Mild to moderate asthma and allergic rhinitis / rhinoconjunctivitis (intermittent or persistent) due to hypersensitivity to house dust mites (Dermatophagoides pteronyssinus and / or D. farinae) and grass pollen. 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 MedDRA version: 20.0 Level:
Conditions
Interventions
Product Name: MM09-MG01(30.000-30.000)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: N/A
Current Sponsor code: MG01
Other descriptive name: Mixture of polymerized with glutaraldeh
Sponsors
Inmunotek, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have signed the informed consent 2. Subjects with a confirmed medical history of asthma (intermittent or persistent mild-moderate, controlled), as defined by GEMA 5 with rhinitis / rhinoconjunctivitis (intermittent or persistent) according to the ARIA classification caused by polysensitization to grass pollen and mites (D. pteronyssinus and / or D. farinae). 3. Subjects with a positive prick test (average diameter of the papule = to 5 mm) to a standardized extract of grass pollen mixture, or to one of the components of the mixture (Dactilys glomerata, Poa pratensis, Holcus lanatus, Festuca elatior, Phleum pratense and Lolium perenne) and to an extract of D. pteronyssinus and / or D. farinae, tested within the 12 months prior to signing the informed consent. 4. Specific IgE (CAP or Immulite) against one of the components of the mixture of grasses, preferably Phleum pratense and mites (D. pteronyssinus and / or D. farinae) or one or more of the molecular components of allergenic sources with a value = 3 KU / L, tested within the 12 months prior to signing the informed consent. 5. Subjects aged between 18 and 65 years. 6. Subjects capable of complying with the dosing regimen. 7. Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of enrolment in the trial. 8. Women of childbearing potential and men participating in the trial should commit to using an adequate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months in advance, surgical sterilization (for example, tubal ligation), barrier methods, or the use of oral contraceptives. 9. Subjects who have a smartphone to record symptoms and medication. 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Subjects who have received prior immunotherapy treatment in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen. 2. Subjects sensitized to other aeroallergens other than grass or mites pollen belonging to the genus Dermatophagoides, with the exception of epithelia as long as the subject has occasional exposure and symptoms. 3. Patients in whom immunotherapy may be the object of an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee cannot be included. 4. Subjects with uncontrolled severe asthma, and / or with a FEV1 <70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. 5. Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test. 6. Subjects under treatment with ß-blockers. 7. Subjects under treatment with immunosuppressive or biological drugs. 8. Clinically unstable subjects at the time of inclusion in the trial (respiratory infection, feverish process, acute urticaria, etc.). 9. Subjects with chronic urticaria in the past 2 years, severe anaphylaxis, or a history of hereditary angioedema. 10. Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.). 11. Subjects with some other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, diabetes, malformations, subjects who underwent multiple surgeries, kidney disease...), according to investigator’s criteria. 12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or with a diagnosis of immunodeficiencies. 13. Subject whose condition prevents him / her from offering cooperation and or who presents severe psychiatric disorders, according to investigator criteria. 14. Subjects with known allergies to other investigational product components other than grass pollen or mites. 15. Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis. 16. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical efficacy of subcutaneously administered polymerized allergenic extracts, compared to placebo, in subjects with controlled intermittent or persistent (mild-moderate) asthma, with allergic (intermittent or persistent) rhinitis / rhinoconjunctivitis, polysensitized to mites and grasses, using combined score and consumption of medication for asthma and rhinitis / rhinoconjunctivitis for each trial subject.;Secondary Objective: To assess the safety and indirect efficacy of polymerized allergenic extracts administered subcutaneously, under the conditions mentioned above, by comparisons between active groups and placebo, both at the beginning and at the end of the trial, on the secondary variables: -Symptom-free and medication-free days for asthma and rhinitis. -FEV1 and PEF measurement -Time elapsed until the first appearance of asthmatic exacerbations, number, duration and severity. -Immunological parameters (total and specific IgE, specific IgE index / total IgE specific IgE for relevant allergens, specific IgG and specific IgG4). -Analog visual scale. -Quality of life using ESPRINT-15 questionnaires. -Control of asthma by ACT test. -Consumption of health resources. -Global rate and severity of AE per administration and per subject. -Reactions at the administration site and any medication administered for the treatment of AE.;Primary end point(s): Score of symptoms and medication throughout the trial, for both asthma and rhinitis/rhinoconjunctivitis.;Timepoint(s) of evaluation of this end point: Beginning and end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A quantitative comparison will be made both at the beginning and at the end of the trial for each subject and between the different groups of active treatment and placebo (group treated with extract of mites and group treated with extract of grass pollen compared with group treated with mixture of the two allergens (mites and grasses) and both against placebo) of the following parameters: - In asthma: Symptom-free days and Medication-free days - In rhinitis: Symptom-free days and medication-free days - Measurement of FEV1 and PEF - Time elapsed until the first appearance of asthmatic exacerbations, number, duration and severity. - Severity of symptoms of rhinitis / rhinoconjunctivitis and its evolution during the study period - Immunological parameters: 1. Total IgE, specific IgE, IgE specific to relevant allergens 2. Specific IgG and specific IgG4 3. Specific IgE / total IgE index - Analog visual scale - Asthma Control Test (ACT) - Quality of life questionnaire for rhinitis ESPRINT-15 - Consumption of health resources - Security variables: 1. Overall rate, severity and ratio of any AE by administration and by subject. ? 2. Assessment of local tolerability, administration site reactions, and any medications administered for the treatment of AE.;Timepoint(s) of evaluation of this end point: Beginning and end of the trial | — |
Countries
Spain
Contacts
Public ContactMedical Department
Inmunotek, S.L.
Outcome results
None listed