ALLERGENIC EXTRACT OF OLEA EUROPAEA POLLEN POLYMERIZED WITH GLUTARALDEHYDE; ALLERGEN EXTRACT FROM PHLEUM PRATENSE POLLEN, GLUTARALDEHYDE-MODIFIED; FESTUCA PRATENSIS POLLEN ALLERGOID, GLUTARALDEHYDE-MODIFIED; HOLCUS LANATUS POLLEN ALLERGOID, GLUTARALDEHYDE-MODIFIED; ALLERGEN EXTRACT FROM POA PRATENSIS POLLEN, GLUTARALDEHYDE-MODIFIED; ALLERGEN EXTRACT FROM DACTYLIS GLOMERATA POLLEN, GLUTARALDEHYDE-MODIFIED; ALLERGEN EXTRACT FROM LOLIUM PERENNE POLLEN, GLUTARALDEHYDE-MODIFIED for Allergic rhinitis/rhinoconjunctivitis|Allergic asthma

Inclusion criteria

• {"criterion_text":"-1.\tSubject who has signed the informed consent form."}
• {"criterion_text":"-10.\tSubjects with negative skin prick test for co-seasonal pollens. In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs."}
• {"criterion_text":"-11.\tSubjects with negative skin prick test to other aeroallergens (mites, fungi, and dander). In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs."}
• {"criterion_text":"-2.\tSubjects of both sexes aged between 12 and 65 years."}
• {"criterion_text":"-3.\tSubjects with a confirmed clinical history of inhalation allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without controlled intermittent or persistent mild-moderate asthma according to the GEMA 5.0 classification) caused by grass and olive tree allergy. The asthma diagnosis will be valid from 12 months prior to signing the informed consent."}
• {"criterion_text":"-4.\tSubjects with a positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized mixed extract of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or to one of the components of the mixture and an olive tree extract."}
• {"criterion_text":"-5.\tSpecific IgE (CAP or Immulite) to a grass mixture or to one of the components of the grass mixture, preferably to Phleum pratense and olive tree or to one of the molecular components of the allergenic sources with a value > 3.5 KU/L."}
• {"criterion_text":"-6.\tWomen of childbearing age (from menarche) must present a urine pregnancy test with negative result at the time of entry into the trial."}
• {"criterion_text":"-7.\tWomen of childbearing age participating in the trial must agree to use an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices inserted at least 3 months in advance, surgical sterilisation (e.g., tubal ligation), barrier methods, or the use of oral contraceptives."}
• {"criterion_text":"-8.\tSubjects capable of complying with the dosing regimen."}
• {"criterion_text":"-9.\tSubjects owning a smartphone to record symptoms and medication."}

Exclusion criteria

• {"criterion_text":"-1.\tSubjects with positive skin prick test to other aeroallergens, except for dander with occasional exposure and symptomatology."}
• {"criterion_text":"-10.\tSubjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.)."}
• {"criterion_text":"-11.\tSubjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathy)."}
• {"criterion_text":"-12.\tSubjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies."}
• {"criterion_text":"-13.\tSubject whose condition prevents him/her from offering cooperation and/or who has severe psychiatric disorders."}
• {"criterion_text":"-14.\tSubjects with known allergy to components of the investigational medicinal product other than the allergen."}
• {"criterion_text":"-15.\tSubjects with lower respiratory tract diseases different from asthma such as emphysema or bronchiectasis."}
• {"criterion_text":"-16.\tSubjects who are immediate family members of investigators."}
• {"criterion_text":"-17.\tPregnant or breastfeeding women."}
• {"criterion_text":"-2.\tSubjects with positive skin prick test to other aeroallergens, except for non-co-seasonal pollens with grasses and olive tree."}
• {"criterion_text":"-3.\tSubjects who have received immunotherapy to pollens in the last 5 years or are currently receiving immunotherapy with any allergen."}
• {"criterion_text":"-4.\tSubjects in whom immunotherapy may be subject to 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."}
• {"criterion_text":"-5.\tSubjects with persistent severe or uncontrolled asthma, with an FEV1 < 70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom discontinuation of oral or systemic antihistamine treatment is contraindicated."}
• {"criterion_text":"-6.\tSubjects who have previously presented a severe secondary reaction during diagnostic skin prick test."}
• {"criterion_text":"-7.\tSubjects on treatment with ß-blockers."}
• {"criterion_text":"-8.\tClinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, febrile process, acute urticaria, etc.)."}
• {"criterion_text":"-9.\tSubjects with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema."}

Primary endpoints

• {"endpoint_text":"-Overall symptom and medication score during the grass and olive tree pollen season (April, May, and June)","definition_or_measurement_approach":"Not specified beyond the endpoint wording: measured as overall symptom and medication score during the grass and olive tree pollen season (April, May, and June)."}

Secondary endpoints

• {"endpoint_text":"-Symptom-free days","definition_or_measurement_approach":"Not specified in the available data."}
• {"endpoint_text":"-Medication-free days","definition_or_measurement_approach":"Not specified in the available data."}
• {"endpoint_text":"-Asthma exacerbations","definition_or_measurement_approach":"Not specified in the available data."}
• {"endpoint_text":"-Visual Analogue Scale (VAS)","definition_or_measurement_approach":"Not specified in the available data."}
• {"endpoint_text":"-Immunological parameters: total IgE, specific IgE, specific IgG4","definition_or_measurement_approach":"Not specified in the available data."}
• {"endpoint_text":"-Asthma Control Questionnaire (ACQ-6)","definition_or_measurement_approach":"Not specified in the available data."}
• {"endpoint_text":"-Rhinitis quality of life questionnaire (ESPRINT-15)","definition_or_measurement_approach":"Not specified in the available data."}
• {"endpoint_text":"-Consumption of health resources","definition_or_measurement_approach":"Not specified in the available data."}
• {"endpoint_text":"-Safety of specific immunotherapy (Overall rate, severity, and ratio of any adverse event (AE) by administration and by subject; Assessment of administration site reactions, systemic reactions and any medication administered for the treatment of AE)","definition_or_measurement_approach":"Safety assessed by overall rate, severity, and ratio of any adverse event by administration and by subject; assessment of administration site reactions, systemic reactions and any medication administered for treatment of AEs, as stated in the endpoint description."}

Spain

Earliest CTIS Part Ii Submission Date

14-08-2024

Latest Decision Or Authorization Date

14-08-2024

Processing Time Days

0

Number Of Sites

24

Number Of Participants

180

Primary sponsor

Full Name

Inmunotek S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain