Allergic patients to the Cupressaceae pollen with moderate/severe allergic rhino conjunctivitis with or without controlled asthma MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: Cup a 1 purified and isolated protein
Product Code: Cup a 1 MOL
Pharmaceutical Form: Solution for injection in vial
INN or Proposed INN: Cup a 1 purified an isolated protein
Other descri
Sponsors
Diater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female from 12 to 65 years of age included. 2. Obtaining informed consent to participate in the study, as well as guardians or legal representatives, in case of minor. 3. Moderate or severe allergic rhinitis or rhinoconjunctivitis, according to the modified ARIA classification, with or without controlled asthma, by demonstrated sensitization to Cupressaceae. 4. Cupressus or Cup a 1 IgE levels greater or equal than 2 kU/l (classes 3 to 6). 5. Positive skin prick test (=3 mm in diameter) with Diater extract for Cupressaceae and Cup at 1. 6. Clinically relevant symptoms against cupresaceae. 7. Willingness to comply with all protocol requirements and availability for follow-up throughout the duration of the trial. 8. Negative urine pregnancy test for women of childbearing potential (fertile from menarche to postmenopause, unless sterilized due to hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and willing to use effective contraception from 14 days before the first administration until 30 days after the last investigational product administration. Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Clinically relevant polysensitization: epithelia if they coexist with animals, mites, fungi and pollens at the investigator's discretion. 2. Nasal or paranasal recent or scheduled pathology or surgery that may interfere with the trial, such as polyposis, at the investigator's discretion. 3. Uncontrolled serious systemic diseases, such as autoimmune, cardiovascular, hyperthyroidism, liver disease or kidney failure, malignant tumours or chronic infection. 4. Uncontrolled asthma despite optimal pharmacological treatment. 5. Having received immunotherapy to cupresaceae or phylogenetically related allergens in the 5 years prior to the start of the trial. 6. Being in concomitant treatment with another immunotherapy against other allergens during the trial. 7. Adrenaline use contraindication. 8. Active tuberculosis. 9. Severe atopic eczema. 10. Dermographism, pathologies or skin alterations that interfere with the evaluation of skin tests. 11. Psychiatric disorder that prevents adequate compliance with the immunotherapy program. 12. Pregnant or lactating woman. 13. Simultaneous participation in another clinical trial. 14. Any disease that interferes with the absorption or elimination of the investigational products. 15. Chronic abuse of alcohol or any other type of substance that, in the opinion of the investigator, may interfere with the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of efficacy of specific immunotherapy with the purified and isolated protein Cup a 1 administered subcutaneously in patients sensitized to the allergen under study.;Secondary Objective: • Analysis of additional efficacy parameters to the combined index of symptom frequency and severity score together with rescue medication consumption score. • Evaluate the variation of follow-up skin tests with Cupressaceae and Cup a 1 extracts. • Control of asthma and allergic rhinitis assessment, using the ACT and the modified ARIA scale. • Patient's health status assessment using the VAS scale. • Quality of life evaluation according to rhinitis (ESPRINT-15). • Evaluate the immunological markers related to efficacy: IL-10, IL-13, INF-?, IgG4, total IgE and specific IgE against Cupressus arizonica and Cup a 1. • Evaluate the degree of tolerance against conjunctival provocation with Cupressaceae extract. • Evaluation of the safety of the treatment, through the registry of AA and AAG.;Primary end point(s): The efficacy of the treatment will be evaluated based on the symptom frequency and severity score together with the Combined Symptom and Medication Score (CSMS), which will be obtained through a questionnaire completed by the patient during 2 pollen seasons.;Timepoint(s) of evaluation of this end point: Visits V8, V9, V10, V20, V21 and V22 matching visits with January, February and march 2023 and 2024 (polinic season) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Symptom frequency and severity score. Results are compared between treatment groups and between pollen seasons. 2.Score for Rescue medication use. 3.Symptom-free days. 4.Medication-free days. 5.Extra visits and/or emergencies during the period of the clinical trial related to the pathology under study. 6.Skin follow-up skin test with Cupressaceae extract and Cup a 1. 7.Asthma and allergic rhinitis control assessed by ACT and modified ARIA 8.Visual Analog Scale (VAS) for the state of health performed by the patient. 9.ESPRINT-15 questionnaire evaluation. 10.Evaluation of immunological markers: IL-10, IL-13, INF-?, specific IgE and specific IgG4 against Cupressus arizonica and Cup a 1. 11.Conjunctival provocation against cupresaceae. 12.Frequency of adverse events (AEs), serious AAs (SAEs) and ADRs, particularly systemic events according to the World Allergy Organization (WAO) 2010 classification.;Timepoint(s) of evaluation of this end point: 1.Visits V8, V9, V10, V20, V21 and V22 matching visits with January, February and march 2023 and 2024 2.Visits V8, V9, V10, V20, V21 and V22 matching visits with January, February and march 2023 and 2024 3.Daily during 50 days during the two pollen seasons 4.Daily during 50 days during the two pollen seasons 5.Throughout the study 6.V0, V11 y V27 7. SCR, V11 y V27 8.SCR and Visits V8, V9, V10, V20, V21, V22 and matching visits with January, February and march 2023 and 2024 9.SCR y Visitas V8, V9, V10, V20, V21, V22 and matching visits with January, February and march 2023 and 2024 10.V0, V3, V7, V11 and V27 11.SCR, V11( matching visit with April 2023) and V27 12.Throughout the study | — |
Countries
Spain
Contacts
Public ContactClinical Trial Departament
Diater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas
Outcome results
None listed