NCT03850626

Brief Summary

The CSMS was defined by the European Academy of Allergy and Immunology Taskforce as a standardised tool to assess clinical effects of allergen-specific immunotherapy (AIT). The aim of this study is to validate the CSMS as a tool to assess the clinical effects of Depigoid AIT, so that the CSMS can be used in future studies as a primary endpoint as well as a comparative parameter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 9, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2020

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

February 18, 2019

Last Update Submit

March 25, 2021

Conditions

Allergic RhinoconjunctivitisAllergic Asthma

Keywords

AllergyRhinoconjuctivitisCombined Symptom and Medication ScoreAllergic AsthmaPollenMites

Outcome Measures

Primary Outcomes (1)

  • cSMS

    Combined Symptom and Medication Score

    after up to 60 days during allergen exposure period (=pollen season resp. allergen season) in 2 consecutive years

Study Arms (3)

Immunotherapy Trees

Patients allergic to tree pollen

Biological: Immunotherapy

Immunotherapy Grass

Patients allergic to grass pollen

Biological: Immunotherapy

Immunotherapy Mites

Patients allergic to HDM

Biological: Immunotherapy

Interventions

ImmunotherapyBIOLOGICAL

subcutaneous injection

Immunotherapy GrassImmunotherapy MitesImmunotherapy Trees

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adults and adolescents suffering from allergic diseases (rhinitis, rhinoconjunctivitis, with or without concomitant asthma)

You may qualify if:

  • \- Indication of an allergen-specific immunotherapy with Depigoid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. med Andrea Kienle-Gogolok

Bad Schönborn, 76869, Germany

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Angelika Sager, Dr.med.

    Medical Department

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 22, 2019

Study Start

September 9, 2018

Primary Completion

September 3, 2020

Study Completion

September 3, 2020

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)