Allergy
Conditions
Keywords
Allergic rhinoconjunctivitis, Adults, Grass
Brief summary
This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS) The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS. The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.
Detailed description
This trial is a 2 year, parallel-group, double-blind, placebo-controlled phase III trial to evaluate efficacy and safety of the 5-grass mix SLIT-drops in adults with grass pollen-induced rhinoconjunctivitis with or without asthma. Approximately 440 adults will be enrolled in the trial and will receive the 5-grass mix SLIT-drops or placebo. The trial is conducted in several European countries.
Interventions
DRUG5-grass mix SLIT-drops
Sublingual allergy immunotherapy drops, for daily administration
DRUGPlacebo
Placebo
Sponsors
Syneos Health
ALK-Abelló A/S
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 No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female aged ≥18 years on the day informed consent is obtained 2. A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma 3. A clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season 4. Positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kU/l) against grass: Phleum pratense 5. Positive skin prick test to Phleum pratense at screening
Exclusion criteria
1. Has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods 2. Within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids 3. SLIT treatment with any grass pollen AIT for more than 1 month within the last 5 years. In addition, any SLIT treatment with grass pollen AIT within the previous 12 months 4. SCIT treatment with any grass AIT reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with grass AIT within the previous 12 months 5. Ongoing treatment with any allergy immunotherapy product 6. Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS) | During the 2nd PGPS (14 days) | The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS) | During the 1st PGPS (14 days) | The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS. |
| Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS) | During the 1st PGPS (14 days) | The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st PGPS. |
| Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS) | During the 1st EGPS (observed mean duration of approximately 8 weeks) | The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st EGPS. |
| Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS) | During the 2nd EGPS (observed mean duration of approximately 9 weeks) | The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd EGPS. |
| Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS) | During the 1st EGPS (observed mean duration of approximately 8 weeks) | The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS. |
| Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS) | During the 2nd EGPS (observed mean duration of approximately 9 weeks) | The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS. |
| Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS) | During the 1st PGPS (14 days) | The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS. |
| Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS) | During the 2nd PGPS (14 days) | The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd PGPS. |
| Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS) | During the 1st EGPS (observed mean duration of approximately 8 weeks) | The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS. |
| Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS) | During the 2nd EGPS (observed mean duration of approximately 9 weeks) | The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS. |
| Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS) | During the 1st PGPS (14 days) | The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS. |
| Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS) | During the 2nd PGPS (14 days) | The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale of 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS. |
| Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS) | During the 1st EGPS (observed mean duration of approximately 8 weeks) | The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication(on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS. |
| Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS) | During the 2nd EGPS (observed mean duration of approximately 9 weeks) | The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS. |
| Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS) | During the 2nd PGPS (14 days) | The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS. |
Countries
Czechia, Estonia, France, Latvia, Lithuania, Poland
Participant flow
Recruitment details
445 participants were randomized and treated. Participants were recruited from 45 sites in 6 countries (Czechia, Estonia, France, Latvia, Lithuania, and Poland).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Daily placebo sublingual immunotherapy drops (Placebo SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | 223 |
| 5-grass Mix SLIT-drops Daily grass sublingual immunotherapy drops (5-grass mix SLIT-drops) plus rhinoconjunctivitis rescue medication as needed. | 222 |
| Total | 445 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 4 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Reason stated as other in CRF | 1 | 2 |
| Overall Study | Withdrawal by Subject | 19 | 19 |
Baseline characteristics
| Characteristic | Placebo | 5-grass Mix SLIT-drops | Total |
|---|---|---|---|
| Age, Continuous | 33.0 Years STANDARD_DEVIATION 9.7 | 32.2 Years STANDARD_DEVIATION 10.1 | 32.6 Years STANDARD_DEVIATION 9.9 |
| Ongoing asthma | 63 Participants | 59 Participants | 122 Participants |
| Race/Ethnicity, Customized White | 223 Participants | 222 Participants | 445 Participants |
| Region of Enrollment Czechia | 56 participants | 57 participants | 113 participants |
| Region of Enrollment Estonia | 2 participants | 0 participants | 2 participants |
| Region of Enrollment France | 6 participants | 7 participants | 13 participants |
| Region of Enrollment Latvia | 17 participants | 16 participants | 33 participants |
| Region of Enrollment Lithuania | 25 participants | 26 participants | 51 participants |
| Region of Enrollment Poland | 117 participants | 116 participants | 233 participants |
| Sex: Female, Male Female | 105 Participants | 95 Participants | 200 Participants |
| Sex: Female, Male Male | 118 Participants | 127 Participants | 245 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 223 | 0 / 222 |
| other Total, other adverse events | 111 / 223 | 128 / 222 |
| serious Total, serious adverse events | 6 / 223 | 4 / 222 |
Outcome results
