Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
Status and phase
Terminated
Phase 2
Conditions
Allergy
Treatments
Biological: Subcutaneous immunotherapy - Recombinant birch pollen
Details and patient eligibility
About
To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.
Sex
All
Ages
18 to 50 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or mild asthma range 1 and 2 GINA.
- Positive history of birch pollen allergy (clinical history, positive skin prick test, birch specific IgE, presence of birch pollen)
- Compliant patients
- Written consent.
Exclusion criteria
- Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal danders, mites, alternaria cladosporium
- Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA.
- Patients treated with beta-blockers or under continuous oral corticosteroids.
- Pregnant women
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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