House dust mites allergy MedDRA version: 20.0 Level: LLT Classification code 10020419 Term: House dust mite allergy System Organ Class: 100000004870 MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853 MedDRA version: 21.1 Level: LLT Classification code 10034382 Term: Perennial allergic rhinitis System Organ Class: 100000004855
Conditions
Interventions
Product Name: MM09-I
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: MM09-I
Other descriptive name: HOUSE DUST MITE ALLERGEN EXTRACT
Concentration unit: AU/m
Sponsors
Inmunotek, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent - Positive suggestive clinical history of inhalation allergy (moderate-severe persistent/ rhinitis/ rhinoconjunctivitis with mild-moderate controlled persistent asthma) due to Dermatophagoides pteronyssinus and / or Dermatophagoides farinae allergy - Subjects with a positive prick test (wheal size > 5 mm) - Specific immunoglobulin E against house mites (Dermatophagoides pteronyssinus and/or Dermatophagoides farinae) > 10 kU/L (Class 3) and whose determinations does not exceed 6 months prior to the inclusion visit - Subjects that are not sensitized to environmental allergens from other groups (pollens, mushrooms, animal epithelia, food, medicines or poisons). - Subjects with diagnosis of asthmatic pathology performed by bronchodilator test or patients with previous diagnosis of asthma by clinical history - Age between 14 and 65 years - Both genders - Subjects capable of complying with the study protocol - Subjects who have not received immunotherapy in the last 5 years Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Subjects who have not given written informed consent - Subjects outside of the age range - Subjects who have previously received immunotherapy for the treatment of the allergic rhinoconjunctivitis and asthma in the last 5 years., or a cross-reactive allergen or are currently receiving immunotherapy with any allergen -Subjects that immunotherapy can be subject to absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and of the European Allergy and Clinical Immunology Immunotherapy Subcommittee - Subjects with intermittent or severe persistent or uncontrolled asthma, with a FEV1<60% with respect to the reference value despite the appropiate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent rhinitis or with moderate to severe symptoms in whom the suspension of the systemic antihistamine treatment is contraindicated -- Subjects who have required oral corticosteroids in the 12 weeks previous to the inclusion in the trial - Subjects who have previously suffered a serious secondary reaction during the skin prick test -Subjects in treatment with beta blockers -Unstable subjects from the clinical point of view at the time of the inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile, acute urticaria, etc.) -Subjects with chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema -Subjects with some pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.) -Subjects with any other disease not associated with the moderate rhinoconjunctivitis or asthma, but of potential severity and that could interfere with the treatment and follow-up (epilepsy, psychomotor deterioration, diabetes, malformations, multi-operated, kidney diseases,…). -Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiency -Subject whose status prevents him from providing cooperation and/or who presents severe psychiatric disorders -Subjects with known allergy to other vaccine components different from mite allergen extract -Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis -Direct investigator’s relatives -Pregnant or women at risk of pregnancy women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical efficacy of polymerized allergenic extracts, administered subcutaneously, compared to placebo in subjects with moderate to severe persistent/ intermittent rhinoconjunctivitis associated with mild to severe persistent/intermittent asthma in mites sensitized subjects, without sensitization to other pneumoallergens, by combining the symptoms and the consumption of the medicine necessary for the control of asthma with rhinitis / rhinoconjunctivitis.;Secondary Objective: As secondary objectives will be assessed the tolerance, changes in immunological parameters, the subject quality of life, after the treatment and the safety of the subcutaneous immunotherapy;Primary end point(s): Combined symptom and medication score at the beginning and the end of the trial that will be evaluated by the symptom diary.;Timepoint(s) of evaluation of this end point: Begining and end of the clinical trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Skin prick test - Free days of symptoms and medication - Asthmatic Exacerbations (Number, severity and time) - Quality of life - Visual analogue scales - Immunological parameters: total and specific IgE; IgG (specific IgG4) - Registration of health consumption - Safety variables;Timepoint(s) of evaluation of this end point: Begining and end of the clinical trial | — |
Countries
Spain
Contacts
Public ContactMiguel Casanovas
INMUNOTEK, S.L.
Outcome results
None listed