Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Biological: Placebo; Biological: Sublingual immunotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00310466

SHX0712

Details and patient eligibility

About

The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy

Full description

Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events

Enrollment: 226 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A history of birch pollen allergy
• Positive skin prick test to birch
• Positive conjunctival test to birch
• Positive specific Immunoglobulin E (IgE) to birch

Exclusion criteria

• Forced expiratory volume in 1 second (FEV1)<70% of predicted value
• History of seasonal allergy interfering with study
• History of symptomatic perennial allergy
• History of emergency visit or admission for asthma in the previous 12 month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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226 participants in 2 patient groups, including a placebo group

Sublingual immunotherapy

Active Comparator group

Description:

sublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose)

Treatment:

Biological: Sublingual immunotherapy

Placebo

Placebo Comparator group

Description:

placebo sublingual drops

Treatment:

Biological: Placebo