Allergy
Conditions
Keywords
Sublingual immunotherapy, Grass pollen tablet, Allergic rhinoconjunctivitis
Brief summary
A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.
Interventions
One sublingual tablet daily during 4 months before pollen season and during pollen season
DRUGPlacebo tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
Sponsors
Stallergenes Greer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female outpatients aged 5 to 17 years. * Written consent / assent. * Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. * Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2). * Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.
Exclusion criteria
* Patients who have received any desensitisation treatment for grass pollen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Rhinoconjunctivitis Total Symptom Score (ARTSS) | Pollen period (average of 38.6 days) | Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome. |
Countries
Germany
Participant flow
Recruitment details
First Patient First Visit 16 DEC 2006, Last Patient Last Visit 12 SEP 2007
Participants by arm
| Arm | Count |
|---|---|
| 300 IR 300 IR grass pollen allergen extract tablet | 131 |
| Placebo Placebo tablet | 135 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 2 |
| Overall Study | Any other reason not above-mentioned | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | 300 IR | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 10.5 years STANDARD_DEVIATION 3.34 | 11.2 years STANDARD_DEVIATION 3.07 | 10.9 years STANDARD_DEVIATION 3.22 |
| Sex: Female, Male Female | 45 Participants | 50 Participants | 95 Participants |
| Sex: Female, Male Male | 86 Participants | 85 Participants | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 107 / 139 | 96 / 139 |
| serious Total, serious adverse events | 2 / 139 | 2 / 139 |
Outcome results
Primary
Average Rhinoconjunctivitis Total Symptom Score (ARTSS)
Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome.
Time frame: Pollen period (average of 38.6 days)
Population: The Intent-to-treat (ITT) population included all patients who received at least one dose of the investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 IR | Average Rhinoconjunctivitis Total Symptom Score (ARTSS) | 3.25 Units on a scale (range: 0 to 18) | Standard Deviation 2.86 |
| Placebo | Average Rhinoconjunctivitis Total Symptom Score (ARTSS) | 4.51 Units on a scale (range: 0 to 18) | Standard Deviation 2.931 |
p-value: 0.001ANCOVA