Grass pollen allergy MedDRA version: 18.0 Level: LLT Classification code 10036019 Term: Pollen allergy System Organ Class: 100000004870
Conditions
Interventions
Product Name: MG56-I
Product Code: MG56-I
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Other descriptive name: POLLEN ALLERGEN EXTRACTS
Concentration unit: BAU/ml Bioequivalent
Sponsors
INMUNOTEK, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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 grass pollen allergy - Subjects with a positive skin prick-test (wheal sixe >6 mm diameter) Specific IgE (CAP >3) to grass pollen - Age between 14 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 and or mites, cats or dogs, but that is considered clinically not relevant or no clinical interference with the nasal provocation test. Are the trial subjects under 18? yes Number of subjects for this age range: 20 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) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Subjects outside of the age range. - Subjects who have previously received immunotherapy for the treatment of the allergic rhinitis/rhinoconjunctivitis due to grass pollen 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 FEV< 70 respect to the reference value in spite of the appropiate 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 rinitis/rinoconjuntivitis, but of potential severity and that could interfere with treatment and follow-up (epilepsy, psychomotor deterioration, diabetes, malformations, multioperados, 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 pollen of grasses. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Establish a dose-response relationship for the treatment of rhinitis/rhinoconjunctivitis due to grass pollen allergy;Secondary Objective: As secondary objectives will be assessed efficacy, tolerance and safety of four concentrations, for both immunotherapy subcutaneous and sublingual immunotherapy.;Primary end point(s): - Changes in the threshold concentration required to elicit a positive response after nasal provocation test (NPT ) between the begining and end of trial;Timepoint(s) of evaluation of this end point: Beguining and end of the clinical trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Dose finding skin prick test - Immunological parameters - Safety variables - Comparation of each group versus placebo - Comparation between subcutaneous immnunotherapy groups vesus sublingual mmnunotherapy groups;Timepoint(s) of evaluation of this end point: At the beginign and the end of the trial | — |
Countries
Spain
Contacts
Public ContactMiguel Casanovas
INMUNOTEK, S.L.
Outcome results
None listed