Allergic Rhinoconjunctivitis Due to Salsola Kali Pollen Clinical Trial
— AV-X-02Official title:
An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy
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.
| Status | Completed |
| Enrollment | 51 |
| Est. completion date | December 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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, ß-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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital General Universitario de Alicante | Alicante |
| Lead Sponsor | Collaborator |
|---|---|
| ALK-Abelló A/S |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency of patients with adverse reactions | Participants will be followed for an expected average of 6 weeks | Yes | |
| Secondary | Frequency of patients with systemic reactions according to EAACI classification | Participants will be followed for an expected average of 6 weeks | Yes |