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About
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.
Full 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
Enrollment
Sex
Ages
Volunteers
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 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
Primary purpose
Allocation
Interventional model
Masking
150 participants in 3 patient groups, including a placebo group
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Central trial contact
Raquel Caballero, MD; Miguel Casanovas, MD PhD
Data sourced from clinicaltrials.gov
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