Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
NCT ID: NCT04435990
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2020-10-06
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed.
So that neither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.
Study Groups
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Experimental:10,000 MM09
10,000 TU/mL of subcutaneous immunotherapy
10,000 MM09
Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL
Experimental: 30,000 MM09
30,000 TU/mL of subcutaneous immunotherapy
30,000 MM09
Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL
Placebo subcutaneous
The same solution and presentation as the active treatment, but without any active ingredients.
Placebo subcutaneous
The same solution and presentation as the active treatment, but without active ingredients.
Interventions
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10,000 MM09
Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL
30,000 MM09
Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL
Placebo subcutaneous
The same solution and presentation as the active treatment, but without active ingredients.
Eligibility Criteria
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Inclusion Criteria
* Age between 12 and 65, both genders.
* Subjects with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent mild-moderate controlled asthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.
* Subjects with a positive skin prick-test wheal size \>5 mm higher diameter due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The positive and negative control of the test should give consistent results. The results will be valid 12 months prior to the signing of the informed consent.
* Specific immunoglobulin E against house dust mites \>3,5 KU/mL (InmunoCAP® o Immulite), for the complete extract of Dermatophagoides pteronyssinus and / or for Dermatophagoides farinae or for some of the molecular components of these allergenic sources
* Subjects should preferably be monosensitized to the study allergens. In case of subjects sensitized to other aeroallergens, only those with the following characteristics may be included in the study:
* Subjects with positive skin test to Blomia tropicalis and Lepidoglyphus destructor, whose specific IgE values do not exceed or equal the values for the study allergens. The maximum specific IgE value for these allergens is 3.5 KU/L.
* Subjects with positive skin tests to epithelia, as long as they present occasional exposure and symptomatology.
* Subjects with positive skin tests to pollens, whose specific IgE values do not exceed or equal the values of the allergens in the study and who do not present exacerbations during the pollen season. The maximum value of specific IgE for these allergens is 17.5 KU/L.
* Subjects with negative skin test for fungi
* Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial, before the first administration of the IMP.
* Women of childbearing age participating in the trial must agree to use an appropriate method of contraception, meaning any act, device, or medication to prevent conception or viable pregnancy, during the trial if they are sexually active.
* Subjects with a diagnosis of asthma according to the GEMA 5.0 guideline.
* Subjects capable of complying with the dosing regimen.
* Subjects who own an smartphone for symptom registration and medication
Exclusion Criteria
* Subjects in whom 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 with persistent severe or uncontrolled asthma, with an FEV1\<70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom oral or systemic antihistamine therapy is contraindicated.
* Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
* Subjects under treatment with β-blockers.
* Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
* Subjects with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema.
* Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathy).
* Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
* Subject whose condition prevents him/her from offering cooperation and/or who has serious mental illness.
* Subjects with a known allergy to other components of the investigational medicinal product other than the allergen.
* Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
* Direct investigator's relatives.
* Pregnant women or breastfeeding women.
12 Years
65 Years
ALL
No
Sponsors
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BioClever 2005 S.L.
OTHER
Inmunotek S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Francisco Moreno, MD
Role: STUDY_DIRECTOR
Centro Médico ASISA
Locations
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Hospital Provincial de Conxo
Santiago de Compostela, A Coruña, Spain
IMED Elche
Elche, Alicante, Spain
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain
Clinica Tecma
Valencia, Alzira, Spain
Clinica Virgen del Rosario
Algeciras, Cadiz, Spain
Hospital HLA Jerez Puerta Sur
Jerez de la Frontera, Cádiz, Spain
Hospital Dr. Peset
Valencia, España, Spain
Hospital General Universitario Santa Maria de Rosell
Cartagena, Murcia, Spain
Hospital Rivera Povisa
Vigo, Pontevedra, Spain
Hospital General Universitario Dr. Balmis
Alicante, , Spain
Hospital Universitario San Juan de Alicante
Alicante, , Spain
Clínica Dermatológica y Alergia
Badajoz, , Spain
Hospital Quironsalud Clideba
Badajoz, , Spain
Hospital Sant Pere Claver
Barcelona, , Spain
Clínica Corachan
Barcelona, , Spain
Hospital Universitari Dexeus
Barcelona, , Spain
Cenvi Medic
Barcelona, , Spain
Allergocenter
Barcelona, , Spain
Clinica privada
Bilbao, , Spain
Centro Médico ASISA Dr. Lobatón
Cadiz, , Spain
Centro Médico Puerto
Cadiz, , Spain
Hospital Quiron Salud Córdoba
Córdoba, , Spain
Hospital Polusa
Lugo, , Spain
Clinica privada
Málaga, , Spain
Hospital Comarcal de Melilla
Melilla, , Spain
Clinica Privada
Murcia, , Spain
Alergocantabria
Santander, , Spain
Hospital Quiron Infanta Luisa
Seville, , Spain
Clinica Lanuza
Valencia, , Spain
Hospital Universitario Y Politecnico La Fe
Valencia, , Spain
Clinica IMED
Valencia, , Spain
Hospital de Sagunto
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Piacentini GL, Vicentini L, Mazzi P, Chilosi M, Martinati L, Boner AL. Mite-antigen avoidance can reduce bronchial epithelial shedding in allergic asthmatic children. Clin Exp Allergy. 1998 May;28(5):561-7. doi: 10.1046/j.1365-2222.1998.00260.x.
Yepes-Nunez JJ, Gomez C, Espinoza Y, Cardona R. [The impact of subcutaneous immunotherapy with Dermatophagoides farinae and Dermatophagoides pteronyssinus on the quality of life of patients with allergic rhinitis and asthma]. Biomedica. 2014 Apr-Jun;34(2):282-90. doi: 10.1590/S0120-41572014000200014. Spanish.
Cardona R, Lopez E, Beltran J, Sanchez J. Safety of immunotherapy in patients with rhinitis, asthma or atopic dermatitis using an ultra-rush buildup. A retrospective study. Allergol Immunopathol (Madr). 2014 Mar-Apr;42(2):90-5. doi: 10.1016/j.aller.2012.07.005. Epub 2012 Dec 20.
Bousquet J, Hejjaoui A, Clauzel AM, Guerin B, Dhivert H, Skassa-Brociek W, Michel FB. Specific immunotherapy with a standardized Dermatophagoides pteronyssinus extract. II. Prediction of efficacy of immunotherapy. J Allergy Clin Immunol. 1988 Dec;82(6):971-7. doi: 10.1016/0091-6749(88)90133-9.
Branco Ferreira M, Spinola Santos A, Pereira Santos MC, Palma Carlos ML, Pereira Barbosa MA, Palma Carlos AG. Efficacy and safety of specific immunotherapy with a modified mite extract. Allergol Immunopathol (Madr). 2005 Mar-Apr;33(2):80-5. doi: 10.1157/13072918.
Other Identifiers
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2018-004262-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MM09-SIT-023
Identifier Type: -
Identifier Source: org_study_id
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