Allergic Rhinitis Due to Olea Europaea Pollen Clinical Trial
Official title:
An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy
| Verified date | April 2013 |
| Source | ALK-Abelló A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Spanish Agency of Medicines |
| Study type | Interventional |
This trial is an open, national, multi-centre trial. The trial will be initiated after olive
pollen season 2012 and subjects will receive treatment for 6 weeks.
The aim of study is to assess the tolerability of the up-dosing phase of AVANZ Olive. The
frequency of patients with adverse reactions will be the primary endpoint.
Frequency of patients with systemic reactions according to EAACI classification, increase in
IgG4 and in IgE and reduction in immediate skin reactivity.
| Status | Completed |
| Enrollment | 93 |
| Est. completion date | April 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: 1. Male and female patients 18-65 years of age. 2. A clinical history of olive pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry. 3. Positive SPT to olive pollen (wheal diameter = 3 mm). 4. A positive specific IgE against olive pollen (=Class 2; =0.70 KU/L) documented in the last 5 y Exclusion Criteria: 1. FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment. 2. Uncontrolled or severe asthma. 3. A clinically relevant history of symptomatic perennial allergic rhinitis and/or conjunctivitis caused by an allergen to which the subject is regularly exposed and sensitized. 4. History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months. 5. 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). 6. 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). 7. 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. 8. Previous treatment by other allergen concomitant IT or immunotherapy with Olea europaea 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). 9. History of anaphylactic shock due to e.g. food, insect venom, exercise or drug. 10. History of severe and recurrent angioedema. 11. Any contraindication according to the Investigator Brochure (IB). 12. Use of an investigational drug within 30 days prior to screening. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario Reina Sofía | Córdoba |
| Lead Sponsor | Collaborator |
|---|---|
| ALK-Abelló A/S |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency of patients with adverse reactions. | From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject. | Participants will be followed for an expected average of 6 week.s | Yes |
| Secondary | Frequency of patients with systemic reactions according to EAACI classification. | From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject. | Participants will be followed for an expected average of 6 weeks. | Yes |