Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.

  • STATUS
    Recruiting
  • End date
    Apr 22, 2023
  • participants needed
    180
  • sponsor
    Inmunotek S.L.
Updated on 22 August 2021

Summary

A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.

Description

Double blind, multicenter, parallel, placebo controlled study. It includes 150 subjects sensitised to cupressaceae and grass pollen, from 14 to 65 years of age. Medication treatment during 1 year. The main outcome: CSMS

Details
Condition Allergic Rhinitis, Rhinoconjunctivitis, Allergic Asthma
Treatment Placebo subcutaneous, 10,000 MG01 +10,000 T521, 30,000 MG01 +10,000 T521
Clinical Study IdentifierNCT04898283
SponsorInmunotek S.L.
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent
Aged between 14 and 65, both genders
Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate intermittent or persistent asthma,according to GEMA 5.0, due to grass and cupressaceae pollen
Subjects with a positive skin prick-test (wheal sixe >5 mm diameter). The positive and negative control of the test should give consistent results and whose determination does not exceed 1 year prior to the baseline visit
Specific immunoglobulin E class 3 , against grass and cupressaceae pollen (InmunoCAP o Immulite) and whose determination does not exceed 1 year prior to the inclusion visit
Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial
Women of childbearing potential, and men participating in the trial, should commit to using an appropriate 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
Subjects with asthma must be diagnosed according to the GEMA 5.0 guideline
Subjects capable of complying with the dosing regimen
Subjects who own a smartphone for symptom registration and medication

Exclusion Criteria

Subjects polisensitised to other aeroallergens but sensitisation to epithelia with exposure and occasional symptoms or sensitisation to pollen noncoseasonal with cupressus or grasses
Subjects who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen
Subjects in which immunotherapy may be subject to 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
Subjects have not granted written informed consent
Subjects with severe or uncontrolled intermittent or persistent asthma, with an FEV1 <70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated
Subjects who have previously had a severe secondary reaction during the prick test diagnostic skin test
Subjects treated with beta-blockers
Clinically unstable subjects at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc.)
Subjects with active 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 who have any pathology in which adrenaline administration is contraindicated (hyperthyroidism, HTN, heart disease, etc.)
Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multioperated patients, kidney disease,)
Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies
Subject whose condition prevents from offering cooperation and/ or who has severe psychiatric disorders
Subjects with a known allergy to components of the investigational medicinal product other than the allergen
Subjects with lower respiratory diseases other than asthma such as emphysema or bronchiectasis
Subjects who are direct relatives of the researchers
Pregnant or lactating women
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