Allergic rhinoconjunctivitis with/without asthma due to sensitization to Olea europaea (olive) pollen MedDRA version: 14.1 Level: PT Classification code 10039085 Term: Rhinitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: AVANZ Olivo
Pharmaceutical Form: Suspension for injection
Current Sponsor code: AVANZ Olive
Other descriptive name: Extracto de polen de olivo
Concentration unit: SQU/ml Standardised Qua
Sponsors
ALK-Abelló, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, angiotensin converting enzyme inhibitors, tricyclic antidepressants, ?-blockers, mono amine oxidase inhibitors and any other drug containing alum taken on a daily basis. 7. Previous treatment by other allergen concomitant IT or immunotherapy with Olea europaea extracts within the previous 5 years 8. History of anaphylactic shock or of severe and recurrent angioedema.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerability of the up-dosing phase of AVANZ Olive.;Secondary Objective: Increase in IgG4 and in IgE and reduction in immediate skin reactivity;Primary end point(s): Frequency of patients with adverse reactions;Timepoint(s) of evaluation of this end point: After up-dosing phase and one maintenance dose (6 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in olive IgE and IgG4 levels from baseline to end of trial. Changes in immediate skin response to olive allergens from baseline to end of trial by parallel line assay;Timepoint(s) of evaluation of this end point: After up-dosing phase and one maintenance dose (6 weeks) | — |
Countries
Spain
Contacts
Public ContactDepartamento Médico
ALK-Abelló, S.A.
Outcome results
None listed