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

NCT04203810 | Completed

• 1 other identifier: btph-044-2019-ERS09
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Sore Throat; Acute Pharyngitis; Cough

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adverse events (AE) and serious adverse events (SAE) during treatment phase

  7 +/- 2 days

Study Arms (2)

Ectoin® Mouth and Throat Spray Althaea Honey

EXPERIMENTAL

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)

EMSER® Hals- und Rachenspray (throat spray)

ACTIVE COMPARATOR

1 to 3 puffs to be administered several times a day

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

Interventions

Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) 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.

Ectoin® Mouth and Throat Spray Althaea Honey

EMSER® Hals-und Rachenspray (throat spray) DEVICE

1 to 3 puffs to be administered several times a day

EMSER® Hals- und Rachenspray (throat spray)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[VAS\])

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (12)

Dr. Pasch

Aachen, Germany

Location

Dr. Sondermann

Aachen, Germany

Location

Dr. Männer

Arnsberg, Germany

Location

Dr. Kienle-Gogolok

Bad Schönborn, Germany

Location

Dr. Ginko

Bonn, Germany

Location

Dr. Vent

Cologne, Germany

Location

Praxis für Hals-Nasen-Ohren-Heilkunde

Dresden, Germany

Location

Dr. Thieme

Duisburg, Germany

Location

Dr. Horn

Heidelberg, Germany

Location

Dr. Lenzenhuber

Jülich, Germany

Location

Dr. Konzelmann

Röthenbach, Germany

Location

Reiber

Schorndorf, Germany

Location

MeSH Terms

Conditions

Pharyngitis; Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ralph Moesges, Prof. Dr.

  ClinCompetence GmbH, Genter Str. 7, 50672 Cologne, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 18, 2019
• Study Start: January 14, 2020
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: July 28, 2022

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12)