Clinical trial developed at various hospitals where each patient randomly receive in parallel groups either placebo or treatment. Nor patients or investigators will know what the patient it's being given. This clinical trial evaluates efficacy and safety of the immunotherapy with allergen Cup a 1” (major protein in Cupressus arizónica) in patients with allergic rhinoconjunctivitis with or without asthma sensitized to Cupressaceae polle

Phase 1

• Conditions: Allergic patients to the Cupressaceae pollen with moderate/severe allergic rhino conjunctivitis with or without controlled asthma; MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2022-000615-31-ES
• Lead Sponsor: Diater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-24
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified