An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy

Study Overview
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Brief Summary
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This trial is an open, national, multi-centre trial. The trial will be initiated in December 2013 and subjects will receive treatment for 6 weeks. Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with immediate access to Adverse Events registered in the clinical database. The composition, procedures and deliverables of the Clinical Safety Group will be detailed in a Safety Agreement prior to trial start.

Official Title
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An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy

Conditions
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Allergic Rhinoconjunctivitis Due to Salsola Kali Pollen

Intervention / Treatment
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* Biological: AVANZ Salsola


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A clinical history of Salsola kali pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry. Positive Skin Prick Test to Salsola kali pollen (wheal diameter ≥ 3 mm). Documenting in the last 5 years a positive specific Immunoglobulin E against Salsola kali pollen (≥ Class 2; ≥0.70 KU/L). Exclusion Criteria: Forced expiratory volume at one second 1 < 70% of predicted value at screening after adequate pharmacologic treatment. Uncontrolled or severe asthma. History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months. At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion). Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication). Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis. Immunotherapy with Cupressus arizonica or Salsola kali pollen extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted) or concomitant immunotherapy with any other allergen. History of anaphylactic shock due to e.g. food, insect venom, exercise or drug. History of severe and recurrent angioedema.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVANZ Salsola kali<br>Subcutaneous immunotherapy | Biological: AVANZ Salsola<br>* AVANZ Salsola<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of patients with adverse reactions |  | Participants will be followed for an expected average of 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of patients with systemic reactions according to EAACI classification |  | Participants will be followed for an expected average of 6 weeks |