Allergy
Conditions
Keywords
Sublingual immunotherapy, Grass pollen tablet, Allergic rhinoconjunctivitis
Brief summary
A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis
Interventions
DRUG300 IR (4M)
300 IR grass pollen allergen extract tablet starting 4 months before the pollen season
DRUG300 IR (2M)
300 IR grass pollen allergen extract tablet starting 2 months before the pollen season
DRUGPlacebo
Placebo tablet
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 aged 18 to 50 years * Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons * Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens * A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS)
Exclusion criteria
* Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included. * Asthma requiring treatment other than beta-2 inhaled agonists. * Patients who have received any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Adjusted Symptom Score (AAdSS) | Pollen period (average of 33.8 days) of Year 3 | The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the Year 3 pollen period while on treatment, 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). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome. |
Countries
France
Participant flow
Recruitment details
First Patient First Visit 08 DEC 2006, Last Patient Last Visit 07 SEP 2011
Participants by arm
| Arm | Count |
|---|---|
| 300 IR (4M) 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season | 188 |
| 300 IR (2M) 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season | 188 |
| Placebo Placebo tablet | 205 |
| Total | 581 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Year 1 | Adverse Event | 9 | 15 | 3 |
| Year 1 | Any other reason not above-mentioned | 2 | 5 | 7 |
| Year 1 | Withdrawal by Subject | 7 | 8 | 5 |
| Year 2 | Adverse Event | 5 | 2 | 1 |
| Year 2 | Any other reason not above-mentioned | 2 | 1 | 6 |
| Year 2 | Withdrawal by Subject | 1 | 1 | 3 |
| Year 3 | Any other reason not above-mentioned | 2 | 1 | 1 |
| Year 3 | Withdrawal by Subject | 1 | 1 | 2 |
| Year 4 | Adverse Event | 0 | 1 | 0 |
| Year 4 | Any other reason not above-mentioned | 1 | 1 | 0 |
| Year 4 | Withdrawal by Subject | 2 | 3 | 2 |
| Year 5 | Adverse Event | 0 | 1 | 0 |
| Year 5 | Any other reason not above-mentioned | 2 | 4 | 3 |
Baseline characteristics
| Characteristic | 300 IR (4M) | 300 IR (2M) | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 30.9 years STANDARD_DEVIATION 8.25 | 30.4 years STANDARD_DEVIATION 7.57 | 30.2 years STANDARD_DEVIATION 8.56 | 30.5 years STANDARD_DEVIATION 8.14 |
| Sex: Female, Male Female | 66 Participants | 77 Participants | 83 Participants | 226 Participants |
| Sex: Female, Male Male | 122 Participants | 111 Participants | 122 Participants | 355 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 179 / 207 | 167 / 207 | 170 / 219 |
| serious Total, serious adverse events | 9 / 207 | 7 / 207 | 6 / 219 |
Outcome results
Primary
Average Adjusted Symptom Score (AAdSS)
The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the Year 3 pollen period while on treatment, 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). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome.
Time frame: Pollen period (average of 33.8 days) of Year 3
Population: Full Analysis Set Year 3 (FASY3). FASY3 included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score (AdSS) during the pollen period while on treatment during the Year 3.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 300 IR (4M) | Average Adjusted Symptom Score (AAdSS) | 3.39 Units on a scale (range: 0 to 18) | Standard Error 0.357 |
| 300 IR (2M) | Average Adjusted Symptom Score (AAdSS) | 3.25 Units on a scale (range: 0 to 18) | Standard Error 0.369 |
| Placebo | Average Adjusted Symptom Score (AAdSS) | 5.21 Units on a scale (range: 0 to 18) | Standard Error 0.348 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA