Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sore Throat, Acute Pharyngitis, Cough

Intervention / Treatment
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* Device: Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)
* Device: EMSER® Hals-und Rachenspray (throat spray)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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]) Exclusion Criteria: 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 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)

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ectoin® Mouth and Throat Spray Althaea Honey<br>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 (ERS09)<br>* 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.<br>|
| Active Comparator: EMSER® Hals- und Rachenspray (throat spray)<br>1 to 3 puffs to be administered several times a day | Device: EMSER® Hals-und Rachenspray (throat spray)<br>* 1 to 3 puffs to be administered several times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 days | 
| Change of daily symptom score | Baseline adjusted daily change of patient's assessment of total symptom score (patient diary) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 +/- 2 days |