Intralymphatic Allergen Immunotherapy (ILIT) in grass pollen allergy: a randomized controlled trial
Key facts
- Where
- Ancona és Foggia, OlaszországSee the 2 sites
- Phase
- 3. fázis
Where in Olaszország
- Universita Politecnica Delle MarcheAncona, OlaszországNo longer taking part
- University of FoggiaFoggia, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Of Foggia
- Trial code
- EU 2025-522376-82-00
- Record updated
- 2025. december 11.
- Original description
Efficacy and safety of ILIT, in adolescents and adults with allergic rhino-conjunctivitis, with or without asthma, due to grass pollen, using currently available commercial allergen extracts (for ILIT administration), will be assessed and will represent the primary outcomes of this RCT.Read full original descriptionShow less
Efficacy and safety of ILIT, in adolescents and adults with allergic rhino-conjunctivitis, with or without asthma, due to grass pollen, using currently available commercial allergen extracts (for ILIT administration), will be assessed and will represent the primary outcomes of this RCT.
Inclusion: 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.
Exclusion: 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; 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; Pregnant or nursing; No readily accessible inguinal lymph nodes.