An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy

Frequency of Subjects With Systemic Reactions

Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)

Time frame: 6 weeks

Frequency of Subjects With Local Adverse Reaction

Frequency of patients with local adverse reactions

Time frame: 6 weeks

Change in Phleum Pratense Specific IgE-blocking Factor

IgE-blocking factor measures the amount of IgE bound to the allergen in the presence of allergen-competing factors present in the serum of a subject treated with allergen immunotherapy. The test is based in a double IgE measurement, an ordinary assay and an assay in the presence of competing components and takes the form of: IgE blocking factor = 1 - (Competitive IgE/Ordinary IgE). Theoretical limits are from 0 (no IgE blocked) to 1 (all IgE blocked) and, being a ratio, is a dimensionless measure

Time frame: baseline (visit 1) and at 6 weeks (visit 6)

Change in Phleum Pratense Specific IgG4

Time frame: baseline (visit 1) and at 6 weeks (visit 6)

Change in Immediate Cutaneous Response to Phleum Pratense

Wheal size provoked after prick test with 4, 20 and 100 µg/ml Phl p 5 allergen extracts analysed by Parallel Line Assay. Cutaneous Tolerance Index (CTI) is the factor it is necessary to multiply the extract concentration by after SCIT (V6) to obtain the same response in terms of wheal area as at baseline (V1). CTI, being an index, is a dimensionless measure. A CTI of 1 indicates no change in skin sensitivity while if higher than 1 a decrease in skin sensitivity (it would be needed a more concentrated allergen extract at V6 to elicit the same skin response as at V1