Rhinitis, Allergic, Rhinoconjunctivitis, Asthma, Allergic
Conditions
Keywords
Rhinitis/ Rhinoconjunctivitis, Mild to moderate asthma, Allergy, Immunotherapy, Mites
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
Interventions
BIOLOGICAL10,000 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
BIOLOGICAL30,000 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
BIOLOGICALPlacebo subcutaneous
The same solution and presentation as the active treatment, but without active ingredients.
Sponsors
BioClever 2005 S.L.
Inmunotek S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
During the trial, both the investigator and the included subjects will be unaware of the treatment each subject is receiving. 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.
Intervention model description
Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSMS: Combined Symptoms and Medication Score | 12 months | Evaluation of the number of symptoms and the consumption of medication for symptoms rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication-free days | 12 months | Number of days that the subjects need no medication |
| Symptom-free days | 12 months | Number of days that the subjects have no symptom |
| Quality of life associated with asthma | 12 months | The quality of life associated with asthma will be measured following the GINA questionnaire. The GINA questionnaire consists of 4 questions. In questions 1-4, patients recall their experience during the last 4 weeks and answer using YES or NO. The interpretation of the answers is as follows: Well-controlled: None of the answers are YES Partly controlled: 1 - 2 answers are YES Uncontrolled: 3-4 answers are YES |
| Number of participants with treatment-related adverse events as assessed by MM09-SIT-023 | 12 months | Comparison between the beginning and end of the trial and among active groups and placebo |
| Visual Analogue Scale (VAS) | 12 months | Visual Analogue Scale in which the subject has to indicate how he/she feels regarding to his allergy symptoms at the moment from 1 to 10. Being 1 very bad and 10 very well. |
| Immunological parameters | 12 months | Analyses of total IgE and specific IgA,IgG and IgG4 |
| Quality of life associated with rhinitis | 12 months | The quality of life associated with rhinitis will be measured following the test ESPRINT-15. The scoring of the questionnaire will be carried out as follows: The global sum of the scores (ranging from 0 = nothing has bothered me to 6 = it has bothered me a lot) of the 14 items plus the score given in the general questionnaire (ranging from 0 = Excellent to 4 = Bad). This sum is divided by the total number of items (15 items). The interpretation of the scores is between 0 (low impact) and 6 (high impact). |
Countries
Spain
Contacts
Primary ContactMiguel Casanovas, MD PhD
Backup ContactRaquel Caballero, MD
Outcome results
None listed