Primary Disease
Conditions
Keywords
allergic rhinoconjunctivitis
Brief summary
The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.
Detailed description
To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on: \- The Average Adjusted Symptom Score (AASS). To document the safety of the treatment.
Interventions
DRUG300 IR
300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season
DRUGPlacebo
Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass 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
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female outpatients aged 12 to 65 years (inclusive). 2. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons. 3. Positive SPT 4. RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.
Exclusion criteria
1. Positive SPT to any other seasonal allergens present during the grass pollen season 2. Patients with clinically significant confounding symptoms of allergy to other allergens 3. Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed. 4. Patients with moderate or severe persistent asthma (Global Initiative for Asthma \[GINA\] 3 or 4).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Adjusted Symptom Score (AAdSS) | Pollen period (average of 32.1 days) | The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the 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, Italy, Spain
Participant flow
Recruitment details
First Patient First Visit 28 JAN 2009, Last Patient Last Visit 31 AUG 2009
Participants by arm
| Arm | Count |
|---|---|
| 300 IR 300 IR grass pollen allergen extract tablet | 178 |
| Placebo Placebo tablet | 185 |
| Total | 363 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Any other reason not above-mentioned | 4 | 10 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | 300 IR | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 30.5 years STANDARD_DEVIATION 10.53 | 29.6 years STANDARD_DEVIATION 9.87 | 30.0 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 77 Participants | 79 Participants | 156 Participants |
| Sex: Female, Male Male | 101 Participants | 106 Participants | 207 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 110 / 188 | 63 / 193 |
| serious Total, serious adverse events | 1 / 188 | 1 / 193 |
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 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 32.1 days)
Population: The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score during the pollen period while on treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 300 IR | Average Adjusted Symptom Score (AAdSS) | 5.58 Units on a scale (range: 0 to 18) | Standard Error 0.33 |
| Placebo | Average Adjusted Symptom Score (AAdSS) | 6.07 Units on a scale (range: 0 to 18) | Standard Error 0.335 |
p-value: 0.234495% CI: [-1.3, 0.32]ANCOVA
Post Hoc
Combined Score (CS)
The daily Combined Score (CS) is a patient specific score taking into account the patient's daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores. The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms). The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome.
Time frame: Pollen period (average of 32.1 days)
Population: The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Combined Score during the pollen period while on treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 300 IR | Combined Score (CS) | 0.38 Units on a scale (range: 0 to 3) | Standard Error 0.038 |
| Placebo | Combined Score (CS) | 0.48 Units on a scale (range: 0 to 3) | Standard Error 0.038 |
p-value: 0.040195% CI: [-0.18, 0]ANCOVA