ALLERGIC RHINOCONJUNCTIVITIS MedDRA version: 9.1 Level: SOC Classification code 10021428 Term: Immune system disorders
Conditions
Interventions
Pharmaceutical Form: Oral solution
Concentration unit: µl microlitre(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Oral solution
Route of administration of
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  Adult subjects (age>18) affected by grass-induced rhinobronchitis and/or sinusitis and having documented positive allergic tests.  No food allergy/intolerance, or food allergy/intolerance easily controlled by diet.. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients presenting the following conditions won?t be enrolled into the clinical experiment:  Patients with severe food allergy (especially mussels and/or crayfish)  Patients with latex allergy.  Patients already on a desensitizing immunotherapy schedule  No cooperation by the patient  Other conditions that make Immunospecific Therapy unrecommended according to the SIAIC Memorandum and/or EAACI Position Paper (1993):  Major comorbidities  Contraindications to adrenalin administration (e.g. coronary artery disease)  Moderate-to-severe atopic dermatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: assessment of the effectiveness of grass-specific immunotherapy administered through the sublingual/oral route;Secondary Objective: in vivo assessment of the degree of desensitization and assessment of the respiratory function through FEF75;Primary end point(s):  Abatement of symptoms  Reduction of symptomatic drug consumption during patients? exposure to pollen  Prolongation of the Disease-Free Interval. | — |
Countries
Italy
Outcome results
None listed