Allergy
Conditions
Keywords
Sublingual immunotherapy, Grass pollen tablet, Allergic rhinoconjunctivitis
Brief summary
To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage
Interventions
DRUG100 IR grass pollen allergen extract tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
One sublingual tablet daily during 4 months before pollen season and during pollen season
DRUG500 IR grass pollen allergen extract tablet
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
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Written consent * Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons. * Sensitised to grass pollen (positive SPT and RAST level of at least class 2). * Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12. * Safety laboratory resuts within the references ranges
Exclusion criteria
* Pregnancy, breast-feeding/lactation * Had received desensitisation treatment for grass pollen * Treatment by immunotherapy with another allergen within the previous 5 years * Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies * Treated with beta-blockers or under continuous corticotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Rhinoconjunctivitis Total Symptom Score | Pollen period (average of 32 days in the ITT set) | 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. |
Participant flow
Recruitment details
First Patient First Visit 30 NOV 2004, Last Patient Last Visit 05 SEP 2005
Participants by arm
| Arm | Count |
|---|---|
| 100 IR 100 IR grass pollen allergen extract tablet | 142 |
| 300 IR 300 IR grass pollen allergen extract tablet | 136 |
| 500 IR 500 IR grass pollen allergen extract tablet | 143 |
| Placebo Placebo tablet | 148 |
| Total | 569 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 6 | 8 | 0 |
| Overall Study | Any other reason not above-mentioned | 7 | 5 | 3 | 4 |
| Overall Study | Withdrawal by Subject | 8 | 11 | 8 | 6 |
Baseline characteristics
| Characteristic | 100 IR | 300 IR | 500 IR | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 29.3 years STANDARD_DEVIATION 6.9 | 28.7 years STANDARD_DEVIATION 7.34 | 30.4 years STANDARD_DEVIATION 7.45 | 29.1 years STANDARD_DEVIATION 7.6 | 29.4 years STANDARD_DEVIATION 7.34 |
| Sex: Female, Male Female | 69 Participants | 62 Participants | 54 Participants | 60 Participants | 245 Participants |
| Sex: Female, Male Male | 73 Participants | 74 Participants | 89 Participants | 88 Participants | 324 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 74 / 160 | 70 / 155 | 76 / 157 | 36 / 156 |
| serious Total, serious adverse events | 3 / 160 | 1 / 155 | 0 / 157 | 0 / 156 |
Outcome results
Primary
Average Rhinoconjunctivitis Total Symptom Score
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 32 days in the ITT set)
Population: The intent-to-treat (ITT) population included all patients who received at least one dose of 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 |
|---|---|---|---|
| 100 IR | Average Rhinoconjunctivitis Total Symptom Score | 4.72 Units on a scale (range: 0 to 18) | Standard Deviation 3.141 |
| 300 IR | Average Rhinoconjunctivitis Total Symptom Score | 3.58 Units on a scale (range: 0 to 18) | Standard Deviation 2.976 |
| 500 IR | Average Rhinoconjunctivitis Total Symptom Score | 3.74 Units on a scale (range: 0 to 18) | Standard Deviation 3.142 |
| Placebo | Average Rhinoconjunctivitis Total Symptom Score | 4.93 Units on a scale (range: 0 to 18) | Standard Deviation 3.229 |
Comparison: A step-down approach is performed to address the multiplicity issue.p-value: 0.0006ANCOVA
Comparison: A step-down approach is performed to address the multiplicity issue.p-value: 0.0001ANCOVA
Comparison: A step-down approach is performed to address the multiplicity issue.p-value: 0.4606ANCOVA