Allergic rhinitis or rihinoconjuntivitis, with controlled allergic asthma due to D. pteronyssinus and Blomia tropicalis or Lepidoglyphus destructor sensitization. MedDRA version: 17.0 Level: LLT Classification code 10020419 Term: House dust mite allergy System Organ Class: 100000004870
Conditions
Interventions
Product Name: DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Depigmented modified allergen extract of D. pteronyssinus
Sponsors
Laboratorios LETI S.L.U
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subject has provided appropriately signed and dated written informed consent. 2.Men and women aged ? 18 years and ? 70 years of age at Visit 1. 3.Has an FEV1 value ? 80% of predicted normal value at Visit 1. 4.Individuals suffering from perennial allergic rhinitis or rhinoconjunctivitis moderate-severe (see Annex 8 in order to verify the disease burden) for at least the preceding year, with controlled asthma, caused by double sensitization against Dermatophagoides pteronyssinus (DPT) and Lepidoglyphus destructor or Dermatophagoides pteronyssinus and Blomia tropicalis. ?The IgE-mediated sensitization must be verified by the following: o Suggestive medical history, and o Specific IgE to D. pteronyssinus and Lepidoglyphus destructor or D. pteronyssinus and Blomia tropicalis ? 0,7 KU/l (classe II). The IgE results are valid if performed within one year prior to V1, and o Positive skin prick test (SPT) to D. pteronyssinus and Lepidoglyphus destructor or Blomia tropicalis. A SPT will be considered positive when it produces a wheal whose diameter is at least 3 mm. The negative control must not develop a wheal or it must be smaller than the DPT one in 3 mm. - Asthmatic subjects can be included in the trial only if allergic asthma is controlled according to the Global Initiative for Asthma (GINA 2010) - Asthmatic subjects must be stable within 3 months prior to Visit 1 and on a stable inhaled steroid dose within 6 weeks prior to Visit 1 and throughout the study. 5.Patients sensitized to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelials cannot participate in the study if they are symptomatic. Patients sensitized to animal dander can participate only if they are not exposed. 6.If a female is of non-childbearing potential, the subject must be postmenopausal for at least 1 year or surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). 7.If a female is of childbearing potential, the subject must be non-lactating and non-pregnant (with a negative pregnancy test result at Visit 1) and must correctly use an effective method of contraception during the study. An effective method of contraception is defined as one that results in a failure rate of less than 1% per year. The following are allowed methods of contraception when used continuously and properly: hormonal contraceptives administered by implant, injection, or orally; complete abstinence; partner?s vasectomy if the female has not more than one partner. Barrier methods (e.g., preservatives) are only considered effective if used together with one of the above. 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 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1.Any contraindication for treatment with allergen specific immunotherapy. 2.Subjects with a previous history of anaphylaxis. 3.Patients with hospital admission due to asthma exacerbations within 1 year prior to V1. 4.Has uncontrolled asthma, according to Global Initiative for Asthma Guidelines (GINA 2010). 5.Acute or chronic infectious conjunctivitis. 6.Has acute or chronic inflammatory or infectious airways disease. 7.Has chronic structural diseases of the affected organ (e.g. eye, nose, lung). 8.History or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance. 9.Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism). 10.Has a severe uncontrolled disease that could increase the risk to the subjects while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders. 11.Subjects with chronic urticaria. 12.Subjects with moderate-severe atopic dermatitis (subjects with a SCORAD value >30 can not participate in the study). 13.Has had active malignant disease during the previous 5 years. 14.Has a significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient. 15.Has used immunotherapy with allergenic extracts of storage or house dust mites within the last 5 years or is receiving allergen specific immunotherapy with other allergens during the study period. 16.Has used systemic and/or topical treatment with beta-blocker drugs within 1 week prior to Visit 2 (first IMP administration). 