Allergic rhinitis or rhinojunctivitis, with or without seasonal asthma to more than one of the following pollens: Grasses, Olea europaea and Parietaria judaica. MedDRA version: 15.0 Level: LLT Classification code 10036019 Term: Pollen allergy System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Depigmented and polymerized allergen extract of 50% Grasses/50% Olea europaea
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Depigmented and polymerized allergen extr
Sponsors
Laboratorios LETI, S.L.U
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subject has dated and signed the informed consent. -Men and women between 18 and 60 years of age (both inclusive). -Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year, with or without allergic seasonal asthma caused by a clinically relevant sensitization to pollens (grasses AND P. judaica or O. europaea). Asthmatic patients can be included in the trial only if seasonal asthma is controlled with a medium daily dose minor or equal to 800 µg/day of budesonide or an equivalent or minor or equal to 400 µg/day of budesonide or an equivalent plus a long-acting-?2 agonist. - Asthmatic patients must be stable within 3 months prior to Visit 1 and on an stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study. FEV1 must be ? 80% of predicted value. -The IgE-mediated sensitization must be demonstrated by the following: medical history AND IgE specific CAP RAST ? 2 to the suspected relevant pollens (grass pollen AND Olea and/or Parietaria) AND a positive skin prick test to grass and Olea and/or Parietaria. A skin prick test will be considered positive when it produces a wheal of at least 3 mm according to the largest diameter. 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 54 F.1.3 Elderly (>=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 800 µg/day of Budesonide or an equilent, without long-lasting beta-2 agonists or requiring a dose > of 400 µg/day of Budesonide or an equivalent plus a long-acting-?2 agonist to reach asthma 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 (for example, emphysema or bronchiectasis). -Immune system diseases, both autoimmune diseases and immunodeficiency. -Any disease involving a contraindication for the use of adrenaline (for example, hyperthyroidism). -Serious uncontrolled diseases involving a risk for the subjects participating in this study, including the following for example: heart failure, serious or uncontrolled respiratory diseases, endocrine diseases, clinically relevant liver or kidney diseases or hematological diseases. -Malignant disease with activity in the last 5 years. -Excessive consumption of alcohol, drugs or medication. -Serious psychiatric, psychological or neurological disorders. -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 tricyclic, tetracyclic and IMAO antidepressants. It will not be allowed to wash up antidepressants to enter the study because of the risks of interrupting antidepressant treatment, so patients on antidepressants therapy cannot be included in the trial. -Use of systemic corticosteroids 3 months before visit 1. -Immunization with prophylactic (bacterial or viral) vaccines within 7 days before visit 1 (prophylactic vaccines are allowed during the administration of IMP period provided they are administered at least one week after IMP administration and the next IMP administration is administered at least 14 days later). -Participation of the subject in another clinical trial 30 days before visit 2 -Subjects who are going to donate stem cells, blood, organs or bone marrow in the course of the study. -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. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. -No written informed consent upon enrolment. -Subjects who are unable to comply with the requirements of the study or who in the opinion of t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later. The treatment period consists, thus, of 4 weeks. Primary variable: ?Number of subjects [%] suffering at least one immediate or delayed systemic reaction of grade 2 or higher during the 4-weeks treatment period [grading according to the 2006 EAACI standards;;Secondary Objective: Secondary variables (safety): ?Number of subjects [%] suffering immediate or delayed systemic reactions broken down by grade (EAACI classification). ?Number of subjects [%] suffering immediate or delayed local reactions broken down by diameter ( 10 cm). ?Number of immediate or delayed systemic reactions broken down by grade (EAACI classification). ?Number of immediate or delayed local reactions broken down by diameter ( 10 cm). -(Immunology assessment): Measurement of the following immunological parameters: sIgE and sIgG4 at baseline and at the end of the study (after two maintenance doses).;Primary end point(s): The primary variable in this study is the number of subjects [%] who experienced at least one immediate or delayed systemic reaction of grade 2 or higher during the treatment period.;Timepoint(s) of evaluation of this end point: Safety: Local and systemic adverse reactions (EAACI classification) within 24h after treatment. it must be possible to conduct an extra phone call 48 h after IMP administration provided delayed reactions have occurred within 24 h after IMP administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary variables, which will be analyzed descriptively, are the ?Number of subjects [%] suffering immediate and/or delayed systemic reactions broken down by grade (EAACI classification). ?Number of subjects [%] suffering immediate and/or delayed local reactions broken down by diameter ( 10 cm). ?Number of immediate and/or delayed systemic reactions broken down by grade (EAACI classification). ?Number of immediate and/or delayed local reactions broken down by diameter ( 10 cm). ?(Immunology assessment):Measurement of the following immunological parameters: sIgE and sIgG4 at baseline and at the end of the study (after two maintenance doses).;Timepoint(s) of evaluation of this end point: Safety: Local and systemic adverse reactions (EAACI classification) within 24h and 48h after treatment. Inmunological response: at screening and 1 week after the end of the treatment ( follow-up visit) | — |
Countries
Spain
Contacts
Public ContactDepartamento Médico
Laboratorios LETI, S.L.U
Outcome results
None listed