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COMPLETED
NCT04203810
NA

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

Sponsor: Bitop AG

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

194

Start Date

2020-01-14

Completion Date

2020-12-04

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

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

Locations (12)

Dr. Pasch

Aachen, Germany

Dr. Sondermann

Aachen, Germany

Dr. Männer

Arnsberg, Germany

Dr. Kienle-Gogolok

Bad Schönborn, Germany

Dr. Ginko

Bonn, Germany

Dr. Vent

Cologne, Germany

Praxis für Hals-Nasen-Ohren-Heilkunde

Dresden, Germany

Dr. Thieme

Duisburg, Germany

Dr. Horn

Heidelberg, Germany

Dr. Lenzenhuber

Jülich, Germany

Dr. Konzelmann

Röthenbach, Germany

Reiber

Schorndorf, Germany