Phase 3
N=226
Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever
Allergy
Bottom Line
View on ClinicalTrials.gov: NCT00310466 ↗Enrolled (actual)
226
Serious AEs
2.7%
Results posted
Aug 2009
Primary outcome: Primary: Daily Rhinoconjunctivitis Symptom Score — 4.07; 4.14 Units on a scale (0-18) — p=0.87
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sublingual immunotherapy (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ALK-Abelló A/S
- Primary completion
- Aug 2006
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 | — |
Summary
The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy
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
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.