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

Study Overview
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Brief Summary
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The purpose of this study is to assess the tolerability of AVANZ.

Detailed Description
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To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of patients with adverse reactions will be the study primary endpoint.

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

Conditions
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Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Drug: AVANZ Phleum pratense


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of grass pollen rhinoconjunctivitis Positive SPT to Phleum pratense Positive specific IgE against Phleum pratense Exclusion Criteria: Uncontrolled severe asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVANZ Phleum pratense<br>AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection | Drug: AVANZ Phleum pratense<br>* AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Subjects With Adverse Drug Reactions | Frequency of patients with adverse reactions, local or systemic | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 weeks | 
| Frequency of Subjects With Local Adverse Reaction | Frequency of patients with local adverse reactions | 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 | baseline (visit 1) and at 6 weeks (visit 6) | 
| Change in Phleum Pratense Specific IgG4 |  | 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 | baseline (visit 1) and at 6 weeks (visit 6) |