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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03850626
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : February 25, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Allergic Rhinoconjunctivitis Allergic Asthma Biological: Immunotherapy

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).

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validierung Des cSMS in Patienten Mit Allergischer Rhinokonjunktivitis (Baum- Und Gräserpollen, Hausstaubmilben). - Eine NIS Bei Patienten, Die Depigoid® Als Spezifische Immuntherapie Erhalten
Actual Study Start Date : September 9, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Immunotherapy Trees
Patients allergic to tree pollen
Biological: Immunotherapy
subcutaneous injection

Immunotherapy Grass
Patients allergic to grass pollen
Biological: Immunotherapy
subcutaneous injection

Immunotherapy Mites
Patients allergic to HDM
Biological: Immunotherapy
subcutaneous injection

Primary Outcome Measures :
  1. cSMS [ Time Frame: after up to 60 days during allergen exposure period (=pollen season resp. allergen season) in 2 consecutive years ]
    Combined Symptom and Medication Score

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adults and adolescents suffering from allergic diseases (rhinitis, rhinoconjunctivitis, with or without concomitant asthma)

Inclusion Criteria:

- Indication of an allergen-specific immunotherapy with Depigoid

Exclusion Criteria:

- exclusion criteria according to the SmPC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03850626

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Contact: Thomas Mueller, Dr.rer.nat. +4989121400 ext 268
Contact: Eva-Cornelia Ticinelli +49230220286 ext 142

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Dr. med Andrea Kienle-Gogolok Recruiting
Bad Schönborn, Germany, 76869
Contact: Andrea Kienle-Gogolok, Dr. med.         
Sponsors and Collaborators
Leti Pharma GmbH
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Study Director: Angelika Sager, Medical Department

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Responsible Party: Leti Pharma GmbH Identifier: NCT03850626     History of Changes
Other Study ID Numbers: cSMS-2018
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Leti Pharma GmbH:
Combined Symptom and Medication Score
Allergic Asthma

Additional relevant MeSH terms:
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Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs