NCT04203810

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Bitop AG · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Sore Throat
• Acute Pharyngitis
• Cough

Interventions

Type	Name	Description
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.
DEVICE	EMSER® Hals-und Rachenspray (throat spray)	1 to 3 puffs to be administered several times a day

Timeline

• Start date: 2020-01-14
• Primary completion: 2020-12-04
• Completion: 2020-12-04
• First posted: 2019-12-18
• Last updated: 2022-07-28

Locations

12 sites across 1 country: Germany