EUCTR2013-001728-20-ES
Active, not recruiting
Not Applicable
An open trial to assess the tolerability of AVANZ® Salsola immunotherapy
ALK-Abelló S. A.0 sitesSeptember 5, 2013
ConditionsAllergic rhinoconjunctivitis with or without asthma due to sensitisation to Salsola kali pollenMedDRA version: 16.1Level: PTClassification code 10039085Term: Rhinitis allergicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Allergic rhinoconjunctivitis with or without asthma due to sensitisation to Salsola kali pollen
- 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
- •1\.Male and female patients 18\-65 years of age.
- •2\.A clinical history of Salsola kali pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
- •3\.Positive SPT to Salsola kali pollen (wheal diameter \> 3 mm).
- •4\.Documenting in the last 5 years a positive specific IgE against Salsola kali 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
- •1\.FEV1 \< 70% of predicted value at screening after adequate pharmacologic treatment.
- •2\.Uncontrolled or severe asthma.
- •3\.History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
- •4\.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).
- •5\.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).
- •6\.Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, ?\-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis.
- •7\.Immunotherapy with Salsola kali pollen extracts within the previous 5 years
- •8\.Concomitant immunotherapy with any other allergen
Outcomes
Primary Outcomes
Not specified
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