Validation of Combined Symptom Medication Score (cSMS) in Allergic Patients

Completed

• Conditions: Allergic Asthma; Allergic Rhinoconjunctivitis
• Interventions: Biological: Immunotherapy

• Registration Number: NCT03850626
• Lead Sponsor: Leti Pharma GmbH

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.

Detailed Description

Approximately 20% of the general public suffer from seasonal or perennial allergic rhinoconjunctivitis. The only available curative therapy is AIT. The effectiveness of AIT was demonstrated in numerous randomized clinical trials but comparability is difficult because of different primary and secondary endpoints.

To validate the CSMS, adolescent (≥ 12 years) and adult patients will be observed who are allergic to house dust mites (HDM), tree or grass pollen and who were treated with Depigoid. Depigoid is a registered (for tree and grass pollen) respective authorized (for HDM) suspension for injection for the treatment of immediate type allergic diseases. Depigoid contains depigmented and chemically modified allergen extracts, so called allergoids, derived from grass pollen, tree pollen or HDM.

Allergy symptoms will be documented over a time period of two years: Either for two consecutive allergy seasons (for tree and grass pollen allergic patients) or for two consecutive exposure periods (September-December) for HDM allergic patients. The symptoms (4 nasal and 2 ocular symptoms) and allergy medication intake will be documented on a daily basis either using the CSMS questionnaire or the especially developed electronic CSMS+ diary application.

Already validated and established questionnaires will be used to validate the CSMS with regard to Quality of Life (QoL) and symptom control: the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Adolescent RQLQ (AdolRQLQ, for patients aged 12-17 years), Asthma Quality of Life Questionnaire (AQLQ) and AQLQ for patients aged 12 years and older (AQLQ+12), the Asthma Control Test (ACT), Rhinitis Control Assessment Test (RCAT) and the Visual Analogue Scale (VAS).

Study Timeline

• Study Start: 2018-09-09
• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-22
• Primary Completion: 2020-09-03
• Study Completion: 2020-09-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Indication of an allergen-specific immunotherapy with Depigoid

Exclusion Criteria

• exclusion criteria according to the SmPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immunotherapy Grass	Immunotherapy	Patients allergic to grass pollen
Immunotherapy Trees	Immunotherapy	Patients allergic to tree pollen
Immunotherapy Mites	Immunotherapy	Patients allergic to HDM

Primary Outcome Measures

Name	Time	Method
cSMS	after up to 60 days during allergen exposure period (=pollen season resp. allergen season) in 2 consecutive years	Combined Symptom and Medication Score

Trial Locations

Locations (1)

Dr. med Andrea Kienle-Gogolok; 🇩🇪 Bad Schönborn, Germany