EUCTR2013-004720-11-ES
Active, not recruiting
Not Applicable
An open trial to assess the tolerability of AVANZ® Cupressus immunotherapy
ALK-Abelló, S.A.0 sitesDecember 27, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ALK-Abelló, S.A.
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female aged 18\-65 years.
- •A documented clinically relevant history of Cupressus arizonica pollen induced allergic rhinoconjunctivitis with or without asthma for at least one year prior to trial entry.
- •Positive Skin Prick Test (SPT) response to Cupressus arizonica pollen (wheal diameter ? 3 mm) .
- •Documenting in the last 5 years a positive specific IgE against Cupressus arizonica pollen (? Class 2; ?0\.70 KU/L).
- •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 50
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •A clinical history of uncontrolled asthma within 3 months prior to screening .
- •Reduced lung function (FEV1 \< 70% of predicted value) after adequate pharmacologic treatment.
- •History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
- •Previous treatment with immunotherapy with Cupressus arizonica pollen extract within the last 5 years Ongoing treatment with any allergen\-specific immunotherapy product.
- •At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant process.
- •A history of anaphylaxis with cardiorespiratory symptoms.
- •A history of recurrent generalised urticaria during the last 2 years.
- •A history of drug\-induced facial angioedema or a family history of hereditary angioedema.
- •Any clinically relevant chronic disease
- •A systemic disease affecting the immune system.
Outcomes
Primary Outcomes
Not specified
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