Seasonal Allergic Rhinitis
Conditions
Keywords
Sublingual immunotherapy, Rhinitis, Conjunctivitis, Allergen challenge, Allergen exposition chamber, Grass pollen tablet, Allergic rhinoconjunctivitis
Brief 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.
Detailed 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.
Interventions
300 IR grass pollen allergen extract tablet once daily during four months
DRUGPlacebo tablet
Placebo tablet once daily during four months
Sponsors
Stallergenes Greer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours | 4 months | The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (\]0-4\] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS \]0-4\] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome. |
Countries
Austria
Participant flow
Recruitment details
First Patient First Visit 17 SEP 2007, Last Patient Last Visit 10 MAR 2008
Participants by arm
| Arm | Count |
|---|---|
| 300 IR 300 IR grass pollen allergen extract tablet | 45 |
| Placebo Placebo tablet | 44 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | 300 IR | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 27.46 years STANDARD_DEVIATION 6.577 | 27.12 years STANDARD_DEVIATION 5.807 | 27.29 years STANDARD_DEVIATION 6.175 |
| Sex: Female, Male Female | 24 Participants | 28 Participants | 52 Participants |
| Sex: Female, Male Male | 21 Participants | 16 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 45 | 9 / 44 |
| serious Total, serious adverse events | 0 / 45 | 0 / 44 |
Outcome results
Primary
Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours
The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (\]0-4\] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS \]0-4\] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome.
Time frame: 4 months
Population: The Intent-to-treat (ITT) population included all randomised subjects who received at least one dose of the investigational product.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 IR | Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours | 4.88 Units on a scale (range: 0 to 18) | Standard Error 0.363 |
| Placebo | Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours | 6.84 Units on a scale (range: 0 to 18) | Standard Error 0.367 |
p-value: 0.000395% CI: [-2.99, -0.94]ANCOVA