CLINICAL TRIAL TO ASSESS THE TOLERABILITY, SAFETY AND EFFICACY OF SUBLINGUAL IMMUNOTHERAPY IN PATIENTS SUFFERING FROM HOUSE DUST MITE ALLERGY
- Conditions
- Patients with house dust mites related allergic rhinitis/rhino-conjunctivitis (with or without well controlled asthma).Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-002321-22-ES
- Lead Sponsor
- Roxall Medicina España S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 165
•Patients who signed and dated the patients' 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 for at least one year according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline.
•Patients with or without well controlled mild-to-moderate asthma according to GINA guideline (Global Initiative for Asthma, 2017).
•Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients)
•Sensitization to Dermatophagoides pteronyssinus, verified by:
a)positive skin prick test (wheal diameter = 3 mm and negative control < 2 mm and positive (histamine) control = 3 mm) and,
b)serum allergen-specific IgE to D. pteronyssinus = 0.7 kU/L (CAP EAST class = 2) and,
c) positive response to nasal provocation with D. pteronyssinus allergen extract (at least at the fourth concentration step)
•Assumed compliance and ability of the patient to understand the patients´ diary and to follow the instructions of the study staff.
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 165
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 co-sensitized to any pollen with clinical manifestations or co-allergies, whose allergic symptoms interfere with the conduct of the study (e. g. with the tNPT)
•Allergy against other perennial allergens like animal epithelia
•Patients co-sensitized to Lepidoglyphus destructor (LD), with IgE levels against LD higher than the double of the IgE levels against D. pteronyssinus
•Simultaneous participation in other clinical trials
•Simultaneous specific immunotherapy with other allergens
•Participation in a clinical trial in the last three months before enrolment
•Asthmatic patients with forced expiratory volume (FEV1) = 70 % of predicted normal value
•Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2017)
•Severe acute or chronic inflammatory or infectious diseases
•Inflammations or lesions within the oral cavity (e. g. gingivitis) as well as gastroenteritis at randomization
•Diseases of the immune system such as autoimmune and immune deficiencies (with exception to well controlled Hashimoto thyroiditis and type-1 diabetes mellitus)
•Immunosuppressive therapy within 3 months prior screening
•Chronic or acute diseases of the heart, kidney or liver with severe impairment of their function
•Hypersensitivity to excipients of the IMP
•Any severe or unstable lung disease (e. g. active tuberculosis, cystic fibrosis, COPD)
•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
•Malignancy within the previous 5 years
•Alcohol, drug, or medication abuse within the past year and/or during the study
•Use of non-allowed medication (see section 8.3.1)
•Contraindications for SPT
•Contraindication for NPT
•Patients with PNIF decrease = 20 % during tNPT after application of control solution at V0
•Relationship or dependence with the sponsor and/or investigator
•Legal incapacity
•Patients who are jurisdictional or governmentally institutionalized
•Serious systemic reactions to allergen-specific immunotherapy in the past
•Active chronic urticaria
•Active severe atopic eczema
•Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with child-bearing potential or a positive pregnancy test at screening
•Severe psychiatric, psychological, or neurological disorders; completed or ongoing long-term treatment with tranquilizers or psychactive drugs (including tricyclic antidepressants)
•Risk of non-compliance by the patient with study procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method