Validation of Combined Symptom Medication Score (cSMS) in Allergic Patients
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|ClinicalTrials.gov Identifier: NCT03850626|
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : February 25, 2019
|Condition or disease||Intervention/treatment|
|Allergic Rhinoconjunctivitis Allergic Asthma||Biological: Immunotherapy|
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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
Patients allergic to tree pollen
Patients allergic to grass pollen
Patients allergic to HDM
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03850626
|Contact: Thomas Mueller, Dr.rer.nat.||+4989121400 ext email@example.com|
|Contact: Eva-Cornelia Ticinelli||+49230220286 ext firstname.lastname@example.org|
|Dr. med Andrea Kienle-Gogolok||Recruiting|
|Bad Schönborn, Germany, 76869|
|Contact: Andrea Kienle-Gogolok, Dr. med.|
|Study Director:||Angelika Sager, Dr.med.||Medical Department|