Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03850626
Other study ID # cSMS-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 9, 2018
Est. completion date September 3, 2020

Study information

Verified date March 2021
Source Leti Pharma GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date September 3, 2020
Est. primary completion date September 3, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Indication of an allergen-specific immunotherapy with Depigoid Exclusion Criteria: - exclusion criteria according to the SmPC

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Immunotherapy
subcutaneous injection

Locations

Country Name City State
Germany Dr. med Andrea Kienle-Gogolok Bad Schönborn

Sponsors (1)

Lead Sponsor Collaborator
Leti Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary cSMS Combined Symptom and Medication Score after up to 60 days during allergen exposure period (=pollen season resp. allergen season) in 2 consecutive years
See also
  Status Clinical Trial Phase
Completed NCT02911688 - Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure Phase 2
Active, not recruiting NCT01776177 - The REALITY Study - a Real-life Long-term Analysis of Xolair Therapy N/A
Completed NCT00485576 - Safety and Efficacy Study of Eculizumab in Patients With Mild Allergic Asthma Phase 2
Completed NCT00736801 - Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma N/A
Completed NCT00515775 - Influence of a Inhaled Corticosteroid Therapy Versus Corticosteroid + LABA Therapy on the FeNO of Asthmatic Children N/A
Completed NCT04259164 - Anti-inflammatory Effects Glycopyrronium Phase 3
Active, not recruiting NCT04619017 - Airway Immune Response to Allergens (Use Lay Language Here) Phase 1
Completed NCT01699594 - Change in Airway Responsiveness After Allergen Exposure N/A
Completed NCT00999466 - The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen Phase 2
Completed NCT01353755 - 2nd Pivotal Study rPhleum - Adults and Adolescents With Rhinoconjunctivitis +/-Controlled Asthma Phase 3
Completed NCT00434434 - A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma Phase 2
Completed NCT00492076 - Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma Phase 4
Completed NCT00490425 - Prevention of Asthma and Allergy by Probiotic Lactobacillus GG Phase 4
Completed NCT00829179 - Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma Phase 3
Recruiting NCT04542902 - Non-coding RNAs Analysis of Eosinophil Subtypes in Asthma N/A
Recruiting NCT04109534 - Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma N/A
Active, not recruiting NCT05186025 - Tyrosine Allergoid Paediatric and Adult Study
Withdrawn NCT03307278 - House Dust Mite Induced Inflammasome Activation on Corticosteroid Resistance N/A
Enrolling by invitation NCT06151938 - Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis
Withdrawn NCT04401631 - Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation