Clinical trial NCT02065856: An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy
Official title: An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinoconjunctivitis Due to Salsola Kali Pollen
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of patients with adverse reactions
timeFrame: Participants will be followed for an expected average of 6 weeks
Secondary outcomes:
measure: Frequency of patients with systemic reactions according to EAACI classification
timeFrame: Participants will be followed for an expected average of 6 weeks
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
Study officials:
affiliation: Hospital General Universitario de Alicante
name: PURIFICACION GONZÁLEZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: