Clinical trial NCT04435990: Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
Official title: Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Clinical Trial With SCIT in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to Dpt. and/or D. Farinae
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rhinitis, Allergic
Rhinoconjunctivitis
Asthma, Allergic
Keywords: Rhinitis/ Rhinoconjunctivitis
Mild to moderate asthma
Allergy
Immunotherapy
Mites
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
Collaborators: name: BioClever 2005 S.L.
First posted: 2020-06-17
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
Primary purpose: TREATMENT

Brief summary: A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.

Detailed description: Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 12 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS

Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* 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 who have received previous immunotherapy in the previous 5 years to dander, fungi, and mites.
* 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.

Primary outcomes:
measure: CSMS: Combined Symptoms and Medication Score
timeFrame: 12 months
Secondary outcomes:
measure: Medication-free days
timeFrame: 12 months
measure: Symptom-free days
timeFrame: 12 months
measure: Number of participants with treatment-related adverse events as assessed by MM09-SIT-023
timeFrame: 12 months
measure: Quality of life associated with asthma
timeFrame: 12 months
measure: Quality of life associated with rhinitis
timeFrame: 12 months
measure: Visual Analogue Scale (VAS)
timeFrame: 12 months
measure: Immunological parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Provincial de Conxo
state: A Coruña
city: Elche
country: Spain
facility: IMED Elche
state: Alicante
city: Torrevieja
country: Spain
facility: Hospital Universitario de Torrevieja
state: Alicante
city: Valencia
country: Spain
facility: Clinica Tecma
state: Alzira
city: Algeciras
country: Spain
facility: Clinica Virgen del Rosario
state: Cadiz
city: Jerez De La Frontera
country: Spain
facility: Hospital HLA Jerez Puerta Sur
state: Cádiz
city: Valencia
country: Spain
facility: Hospital Dr. Peset
state: España
city: Cartagena
country: Spain
facility: Hospital General Universitario Santa Maria de Rosell
state: Murcia
city: Vigo
country: Spain
facility: Hospital Rivera Povisa
state: Pontevedra
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Alicante
country: Spain
facility: Hospital Universitario San Juan de Alicante
city: Badajoz
country: Spain
facility: Clínica Dermatológica y Alergia
city: Badajoz
country: Spain
facility: Hospital Quironsalud Clideba
city: Barcelona
country: Spain
facility: Hospital Sant Pere Claver
city: Barcelona
country: Spain
facility: Clínica Corachan
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus
city: Barcelona
country: Spain
facility: Cenvi Medic
city: Barcelona
country: Spain
facility: Allergocenter
city: Bilbao
country: Spain
facility: Clinica privada
city: Cadiz
country: Spain
facility: Centro Médico ASISA Dr. Lobatón
city: Cadiz
country: Spain
facility: Centro Médico Puerto
city: Córdoba
country: Spain
facility: Hospital Quiron Salud Córdoba
city: Lugo
country: Spain
facility: Hospital Polusa
city: Melilla
country: Spain
facility: Hospital Comarcal de Melilla
city: Murcia
country: Spain
facility: Clinica Privada
city: Málaga
country: Spain
facility: Clinica privada
city: Santander
country: Spain
facility: Alergocantabria
city: Sevilla
country: Spain
facility: Hospital Quiron Infanta Luisa
city: Valencia
country: Spain
facility: Clinica Lanuza
city: Valencia
country: Spain
facility: Hospital Universitario Y Politecnico La Fe
city: Valencia
country: Spain
facility: Clinica IMED
city: Valencia
country: Spain
facility: Hospital de Sagunto
Study officials:
affiliation: Centro Médico ASISA
name: Francisco Moreno, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.