Sore ThroatNCT04203810
Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)
A study testing Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) and EMSER® Hals-und Rachenspray (throat spray) in people with Sore Throat and Acute Pharyngitis, run by Bitop AG at 12 sites in Germany.
Trial summary
The aim of this multicentre, actively controlled, randomized, open label, parallel group, prospective, comparator study is to collect data on the clinical effectiveness and tolerability of the medical device ERS09 compared to a well-established comparator spray in the symptomatic treatment of sore throat due to acute… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Sore Throat, Acute Pharyngitis, Cough
- What is being tested?
- Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) and EMSER® Hals-und Rachenspray (throat spray)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 12 sitesGermany
- Study dates
- 14 Jan 2020to 4 Dec 2020
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP)/ISO14155 guidelines and local regulation prior to participation in the trial
- Individuals regardless of gender 12 years old or older
- Patients with sore throat due to acute pharyngitis and dry cough, both with an onset of symptoms no more than 72 hours prior to Visit 1
- Sore Throat Pain Intensity Score ≥ 40 mm (measured on a 100 mm visual analogue scale [VAS])
Who cannot join
- Hypersensitivity to Ectoin, Althaea off., Honey or any of the other ingredients of the ERS09 or the comparator
- Fructose intolerance or glucose-galactose malabsorption
- Pregnant or breast-feeding women
- Suspected bacterial pharyngitis
- Individuals younger than 12 years
- Symptoms since more than 72 hours
Show all 9Show fewer
- Use of any pain or cough medication (i.e. analgesic/ anti-pyretic/ anti-inflammatory or mucolytic/ expectorant/ antitussive) within 24 hours preceding enrolment in the study
- Oral lesions or oral surgical procedures within 1 month prior to enrolment in the study
- Patients for who the Investigator believes will not comply with the study protocol (e.g. patients with drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Dr. Pasch
Aachen
Dr. Sondermann
Aachen
Dr. Männer
Arnsberg
Dr. Kienle-Gogolok
Bad Schönborn, 76669
Dr. Ginko
Bonn
Dr. Vent
Cologne
Praxis für Hals-Nasen-Ohren-Heilkunde
Dresden
Dr. Thieme
Duisburg
Dr. Horn
Heidelberg
Dr. Lenzenhuber
Jülich
Dr. Konzelmann
Röthenbach
Reiber
Schorndorf
About this study
Official title: Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) Compared to Saline Spray in Patients Suffering From Sore Throat Due to Acute Pharyngitis and Dry Cough
The aim of this multicentre, actively controlled, randomized, open label, parallel group, prospective, comparator study is to collect data on the clinical effectiveness and tolerability of the medical device ERS09 compared to a well-established comparator spray in the symptomatic treatment of sore throat due to acute pharyngitis and dry cough.
Read the detailed description
The aim of this study is to collect data on the clinical effectiveness and tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) compared to the well-established comparator spray EMSER® Hals- und Rachenspray (both medical devices) in the symptomatic treatment of sore throat due to acute pharyngitis and dry cough.
The principle mode of action of ectoine is based on the physical interaction of the compatible solute with water and the resulting stabilizing effects of the ectoine hydro complex on the epithelial tissue treated. Althaea has so-called mucilaginous effects, that means generally a shielding of the irritated mucus membranes by thin polysaccharide layers. Such mucilaginous polymer layers lead to rehydration, coating of peripheral sensory receptors, and therefore to a reduction of throat irritation and dry coughing. Honey acts predominantly as demulcent with its viscous liquid constitution based on mainly fructose and glucose. The combination of all three substances may result in a multi-modal treatment of the symptoms of sore throat and dry cough.
Patients will be randomly assigned to one of the following treatment groups:
- treatment with ERS09
- treatment with comparator (EMSER® Hals- und Rachenspray)
Patients' symptoms will be documented by the physician in investigator questionnaires at visits 1, 2 and 3. At visit 1 the patients will receive a patient diary for daily documentation of their symptoms. In addition, patients and investigators will be asked to evaluate the overall effectiveness and tolerability of ERS09 spray at visit 3.
- Conditions
- Sore Throat, Acute Pharyngitis, Cough
- Being tested
- Ectoin® Mouth and Throat Spray Althaea Honey (ERS09), EMSER® Hals-und Rachenspray (throat spray)
- Medical subject headings
- Pharyngitis, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)Device
4 puffs to be administered as needed several times a day for patients aged ≥ 12 years. A maximum of 10 applications per day should not be exceeded.
