Allergic rhinitis or rhinoconjunctivitis with or without mild persistent or intermittent asthma, to Dermatophagoides pteronyssinus or Dermatophagoides pteronyssinus and Dermatophagoides farinae. MedDRA version: 14.1 Level: LLT Classification code 10020419 Term: House dust mite allergy System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Depigmented and polymerized allergen extract of D.pteronyssinus 100%
Product Code: 186
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Depigmented and polimerized allerg
Sponsors
Laboratorios LETI, S.L.U.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Men and women between 18 and 55 years of age (both inclusive). (2) Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year -- with or without symptoms of mild persistent or intermittent allergic asthma which is controlled with a dose =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any contraindication for treatment with allergen specific immunotherapy - Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value 400 µg/day of Budesonide or an equivalent, without long-lasting beta-2 agonists, to reach control according to the Global Initiative for Asthma (GINA 2010) - Patients with non controlled bronchial asthma within 3 months prior to Visit 1 - Patients with asthma who have been treated with systemic steroids within 3 months prior to V1 - Patients with hospital admission due to asthma exacerbations within 1 year prior to V1 - Acute or chronic inflammatory or infectious diseases of the airways - Chronic structural diseases of the respiratory system - Immune system diseases, both autoimmune diseases and immunodeficiency - Any disease involving a contraindication for the use of adrenaline - Serious uncontrolled diseases - Malignant disease with activity in the last 5 years - Use of immunotherapy with allergenic extracts of storage or house dust mites in the last 5 years - Systemic or topical treatment with beta-blocker drugs 1 week before visit 2 - Treatment with substances interfering with the immune system 2 weeks before visit 2 - Use of psychotropic or antidepressants substances 1 week before visit 2 - Use of systemic corticosteroids 3 months before visit 1 - Immunization with prophylactic (bacterial or viral) vaccines within 7 days before visit 2 - Female subjects who are pregnant or nursing and women with a positive pregnancy test at visit 1 or 2 - Women of childbearing potential not using highly effective methods of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of a 4-month treatment with an extract of Depigoid® Dermatophagoides pteronyssinus 100% or a mixture of 50% Dermatophagoides pteronyssinus and 50% Dermatophagoides farinae at a concentration of 500 DPP/ml administered following a rush build-up regimen.;Secondary Objective: To assess the subjects' immunologic responses to the above treatment;Primary end point(s): Safety: Local and systemic adverse reactions (EAACI classification); adverse events.;Timepoint(s) of evaluation of this end point: Safety: Reactions within 48h after treatment; Adverse events during study plus 1 week follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: Immunologic response measured by immunological parameters;Timepoint(s) of evaluation of this end point: Efficacy: At screening and 1 week after end of treatment (follow-up visit) | — |
Countries
Spain
Contacts
Public ContactElvira Lara
Harrison Clinical Research Iberica, SL
Outcome results
None listed