EUCTR2011-004852-20-ES
Active, not recruiting
Phase 1
An open trial to assess the tolerability of AVANZ Olive immunotherapy
ALK-Abelló, S.A.0 sites0 target enrollmentDecember 23, 2011
ConditionsAllergic rhinoconjunctivitis with/without asthma due to sensitization to Olea europaea (olive) pollenMedDRA version: 14.1Level: PTClassification code 10039085Term: Rhinitis allergicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Allergic rhinoconjunctivitis with/without asthma due to sensitization to Olea europaea (olive) pollen
- Sponsor
- ALK-Abelló, S.A.
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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