NCT03975257

Brief Summary

The goal of this multicentric, prospective, randomised, controlled study (§23b German Act on Medical Devices (MPG)) is to investigate the efficacy of Ectoin Lozenges (EHT02) in treatment and prevention of oropharyngeal allergic symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2019

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

7 months

First QC Date

January 22, 2019

Last Update Submit

December 9, 2019

Conditions

Allergy

Outcome Measures

Primary Outcomes (3)

  • cumulative score of allergic symptoms of the lips evaluated by the patient

    about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the lips (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)

    about 30 minutes after SLIT-initiation

  • cumulative score of allergic symptoms of the mouth evaluated by the patient

    about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the mouth (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)

    about 30 minutes after SLIT-initiation

  • cumulative score of allergic symptoms of the throat evaluated by the patient

    about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the throat (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)

    about 30 minutes after SLIT-initiation

Secondary Outcomes (1)

  • Incidence of adverse events/serious adverse events

    through study visit (participation encompasses 1 visit of approx. 60 min duration)

Study Arms (3)

Preventive application of EHT02

EXPERIMENTAL

application of one Ectoin Lozenge before SLIT-initiation

Device: Medical Device: Ectoin Lozenge

Therapeutic application of EHT02

EXPERIMENTAL

application of one Ectoine Lozenge after SLIT-initiation

Device: Medical Device: Ectoin Lozenge

No application of EHT02

NO INTERVENTION

SLIT-Initiation without Ectoin Lozenge

Interventions

Medical Device: Ectoin LozengeDEVICE

Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use

Also known as: EHT02
Preventive application of EHT02Therapeutic application of EHT02

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • initiation of a SLIT
  • minimum age of 18 years
  • written consent of the patient

You may not qualify if:

  • Surgical Procedures in the mouth and throat region prior to the study
  • patients with known intolerance to one of the substances used
  • pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Facharzt f. HNO-Heilkunde

Aachen, Germany

Location

Fachärztin für Hals-Nasen-Ohrenheilkunde

Bad Schönborn, Germany

Location

Facharzt f. Dermatologie ruhrDerm GbR

Bochum, 44803, Germany

Location

Facharzt für Lungen- und Bronchialheilkunde

Bonn, 53119, Germany

Location

Facharzt für Haut und Geschlechtskrankheiten

Gelsenkirchen, Germany

Location

Arzt für Hals-Nasen-Ohrenheilkunde, Allergologie, Umweltmedizin, Naturheilverfahren, Flugmedizin, Taucherarzt (GTÜM)

Heidelberg, Germany

Location

Fachärztin f. HNO-Heilkunde, Allergologie

Jülich, 52428, Germany

Location

Facharzt für Hals-Nasen-Ohrenheilkunde, Allergo GmbH Stuttgart, Klinische Prüfstelle Schorndorf

Schorndorf, Germany

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Andreas Bilstein, Dr.

    CSO

    STUDY DIRECTOR

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

January 22, 2019

First Posted

June 5, 2019

Study Start

February 4, 2019

Primary Completion

September 12, 2019

Study Completion

September 12, 2019

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations

DE(8)