ectoin Lozenges before SLIT-initiation, b) therapeutic application of Ectoin Lozenges after SLIT-initiation or c) control: SLIT-initiation without application of Ectoin Lozenges.
The symptoms itching, swelling and irritation of mouth, lips and throat will be documented by the patients once 30 minutes after SLIT-initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preventive application of EHT02 | Experimental | Device: Medical Device: Ectoin Lozengeapplication of one Ectoin Lozenge before SLIT-initiation |
| Therapeutic application of EHT02 | Experimental | Device: Medical Device: Ectoin Lozengeapplication of one Ectoine Lozenge after SLIT-initiation |
| No application of EHT02 | No intervention | –SLIT-Initiation without Ectoin Lozenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- initiation of a SLIT
- minimum age of 18 years
- written consent of the patient
Key exclusion criteria (3 listed)
- Surgical Procedures in the mouth and throat region prior to the study
- patients with known intolerance to one of the substances used
- pregnant or breast-feeding women
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 |
|---|---|---|
| Medical Device: Ectoin LozengeAlso: EHT02Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use | Device | Preventive application of EHT02, Therapeutic application of EHT02 |
Primary outcome
cumulative score of allergic symptoms of the lips evaluated by the patient
Time frame: about 30 minutes after SLIT-initiation
about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the lips (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)
cumulative score of allergic symptoms of the mouth evaluated by the patient
Time frame: about 30 minutes after SLIT-initiation
about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the mouth (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)
cumulative score of allergic symptoms of the throat evaluated by the patient
Time frame: about 30 minutes after SLIT-initiation
about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the throat (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)
1 secondary outcome
Incidence of adverse events/serious adverse events
Time frame: through study visit (participation encompasses 1 visit of approx. 60 min duration)
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 20 Oct 2026.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device: Ectoin Lozenge in people with Allergy, run by Bitop AG at 8 sites 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 3 inclusion and 3 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
cumulative score of allergic symptoms of the lips evaluated by the patient (time frame: about 30 minutes after SLIT-initiation). The study lists 3 primary outcomes in all. 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 20 Oct 2026.