Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

  • STATUS
    Recruiting
  • End date
    Sep 9, 2022
  • participants needed
    140
  • sponsor
    Inmunotek S.L.
Updated on 9 December 2021
tubal ligation
asthma
rhinitis
dermatophagoides farinae
dermatophagoides pteronyssinus
surgical treatment

Summary

Prospective, randomized, placebo-controlled, multicenter of 3 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with 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

Description

Double blind, parallel placebo-controlled study. The subjects will receive medication during 11 months

Details
Condition hayfever, seasonal allergy, Perennial allergic rhinitis, House Dust Mite Allergy, pollen allergy, Allergic Rhinoconjunctivitis, Hay fever, Rhinitis, Allergic, Perennial
Treatment Placebo subcutaneous, MM09-MG01(30.000-30.000), MG01(30.000), MM09(30.000)
Clinical Study IdentifierNCT04874714
SponsorInmunotek S.L.
Last Modified on9 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects who have signed the informed consent
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). The diagnosis of asthma will be valid from 24 months prior to signing the informed consent
Subjects with a positive prick test (major 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
Specific IgE (CAP or Immulite) against one of the components of the mixture of grasses, preferably Phleum pratense or a mixture of grasses and mites (D. pteronyssinus and / or D. farinae) or one or more of the molecular components of allergenic sources with a value > 3,5 KU / L
Subjects aged between 18 and 65 years
Subjects capable of complying with the dosing regimen
Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of enrolment in the trial
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
Subjects who have a smartphone to record symptoms and medication

Exclusion Criteria

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 aeroallergen
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
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
Subjects with severe or uncontrolled 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
Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test
Subjects under treatment with -blockers
Subjects under treatment with immunosuppressive or biological drugs
Clinically unstable subjects at the time of inclusion in the trial (respiratory infection, feverish process, acute urticaria, etc.)
Subjects with chronic urticaria in the past 2 years, severe anaphylaxis, or a history of hereditary angioedema
Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.)
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
Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or with a diagnosis of immunodeficiencies
Subject whose condition prevents him / her from offering cooperation and or who presents severe psychiatric disorders, according to investigator criteria
Subjects with known allergies to other investigational product components other than grass pollen or mites
Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis
Pregnant or lactating women
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