Allergic Rhinitis Due to Grass Pollens
Conditions
Keywords
allergic rhinoconjunctivitis
Brief summary
The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.
Detailed description
Allergy is one of the most common chronic disease in the world currently affecting between 10% and 25% of the general population. Allergies to pollens characteristically result in seasonal rhinitis symptoms and allergic rhinoconjunctivitis is characterized by sneezing, congestion, rhinorrhea, nasal or palatal itching and itchy, watery, red and swollen eyes. Even if several drugs effectively manage allergic rhinoconjunctivitis symptoms, immunotherapy is considered more appropriate for patients in whom these symptoms are not optimally controlled with relief medications. In the study, each of the six rhinoconjunctivitis symptoms (sneezing, runny nose, itchy nose, nasal congestion, itchy eyes, watery eyes) will be evaluated daily and relief medication intake (oral antihistamines, eye drop antihistamine, nasal corticosteroid, oral corticosteroid) reported daily during the grass pollen season. Efficacy and good safety profile of 300IR SLIT tablet administered once per day for approximately six months (starting 4 months before and over the season) will be demonstrated during the grass pollen season compared to placebo.
Interventions
DRUG300 IR
300 IR grass pollen allergen extract tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
DRUGPlacebo
Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over 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
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. 2. Positive SPT to grasses 3. Total symptoms score for the previous pollen season more than 12 out of 18. 4. Patients with FEV1 ≥ 80% of the predicted value.
Exclusion criteria
1. Positive SPT to other grasses present during the grass pollen season and if endemic to the region 2. Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season 3. Asthma requiring treatment with medications other than beta-2 inhaled agonists. 4. Patients who have received any desensitization treatment for grass pollen in the past 5 years. 5. Ongoing immunotherapy with any other allergen. 6. Patients with any nasal or oral condition that could confound the efficacy or safety assessments 7. Patients with known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as lactose intolerance). 8. Patients with any past or current clinically significant condition which as judged by the investigator, may affect the patient's participation or the outcome of the study. 9. Patients treated with systemic or inhaled corticosteroids 10. Patients treated or under treatment with beta-blockers, continuous systemic corticotherapy or immunosuppressive drugs. 11. Pregnant, breastfeeding, or sexually active women who are not using a medically accepted contraceptive method as listed above. 12. Patients participating or having participated within 30 days before Screening in any clinical study. 13. Patients who are unlikely to complete the study for any reason, or patients who have to travel for extended periods of time during the grass pollen season which will compromise the data 14. Patients with history of drug or alcohol abuse. 15. Study staff, investigators, sub-investigators, as well as their children or spouses and family members of all study staff should not be enrolled in the study. 16. Patients will not be randomized in this study more than once.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined Score (CS) | Pollen period (average of 42.8 days) | 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. |
Countries
United States
Participant flow
Recruitment details
First Patient First Visit 22 OCT 2008, Last Patient Last Visit 13 AUG 2009
Participants by arm
| Arm | Count |
|---|---|
| 300 IR 300 IR grass pollen allergen extract tablet | 210 |
| Placebo Placebo tablet | 228 |
| Total | 438 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 15 | 2 |
| Overall Study | Any other reason not above-mentioned | 7 | 9 |
| Overall Study | Withdrawal by Subject | 4 | 6 |
Baseline characteristics
| Characteristic | 300 IR | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 36.8 years STANDARD_DEVIATION 11.27 | 37.6 years STANDARD_DEVIATION 11.64 | 37.2 years STANDARD_DEVIATION 11.46 |
| Sex: Female, Male Female | 109 Participants | 125 Participants | 234 Participants |
| Sex: Female, Male Male | 101 Participants | 103 Participants | 204 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 161 / 233 | 114 / 240 |
| serious Total, serious adverse events | 2 / 233 | 2 / 240 |
Outcome results
Primary
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 42.8 days)
Population: The Full Analysis Set (FAS) includes all patients who received at least one dose of the investigational product and had at least one Combined Score while on treatment during the pollen period. The FAS was regarded as primary for the efficacy evaluations.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 300 IR | Combined Score (CS) | 0.32 Units on a scale (range: 0 to 3) | Standard Error 0.033 |
| Placebo | Combined Score (CS) | 0.45 Units on a scale (range: 0 to 3) | Standard Error 0.032 |
p-value: 0.000395% CI: [-0.194, -0.058]ANCOVA