Phase 3 Completed N=226 Randomized Double-blind Treatment

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

allergy

Source: ClinicalTrials.gov NCT00310466 ↗

Enrolled (actual)

226

Serious AEs

2.7%

Results posted

Aug 2009

Primary outcomePrimary: Daily Rhinoconjunctivitis Symptom Score — 4.07; 4.14 Units on a scale (0-18) — p=0.87

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Daily Rhinoconjunctivitis Symptom Score	4.07; 4.14	0.87
PRIMARY Daily Rhinoconjunctivitis Rescue Medication Score	2.76; 2.54	0.55
SECONDARY Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects	48; 42	0.04 sig
SECONDARY Adverse Events	81; 87	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00310466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.