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

Bitop

Status

Completed

Conditions

Acute Pharyngitis

Cough

Sore Throat

Treatments

Device: Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)

Device: EMSER® Hals-und Rachenspray (throat spray)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04203810

btph-044-2019-ERS09

Details and patient eligibility

About

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.

Full 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.

Enrollment

194 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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)