Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
89 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal