An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy (AV-X-02)

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinoconjunctivitis Due to Salsola Kali Pollen
• Intervention / Treatment: Biological: AVANZ Salsola

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain
    • Hospital General Universitario de Alicante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVANZ Salsola kali; Subcutaneous immunotherapy	Biological: AVANZ Salsola; AVANZ Salsola

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Investigators: Principal Investigator: PURIFICACION GONZÁLEZ, PhD, Hospital General Universitario de Alicante

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: February 17, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Estimate): January 14, 2015
• Last Update Submitted That Met QC Criteria: January 13, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2013-001728-20 (EudraCT Number)