Phase 1
Completed N=89
Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
Source: ClinicalTrials.gov NCT00619827 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours — 4.88; 6.84 Units on a scale (range: 0 to 18) — p=0.0003
Summary
The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours |
4.88; 6.84 | 0.0003 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients 18-50 years old
- grass pollen rhinoconjunctivitis of at least 2 years.
- positive specific skin prick test and a specific IgE dosage level of at least 0.70 kU/L at screening.
- written consent
- a positive response to the baseline challenge test (RTSS reaches 7 at one time-point at least during baseline challenge)
Exclusion Criteria
- Allergic rhino-conjunctivitis due to a co-sensitisation, likely to significantly change the symptoms of the subject throughout the study
- Asthma requiring treatment other than short-acting beta-2 inhaled agonists.
- Desensitisation treatment for grass pollen in the previous five years and current immunotherapy with another allergen.
Data sourced from ClinicalTrials.gov (NCT00619827). 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.