17.Used psychotropic, tricyclic, tetracyclic and MAOI antidepressants within 1 month prior to Visit 1. It will not be allowed to perform a washout period of psychotropic or antidepressants to enter the study because of the risks of interrupting the treatment. 18.Used systemic corticosteroids within 3 months prior to Visit 1. 19.Treatment with substances interfering with the immune system 2 weeks before Visit 2 (first IMP administration). 20.Immunization with prophylactic (bacterial or viral) vaccines within 7 days prior to Visit 1 and within 7 days prior to visit 2 (first IMP administration). Prophylactic vaccines are allowed during the administration of IMP period provided they are administered at least one week after immunotherapy and the next immunotherapy dose is administered at least 14 days later. 21.Exposure to any investigational drug within one month or 6 half lives of the drug (whichever is longer). 22.Has abused alcohol, drugs or medications within the past year prior to Visit 1. 23.Lack of cooperation or compliance. 24.Donation of germ cells, blood, organs and/or bone marrow for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial is to evaluate the safety and tolerability of two allergens extract of mites mixes at 200 DPP/ml (DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis and DP/MG/14-2 Dermatophagoides pteronyssinus / Lepidoglyphus destructor) administered, using a rush build-up phase in subjects with allergic rhinitis or rhinoconjunctivitis, with controlled asthma.;Secondary Objective: The secondary objective is to evaluate the efficacy by means of the combined Symptom and Rescue Medication score (SMS) on nasal, ocular and pulmonary symptoms and their respective Rescue Medication score for the perennial treatment regimen of allergen extract of two mites mixes (DP/MG/14-1 and DP/MG/14-2) after 2 year of treatment compared with baseline. Other efficacy parameters will be evaluated: changes in ACT, VAS and RQLQ/AQOLQ. The exploratory objective is to gain some insight of the mechanism of action of the treatment with DP/MG/14-1 and DP/MG/14-2, administered subcutaneously by measuring immunology laboratory parameters specific IgE abd IgG4 of DP/MG/14-1 and DP/MG/14-2 completed allergen extract mites.;Primary end point(s): Subjects (%) suffering from immediate or delayed systemic ? grade 2 reactions, according to EACCI 2006 classification, along the study.;Timepoint(s) of evaluation of this end point: Safety: local and systemic adverse reactions (EAACI classification) within 24 and 48 hours after the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?Patients (%) sufering from immediate or delayed local reactions classified by the diameter of induration ( 10 cm)and dose received ?Patients (%) suffering from immediate or delayed systemic reactions classified by grade (EACCI classification) and dose received ?Patients (%) withdrawn from the study due to local reactions classified by dose received ?Patients (%) withdrawn from the study due to local reactions classified by dose received during the build-up phase ?Patients (%) withdrawn from the study due to systemic reactions classified by dose received ?Patients (%) withdrawn from the study due to systemic reactions classified by dose received during the build-up phase ?Patients (%) with adverse events (AE) classified by dose received ?Number of immediate or delayed local reactions classified by diameter of induration ( 10 cm) and dose received ?Number of immediate or delayed systemic reactions classified by grade (EACCI classification) and dose received ?Change of lung function parameters before and after each administration of the IMP. ?Change from baseline to Visit 4 in laboratory safety parameters. ?Change in symptoms and rescue medication score from baseline to final visit. ?Change in symptoms score (nasal, ocular and pulmonary symptoms) from baseline to final visit. ?Change in rescue medication score from baseline to final visit. ?Patients (%) with an improvement in symptoms and rescue medication score after treatment compared to baseline. ?Patients (%) with an improvement in symptoms score after treatment compared to baseline. ?Patients (%) with an improvement in rescue medication score after treatment compared to baseline. ?Change from baseline to final visit in ACT. ?Patients (%) with an improvement in quality of life questionnaires after treatment compared to baseline. ?Patients (%) with an improvement in VAS after treatment compared to baseline. Exploratory immunological parameters: Immunological response measured by imm | — |
Countries
Spain
Contacts
Public ContactDepartamento Médico
Laboratorios LETI, S.L.U
Outcome results
None listed