Primary
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Time frame: During the 2nd PGPS (14 days)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS) | 7.10 score on a scale | Standard Error 0.51 |
| 5-grass Mix SLIT-drops | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS) | 5.22 score on a scale | Standard Error 0.42 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 86% power for the primary endpoint using the primary (trial product) estimand.p-value: 0.003695% CI: [0.6, 3.17]Mixed Models Analysis
Secondary
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication(on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS) | 3.04 score on a scale | Standard Error 0.35 |
| 5-grass Mix SLIT-drops | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS) | 2.10 score on a scale | Standard Error 0.27 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.005495% CI: [0.25, 1.63]Mixed Models Analysis
Secondary
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Time frame: During the 1st PGPS (14 days)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS) | 3.34 units on a scale | Standard Error 0.34 |
| 5-grass Mix SLIT-drops | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS) | 2.23 units on a scale | Standard Error 0.25 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.004995% CI: [0.3, 1.93]Mixed Models Analysis
Secondary
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS) | 2.62 score on a scale | Standard Error 0.31 |
| 5-grass Mix SLIT-drops | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS) | 1.51 score on a scale | Standard Error 0.23 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.000295% CI: [0.52, 1.71]Mixed Models Analysis
Secondary
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale of 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Time frame: During the 2nd PGPS (14 days)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS) | 2.77 score on a scale | Standard Error 0.3 |
| 5-grass Mix SLIT-drops | Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS) | 1.52 score on a scale | Standard Error 0.21 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.000495% CI: [0.54, 1.95]Mixed Models Analysis
Secondary
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS) | 3.82 score on a scale | Standard Error 0.24 |
| 5-grass Mix SLIT-drops | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS) | 3.61 score on a scale | Standard Error 0.22 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.460495% CI: [-0.37, 0.79]Mixed Models Analysis
Secondary
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Time frame: During the 1st PGPS (14 days)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS) | 4.08 score on a scale | Standard Error 0.27 |
| 5-grass Mix SLIT-drops | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS) | 3.83 score on a scale | Standard Error 0.23 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.450295% CI: [-0.42, 0.92]Mixed Models Analysis
Secondary
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS) | 3.46 score on a scale | Standard Error 0.23 |
| 5-grass Mix SLIT-drops | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS) | 2.89 score on a scale | Standard Error 0.22 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.054995% CI: [-0.01, 1.15]Mixed Models Analysis
Secondary
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Time frame: During the 2nd PGPS (14 days)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS) | 3.64 score on a scale | Standard Error 0.26 |
| 5-grass Mix SLIT-drops | Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS) | 3.09 score on a scale | Standard Error 0.25 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.117795% CI: [-0.14, 1.23]Mixed Models Analysis
Secondary
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS) | 7.42 score on a scale | Standard Error 0.54 |
| 5-grass Mix SLIT-drops | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS) | 6.23 score on a scale | Standard Error 0.45 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand..p-value: 0.032995% CI: [0.06, 2.31]Mixed Models Analysis
Secondary
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Time frame: During the 1st PGPS (14 days)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS) | 8.10 score on a scale | Standard Error 0.54 |
| 5-grass Mix SLIT-drops | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS) | 6.76 score on a scale | Standard Error 0.42 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.041795% CI: [-0.01, 2.67]Mixed Models Analysis
Secondary
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS) | 6.58 score on a scale | Standard Error 0.5 |
| 5-grass Mix SLIT-drops | Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS) | 4.86 score on a scale | Standard Error 0.43 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.001695% CI: [0.66, 2.79]Mixed Models Analysis
Secondary
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st EGPS.
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS) | 1.16 score on a scale | Standard Error 0.09 |
| 5-grass Mix SLIT-drops | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS) | 1.09 score on a scale | Standard Error 0.08 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.443895% CI: [-0.12, 0.27]Mixed Models Analysis
Secondary
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st PGPS.
Time frame: During the 1st PGPS (14 days)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS) | 1.26 score on a scale | Standard Error 0.09 |
| 5-grass Mix SLIT-drops | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS) | 1.19 score on a scale | Standard Error 0.08 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.498495% CI: [-0.15, 0.3]Mixed Models Analysis
Secondary
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd EGPS.
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS) | 1.03 score on a scale | Standard Error 0.08 |
| 5-grass Mix SLIT-drops | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS) | 0.83 score on a scale | Standard Error 0.07 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.p-value: 0.036395% CI: [0.01, 0.38]Mixed Models Analysis
Secondary
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd PGPS.
Time frame: During the 2nd PGPS (14 days)
Population: Participants in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS) | 1.04 score on a scale | Standard Error 0.08 |
| 5-grass Mix SLIT-drops | Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS) | 0.86 score on a scale | Standard Error 0.08 |
Comparison: The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 95% power for this key secondary endpoint using the primary (trial product) estimand.p-value: 0.111195% CI: [-0.04, 0.39]Mixed Models Analysis