Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)
Primary Purpose
Sore Throat, Acute Pharyngitis, Cough
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)
EMSER® Hals-und Rachenspray (throat spray)
Sponsored by
About this trial
This is an interventional treatment trial for Sore Throat
Eligibility Criteria
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)
Sites / Locations
- Dr. Pasch
- Dr. Sondermann
- Dr. Männer
- Dr. Kienle-Gogolok
- Dr. Ginko
- Praxis für Hals-Nasen-Ohren-Heilkunde
- Dr. Thieme
- Dr. Horn
- Dr. Lenzenhuber
- Dr. Vent
- Dr. Konzelmann
- Reiber
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ectoin® Mouth and Throat Spray Althaea Honey
EMSER® Hals- und Rachenspray (throat spray)
Arm Description
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.
1 to 3 puffs to be administered several times a day
Outcomes
Primary Outcome Measures
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
Change of daily symptom score
Baseline adjusted daily change of patient's assessment of total symptom score (patient diary)
Secondary Outcome Measures
Adverse events (AE) and serious adverse events (SAE) during treatment phase
Evaluation of severity, nature and frequency of AEs/SAEs and their relationship to the investigational devices
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04203810
Brief Title
Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
December 4, 2020 (Actual)
Study Completion Date
December 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bitop AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat, Acute Pharyngitis, Cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ectoin® Mouth and Throat Spray Althaea Honey
Arm Type
Experimental
Arm Description
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.
Arm Title
EMSER® Hals- und Rachenspray (throat spray)
Arm Type
Active Comparator
Arm Description
1 to 3 puffs to be administered several times a day
Intervention Type
Device
Intervention Name(s)
Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)
Intervention Description
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
Intervention Name(s)
EMSER® Hals-und Rachenspray (throat spray)
Intervention Description
1 to 3 puffs to be administered several times a day
Primary Outcome Measure Information:
Title
Change of mean total symptom score
Description
Baseline adjusted mean change of patient's assessment of total symptom score (patient diary) averaged over 7 treatment days
Time Frame
7 days
Title
Change of daily symptom score
Description
Baseline adjusted daily change of patient's assessment of total symptom score (patient diary)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Adverse events (AE) and serious adverse events (SAE) during treatment phase
Description
Evaluation of severity, nature and frequency of AEs/SAEs and their relationship to the investigational devices
Time Frame
7 +/- 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Moesges, Prof. Dr.
Organizational Affiliation
ClinCompetence GmbH, Genter Str. 7, 50672 Cologne, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Pasch
City
Aachen
Country
Germany
Facility Name
Dr. Sondermann
City
Aachen
Country
Germany
Facility Name
Dr. Männer
City
Arnsberg
Country
Germany
Facility Name
Dr. Kienle-Gogolok
City
Bad Schönborn
Country
Germany
Facility Name
Dr. Ginko
City
Bonn
Country
Germany
Facility Name
Praxis für Hals-Nasen-Ohren-Heilkunde
City
Dresden
Country
Germany
Facility Name
Dr. Thieme
City
Duisburg
Country
Germany
Facility Name
Dr. Horn
City
Heidelberg
Country
Germany
Facility Name
Dr. Lenzenhuber
City
Jülich
Country
Germany
Facility Name
Dr. Vent
City
Köln
Country
Germany
Facility Name
Dr. Konzelmann
City
Röthenbach
Country
Germany
Facility Name
Reiber
City
Schorndorf
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)
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