Allergic Rhinoconjunctivitis Due to Salsola Kali Pollen
Conditions
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.
Interventions
BIOLOGICALAVANZ Salsola
AVANZ Salsola
Sponsors
ALK-Abelló A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of patients with adverse reactions | Participants will be followed for an expected average of 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of patients with systemic reactions according to EAACI classification | Participants will be followed for an expected average of 6 weeks |
Countries
Spain
Outcome results
None listed