Double blind, placebo-controlled, dose finding, prospective, multicenter clinical trial for the treatment of rhinitis/rinoconjuntivitis against a mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extract
- Conditions
- Therapeutic area: Diseases [C] - Immune System Diseases [C20]Mites allergyMedDRA version: 18.0Level: LLTClassification code 10020419Term: House dust mite allergySystem Organ Class: 100000004870
- Registration Number
- EUCTR2015-000820-27-ES
- Lead Sponsor
- Inmunotek, S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 180
- Written informed consent
- Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate asthma, due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae
- Subjects with a positive skin prick-test (wheal sixe >6 mm diameter) to a Dermatophagoides pteronyssinus and/or Dermatophagoides farinae allergen extract
- Specific IgE against house dust mites >10 kU/L and and whose determination does not exceed 6 months prior to the inclusion visit
- Age between 12 and 65 years
- Both genders
- Subjects capable of giving informed consent
- Subjects capable of complying with the dosing regimen
- Subjects that have not received immunotherapy against mites in the last 5 years
- Subjects submitting sensitization to other aeroallergens, but is considered clinically irrelevant or without clinical interference with the nasal provocation test.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Subjects outside of the age range.
- Subjects who have previously received immunotherapy for the treatment of the allergic rhinitis/rhinoconjunctivitis due to mites and other allergens in the last 5 years.
- Subjects that immunotherapy may be an absolute 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 may also include.
- Subjects with important symptoms of rhinoconjunctivitis in which the suspension of the systemic antihistamine treatment is contraindicated.
- Subjects with persistent severe or not controlled asthma, with a FEV< 70 respect to the reference value in spite of the appropriate pharmacological treatment at the time of the inclusion in the trial.
- Subjects that have required oral corticosteroids in the 12 weeks previous to the inclusion in the trial.
- Subjects who receive or have received omalizumab
- Subjects who can not stop treatment with intranasal corticosteroids
- Subjects with persistent asthma treated with inhaled intranasal corticosteroids
- Subjects treated with angiotensin converting enzyme inhibitors ( ACEIs )
- Subjects that have some pathology (hyperthyroidism, hypertension, heart disease, etc.) in which immunotherapy is contraindicated.
- Subjects in treatment with beta blockers.
- Subjects that have previously submitted a serious secondary reaction during the skin prick test
- Subject with active chronic urticaria in the last 2 years
- Subjects with hereditary angioedema.
- Subjects with any other disease not associated with the rhinitis/rhinoconjunctivitis, but of potential severity and that could interfere with treatment and follow-up (epilepsy, psychomotor deterioration, malformations, kidney diseases,...).
- Subjects with tumor diseases
- Subject diagnosed or diagnosed with immunodeficiencies
- Subjects with chronic sinusitis
- Subjects with acute otitis media
- Subjects with active positive dermographism
- Subjects with structural alterations of the nasal fossa ( polyps , deviated septum, turbinate hypertrophy, not alterable nasal obstruction, nasal vasoconstriction , etc
- Subject whose status prevents him from providing cooperation and or which present severe psychiatric disorders.
- Subject with known allergy to other components of the vaccine different from mites 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 and breastfeeding women.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Establish a dose-response relationship for the treatment of rhinitis/rhinoconjunctivitis due to mites allergy treatment sublingual therapy.;Secondary Objective: As secondary objectives will be assessed the efficacy, tolerance and safety of four concentrations for both immunotherapy subcutaneous and sublingual immunotherapy.<br>The influence of treatment on the following parameters were also assessed:<br>- Dose response skin prick test<br>-Evolution of symptoms<br>- Medication consumption<br>- Quality of life;Primary end point(s): Change of the threshold concentration necessary to cause a reaction positive after the test of nasal provocation (TPN) between the start and the end of the trial, by acoustic rhinometry.;Timepoint(s) of evaluation of this end point: Begining and end of the clinical trial
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Dose finding skin prick test<br>- Safety variables<br>-Symptoms and concomitant medication consumption<br>-Quality of life<br>-Immunological parameters;Timepoint(s) of evaluation of this end point: Begining and end of the clinical trial