Randomized, placebo-controlled, prospective clinical trial of efficacy and safety for the treatment of rhinitis/rhinoconjunctivitis and asthma against a mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extract

Phase 1

• Conditions: House dust mites allergy; MedDRA version: 20.0Level: LLTClassification code 10020419Term: House dust mite allergySystem Organ Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; MedDRA version: 21.1Level: LLTClassification code 10034382Term: Perennial allergic rhinitisSystem Organ Class: 100000004855

• Registration Number: EUCTR2018-004262-34-ES
• Lead Sponsor: Inmunotek, S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-14
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

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

Inclusion Criteria

- Written informed consent
- Positive suggestive clinical history of inhalation allergy (moderate-severe persistent/ rhinitis/ rhinoconjunctivitis with mild-moderate controlled persistent asthma) due to Dermatophagoides pteronyssinus and / or Dermatophagoides farinae allergy
- Subjects with a positive prick test (wheal size > 5 mm)
- Specific immunoglobulin E against house mites (Dermatophagoides pteronyssinus and/or Dermatophagoides farinae) > 10 kU/L (Class 3) and whose determinations does not exceed 6 months prior to the inclusion visit
- Subjects that are not sensitized to environmental allergens from other groups (pollens, mushrooms, animal epithelia, food, medicines or poisons).
- Subjects with diagnosis of asthmatic pathology performed by bronchodilator test or patients with previous diagnosis of asthma by clinical history
- Age between 14 and 65 years
- Both genders
- Subjects capable of complying with the study protocol
- Subjects who have not received immunotherapy in the last 5 years
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Subjects who have not given written informed consent
- Subjects outside of the age range
- Subjects who have previously received immunotherapy for the treatment of the allergic rhinoconjunctivitis and asthma in the last 5 years., or a cross-reactive allergen or are currently receiving immunotherapy with any allergen
-Subjects that immunotherapy can be subject to absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and of the European Allergy and Clinical Immunology Immunotherapy Subcommittee
- Subjects with intermittent or severe persistent or uncontrolled asthma, with a FEV1<60% with respect to the reference value despite the appropiate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent rhinitis or with moderate to severe symptoms in whom the suspension of the systemic antihistamine treatment is contraindicated
-- Subjects who have required oral corticosteroids in the 12 weeks previous to the inclusion in the trial
- Subjects who have previously suffered a serious secondary reaction during the skin prick test
-Subjects in treatment with beta blockers
-Unstable subjects from the clinical point of view at the time of the inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile, acute urticaria, etc.)
-Subjects with 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 with some pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.)
-Subjects with any other disease not associated with the moderate rhinoconjunctivitis or asthma, but of potential severity and that could interfere with the treatment and follow-up (epilepsy, psychomotor deterioration, diabetes, malformations, multi-operated, kidney diseases,…).
-Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiency
-Subject whose status prevents him from providing cooperation and/or who presents severe psychiatric disorders
-Subjects with known allergy to other vaccine components different from mite allergen extract
-Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis
-Direct investigator’s relatives
-Pregnant or women at risk of pregnancy women

Study & Design

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