Intralymphatic Allergen Immunotherapy (ILIT) in grass pollen allergy: a randomized controlled trial

Prior treatment

• Contraindications to the use of the Investigational Medicinal Product (i.e. hypersensitivity to any of the excipients of the standardized allergen extract modified with glutaraldehyde (allergoid) adsorbed onto L-tyrosine for delayed subcutaneous specific immunotherapy, severe chronic and inflammatory diseases, multiple sclerosis, autoimmune diseases, immunodeficiencies, active pulmonary and ocular tuberculosis, severe psychiatric disorders, cardiovascular insufficiency, chronic heart and/or lung diseases, malignant diseases, current concomitant treatment with beta-blockers or ACE inhibitors, febrile infections of the respiratory tract), or of the placebo (i.e. hypersensitivity to phenol or to any of the other excipients).
• Previous grass pollen AIT
• Chronic therapy with corticosteroids (≥10 mg/day of prednisone or equivalent for >2 weeks)
• Immunosuppressive drugs

Other illness

• Significant year-round allergy symptoms or minor year-round symptoms without worsening during grass pollen seasons
• Clinically relevant allergy to Parietaria pollen
• Significant cardiovascular, hepatic, renal, autoimmune, hematological, psychiatric or active infectious disease
• Pulmonary disease, other than seasonal asthma but including perennial asthma, with perennial use of inhaled corticosteroids

Other

• Pregnant or nursing
• No readily accessible inguinal lymph nodes

• Patients aged 18 or older
  • Patients affected by moderate to severe allergic rhino-conjunctivitis (according to ARIA definition) diagnosed through a positive skin prick test - wheal, 3 mm larger than negative control-, and circulating specific IgE (minimum 0.5 kU/l) to grass pollen)
• History of moderate-to-severe allergic rhinitis during the previous pollen season, documented at screening by a Symptom Score ≥ 7, or, if a previous Symptom Score is unavailable, by a self-reported retrospective visual analogue scale (VAS) rating of nasal and/or ocular symptoms ≥ 4/10 cm (0 = no symptoms; 10 = worst imaginable symptoms), obtained using a standardized questionnaire (VAS question: ‘Considering the period of worst symptoms during last pollen season, how severe were your nasal and/or ocular symptoms?’) and referring to the two-week period of peak symptom severity during the previous season (April–June).
• Provision of signed and dated informed consent form approved from IRB/IEC