Clinical study to assess the efficacy and safety of sublingual allergen immunotherapy spray in patients suffering from house dust mite allergy
- Conditions
- Patients with house dust mites related allergic rhinitis/rhinoconjunctivitis and well-controlled mild-to-moderate or without asthmaMedDRA version: 20.0Level: PTClassification code 10010744Term: Conjunctivitis allergicSystem Organ Class: 10015919 - Eye disordersMedDRA version: 21.1Level: PTClassification code 10039085Term: Rhinitis allergicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 21.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-005169-41-DE
- Lead Sponsor
- ROXALL Medizin GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 996
•Patients who signed and dated informed consent form obtained prior to any study specific examination
•Female or male patients between 18 and 65 years of age at the time of signing the informed consent form
•Patients with moderate-to-severe allergic rhinitis / rhino-conjunctivitis due to house dust mites (HDM) for at least one year according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline
•Patients with well controlled mild-to-moderate or without asthma defined in GINA guideline (Global Initiative for Asthma, 2022)
•Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients)
•Sensitization to Dermatophagoides pteronyssinus, verified by :
- positive skin prick test (wheal diameter = 3 mm and negative control < 2 mm and positive (histamine) control = 3 mm) and
-Serum allergen-specific IgE to D. pteronyssinus = 0.7 kU/L (CAP EAST class = 2) and
-a Retrospective Rhinitis Total Symptom Score (RRTSS) = 2 (0-3 scale) based on the most severe days during winter preceding enrolment and
?positive response to nasal provocation with D. pteronyssinus allergen extract (at least at the third concentration step)
•Assumed compliance and ability of the patient to understand the patient´s electronic diary and to follow the instructions of the study staff
•Compliance and ability of the patient to complete an electronic diary for self-evaluation of the symptoms and rescue medication
•Safety laboratory results within the normal range or considered to be not clinically significant in any other case
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 996
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Previous immunotherapy with allergen extract of house dust mites (HDM) according to the homologous group of the Dermatophagoides genus, as defined in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831) within the last 5 years
•Patients with co-sensitizations or co-allergies to any perennial or seasonal allergen (with exception of D. farinae), which interfere with the conduct of the study (e. g. with the tNPT), especially if the result in SPT for this allergen is higher than that for D. pteronyssinus
•Patients with co-sensitizations to any perennial or seasonal allergen with overlapping during PMP but which are not cross-reactive with D. pteronyssinus and with specific IgE levels
= class 2 CAP/PHADIA
•Simultaneous participation in other clinical trials
•Simultaneous specific immunotherapy with other allergens
•Participation in a clinical trial in the last three months before enrolment
•Contraindications for SLIT (Pitsios et al., 2015)
•Contraindications for SPT
•Contraindications for NPT
•Serious systemic reactions to allergen-specific immunotherapy in the past
•Hypersensitivity to excipients of the IMP
•Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD
•Severe, or partly controlled or uncontrolled asthma according to GINA guideline
(Global Initiative for Asthma, 2022)
•Asthmatic patients with FEV1 = 70 % of predicted normal value at screening
•Chronic or severe acute diseases of nose or eyes
•Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis)
•Therapy with immunoglobulins
•Completed or ongoing treatment with anti-IgE-antibody
•Diseases of the immune system including autoimmune and immune deficiencies (with exception to well-controlled Hashimoto thyroiditis and type-1 diabetes mellitus)
•Severe acute or chronic inflammatory or infectious diseases
•Chronic or acute diseases of the heart, kidney or liver with severe impairment of their function
•Malignancy within the previous 5 years
•Active chronic urticaria
•Active severe atopic eczema
•Alcohol, drug, or medication abuse within the past year and/or during the study
•Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with childbearing potential or a positive pregnancy test at screening
•Use of non-allowed medication
•Severe psychiatric, psychological, or neurological disorders; completed or ongoing long-term treatment with tranquilizer or psychoactive drugs (including tricyclic anti-depressants)
•Relationship or dependence with the sponsor and/or investigator
•Legal incapacity
•Patients who are jurisdictional or governmentally institutionalized
•Risk of non-compliance by the patient with the study procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this trial is to establish the most effective and best-tolerated dose of SULGEN® Spray D. pteronyssinus in terms of benefit-risk balance and CSMS (Combined Symptom and Medication Score).<br>;Secondary Objective: The secondary objective of the study is to support the evaluation of the efficacy of each dose treatment with SULGEN® Spray D. pteronyssinus compared to the placebo.;Primary end point(s): Primary efficacy endpoint <br>The primary (efficacy) endpoint is defined as the absolute differences in mean CSMS (Combined Symptom and Medication Score) during the PMP of each active treatment group compared to the placebo treatment group.<br>The CSMS is the EAACI-recommended end point for pivotal studies, described in detail in a Position Paper. Briefly, CSMS is the sum of the daily symptom score (dSS) plus daily medication score (dMS). <br>;Timepoint(s) of evaluation of this end point: 15.04.2023 - 10.06.2025
- Secondary Outcome Measures
Name Time Method