Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite Allergy
Phase 2
- Conditions
- RhinoconjunctivitisRhinitis
- Interventions
- Biological: MM09 Mannosylated 50.000 subcutaneousBiological: MM09 Mannosylated 5.000 sublingualBiological: MM09 Mannosylated 30.000 sublingualBiological: MM09 Mannosylated 30.000 subcutaneousBiological: MM09 Mannosylated 5.000 subcutaneousBiological: MM09 Mannosylated 10.000 subcutaneousBiological: MM09 Mannosylated 10.000 sublingualBiological: MM09 Mannosylated 50.000 sublingualBiological: Sublingual placeboBiological: Subcutaneous placebo
- Registration Number
- NCT02661854
- Lead Sponsor
- Inmunotek S.L.
- Brief Summary
The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against mite allergy
- Detailed Description
Double blind placebo-controlled study. The subjects will receive medication during 4 months.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 186
Inclusion Criteria
- 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 allergy
- Subjects with a positive skin prick-test (wheal sixe >6 mm diameter)
- Specific immunoglobulin E against house dust mites >10 kU/L 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 in the last 5 years
- Subjects presenting sensitization to another aeroallergens, but that is considered clinically not relevant or no clinical interference with the nasal provocation test.
Exclusion Criteria
- 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 /bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
- Subjects with persistent severe or not controlled asthma , with a forced expiratory volume (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 that have previously submitted a serious secondary reaction during the skin prick test
- Subjects in treatment with beta blockers.
- Unstable subjects from the clinical point of view (respiratory infection, febrile, acute urticaria, etc.) at the time of the inclusion in the clinical trial
- Subject with chronic urticaria in the last 2 years or hereditary angioedema.
- Subjects that have some pathology (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
- 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, diabetes, malformations, multi-operated, kidney diseases,...).
- Subjects with autoimmune disease (lupus, thyroiditis, etc.), tumor or with diagnosis of immunodeficiency diseases.
- 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
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MM09 Mannosylated 30.000 subcutaneous Sublingual placebo 30.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. MM09 Mannosylated 50.000 subcutaneous MM09 Mannosylated 50.000 subcutaneous 50.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. MM09 Mannosylated 50.000 subcutaneous Sublingual placebo 50.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. MM09 Mannosylated 5.000 sublingual Subcutaneous placebo 5.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. MM09 Mannosylated 5.000 sublingual MM09 Mannosylated 5.000 sublingual 5.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. MM09 Mannosylated 10.000 sublingual Subcutaneous placebo 10.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. MM09 Mannosylated 30.000 sublingual MM09 Mannosylated 30.000 sublingual 30.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. MM09 Mannosylated 10.000 subcutaneous Sublingual placebo 10.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. MM09 Mannosylated 30.000 subcutaneous MM09 Mannosylated 30.000 subcutaneous 30.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. MM09 Mannosylated 30.000 sublingual Subcutaneous placebo 30.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. Placebo Sublingual Placebo subcutaneous Sublingual placebo Sublingual and subcutaneous placebo. MM09 Mannosylated 5.000 subcutaneous MM09 Mannosylated 5.000 subcutaneous 5.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. MM09 Mannosylated 5.000 subcutaneous Sublingual placebo 5.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. MM09 Mannosylated 10.000 subcutaneous MM09 Mannosylated 10.000 subcutaneous 10.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. MM09 Mannosylated 10.000 sublingual MM09 Mannosylated 10.000 sublingual 10.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. MM09 Mannosylated 50.000 sublingual Subcutaneous placebo 50.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. MM09 Mannosylated 50.000 sublingual MM09 Mannosylated 50.000 sublingual 50.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. Placebo Sublingual Placebo subcutaneous Subcutaneous placebo Sublingual and subcutaneous placebo.
- Primary Outcome Measures
Name Time Method Concentration required to elicit a positive response after nasal provocation test (NPT) 4 months Change in the threshold concentration of mite allergen extract, measured in Histamine Equivalent Prick per ml (HEP/ml), needed to trigger a positive response after nasal provocation test (NPT) assessed by acoustic rhinometry.
This will be compared between the beginning and end of the trial and among active groups and placebo.
- Secondary Outcome Measures
Name Time Method Dose finding skin prick test 4 months Comparison between the beginning and end of the trial and among active groups and placebo
Number of participants with treatment-related adverse events as assessed by MM09-SIT-013 4 months Comparison between the beginning and end of the trial and among active groups and placebo
Trial Locations
- Locations (14)
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Hospital Del Vinalopo
🇪🇸Elche, Alicante, Spain
Hospital General Universitario de Elda-Virgen de La Salud
🇪🇸Elda, Alicante, Spain
Hospital Vithas Internacional Medimar
🇪🇸Alicante, Spain
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE Adults
🇪🇸Valencia, Spain
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE child
🇪🇸Valencia, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
Hospital Vega Baja Orihuela
🇪🇸Orihuela, Alicante, Spain
Hospital de La Plana
🇪🇸Vila-real, Castellón, Spain
Hospital Universitari de Castelló
🇪🇸Castellón de la Plana, Castellón, Spain
Hospital Lluis Alcanyis de Xátiva
🇪🇸Xátiva, Valencia, Spain
Hospital de Manises
🇪🇸Manises, Valencia, Spain