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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2020-12-04

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.

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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.

Conditions

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Sore Throat Acute Pharyngitis Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ectoin® Mouth and Throat Spray Althaea Honey

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.

Group Type EXPERIMENTAL

Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)

Intervention Type 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)

1 to 3 puffs to be administered several times a day

Group Type ACTIVE_COMPARATOR

EMSER® Hals-und Rachenspray (throat spray)

Intervention Type DEVICE

1 to 3 puffs to be administered several times a day

Interventions

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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.

Intervention Type DEVICE

EMSER® Hals-und Rachenspray (throat spray)

1 to 3 puffs to be administered several times a day

Intervention Type DEVICE

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)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No