EMSER® Hals-und Rachenspray (throat spray)Device
1 to 3 puffs to be administered several times a day
| Study group | Role | What they receive |
|---|---|---|
| Ectoin® Mouth and Throat Spray Althaea Honey | Experimental | 4 puffs to be administered as needed several times a day for patients aged ≥ 12 years. A maximum of 10 applications per day should not be exceeded. Receives: Device: Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) |
| EMSER® Hals- und Rachenspray (throat spray) | Active comparator | 1 to 3 puffs to be administered several times a day Receives: Device: EMSER® Hals-und Rachenspray (throat spray) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mean total symptom score
Baseline adjusted mean change of patient's assessment of total symptom score (patient diary) averaged over 7 treatment days
Measured: 7 days
Change of daily symptom score
Baseline adjusted daily change of patient's assessment of total symptom score (patient diary)
Measured: 1 day
Secondary outcomes (1)
Adverse events (AE) and serious adverse events (SAE) during treatment phase
Evaluation of severity, nature and frequency of AEs/SAEs and their relationship to the investigational devices
Measured: 7 +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start14 Jan 2020
- Primary completion4 Dec 2020
- Study completion4 Dec 2020
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
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Moesges, Prof. Dr., Principal investigator, ClinCompetence GmbH, Genter Str. 7, 50672 Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203810
- Sponsor's protocol ID
- btph-044-2019-ERS09
- Status last verified
- Jul 2020
- First submitted
- 17 Dec 2019
- Last updated
- 20 Oct 2026
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) Compared to Saline Spray in Patients Suffering From Sore Throat Due to Acute Pharyngitis and Dry Cough
- ClinicalTrials.gov ID
- NCT04203810
- Acronym / sponsor ID
- btph-044-2019-ERS09
- Conditions
- Sore Throat, Acute Pharyngitis, Cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 18 Dec 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 aim of this multicentre, actively controlled, randomized, open label, parallel group, prospective, comparator study is to collect data on the clinical effectiveness and tolerability of the medical device ERS09 compared to a well-established comparator spray in the symptomatic treatment of sore throat due to acute pharyngitis and dry cough.
Detailed description
The aim of this study is to collect data on the clinical effectiveness and tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) compared to the well-established comparator spray EMSER® Hals- und Rachenspray (both medical devices) in the symptomatic treatment of sore throat due to acute pharyngitis and dry cough.
The principle mode of action of ectoine is based on the physical interaction of the compatible solute with water and the resulting stabilizing effects of the ectoine hydro complex on the epithelial tissue treated. Althaea has so-called mucilaginous effects, that means generally a shielding of the irritated mucus membranes by thin polysaccharide layers. Such mucilaginous polymer layers lead to rehydration, coating of peripheral sensory receptors, and therefore to a reduction of throat irritation and dry coughing. Honey acts predominantly as demulcent with its viscous liquid constitution based on mainly fructose and glucose. The combination of all three substances may result in a multi-modal treatment of the symptoms of sore throat and dry cough.
Patients will be randomly assigned to one of the following treatment groups:
- treatment with ERS09
- treatment with comparator (EMSER® Hals- und Rachenspray)
Patients' symptoms will be documented by the physician in investigator questionnaires at visits 1, 2 and 3. At visit 1 the patients will receive a patient diary for daily documentation of their symptoms. In addition, patients and investigators will be asked to evaluate the overall effectiveness and tolerability of ERS09 spray at visit 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ectoin® Mouth and Throat Spray Althaea Honey | Experimental | Device: Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)4 puffs to be administered as needed several times a day for patients aged ≥ 12 years. A maximum of 10 applications per day should not be exceeded. |
| EMSER® Hals- und Rachenspray (throat spray) | Active comparator | Device: EMSER® Hals-und Rachenspray (throat spray)1 to 3 puffs to be administered several times a day |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP)/ISO14155 guidelines and local regulation prior to participation in the trial
- Individuals regardless of gender 12 years old or older
- Patients with sore throat due to acute pharyngitis and dry cough, both with an onset of symptoms no more than 72 hours prior to Visit 1
- Sore Throat Pain Intensity Score ≥ 40 mm (measured on a 100 mm visual analogue scale [VAS])
Key exclusion criteria (9 listed)
- Hypersensitivity to Ectoin, Althaea off., Honey or any of the other ingredients of the ERS09 or the comparator
- Fructose intolerance or glucose-galactose malabsorption
- Pregnant or breast-feeding women
- Suspected bacterial pharyngitis
- Individuals younger than 12 years
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® Mouth and Throat Spray Althaea Honey (ERS09)4 puffs to be administered as needed several times a day for patients aged ≥ 12 years. A maximum of 10 applications per day should not be exceeded. | Device | Ectoin® Mouth and Throat Spray Althaea Honey |
| EMSER® Hals-und Rachenspray (throat spray)1 to 3 puffs to be administered several times a day | Device | EMSER® Hals- und Rachenspray (throat spray) |
Primary outcome
Change of mean total symptom score
Time frame: 7 days
Baseline adjusted mean change of patient's assessment of total symptom score (patient diary) averaged over 7 treatment days
Change of daily symptom score
Time frame: 1 day
Baseline adjusted daily change of patient's assessment of total symptom score (patient diary)
1 secondary outcome
Adverse events (AE) and serious adverse events (SAE) during treatment phase
Time frame: 7 +/- 2 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 20 Oct 2026.
- 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.
Ralph Moesges, Prof. Dr. principal investigator
ClinCompetence GmbH, Genter Str. 7, 50672 Cologne, Germany
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) and EMSER® Hals-und Rachenspray (throat spray) in people with Sore Throat and Acute Pharyngitis, run by Bitop AG at 12 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 4 inclusion and 9 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 12 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?
Change of mean total symptom score (time frame: 7 days). The study lists 2 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.