A Phase 3 interventional study of Tree SLIT-tablet and Placebo SLIT-tablet in Allergy, sponsored by ALK-Abelló A/S. Completed at 80 sites in 11 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by ALK-Abelló A/S · Phase 3, Interventional, and Treatment
This is a clinical study in children and adolescents (5-17 years) with allergy to pollen from birch (or related trees). It compares the tree SLIT-tablet with placebo in relieving rhinoconjunctivitis symptoms during the birch/tree pollen season based on the average allergic rhinoconjunctivitis daily total combined score.
The study will also collect health-related quality of life information in the groups treated with the tree SLIT-tablet or with placebo during the pollen season.
The trial medication used is already approved to treat allergic rhinitis caused by birch/tree pollen in adults in several countries?.
This is a phase III, parallel-group, double-blind, placebo-controlled study to evaluate efficacy and safety of the tree SLIT-tablet in children and adolescents (5-17 years) who have rhinoconjunctivitis (with or without asthma) induced by pollen from birch trees or by trees belonging to the birch homologous group. Approximately 1000 children and adolescents will be enrolled in the trial and will receive either the tree SLIT-tablet or placebo.
The trial consists of 3 periods: a screening period, a treatment period, which includes pre-seasonal and co seasonal treatment, and a follow-up period. The duration is up to 13 months for each participant.
The trial is conducted in several European countries and in Canada.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's enrollment of 952 is above the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →ALK-Abelló A/S is the lead sponsor of 67 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of 1 or more of the following Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to AR/C during the previous BPS:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gelatine (fish source), mannitol and sodium hydroxide
Drug: Placebo SLIT-tablet
Sublingual allergy immunotherapy tablet, for daily administration SQ tree SLIT-tablet
Drug: Tree SLIT-tablet
Sublingual allergy immunotherapy tablets
Placebo
Average Total Combined Score (TCS) During the Birch Pollen Season (BPS)
The primary endpoint of the trial was the average allergic rhinitis and/or conjunctivitis TCS during the BPS. The average TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). 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 BPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the BPS (mean duration of approximately 3-4 weeks)
Average Total Combined Score (TCS) During the Tree Pollen Season (TPS)
Average TCS measured in the TPS. TPS includes hazel, alder, birch and oak pollen seasons. The average TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). 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 TPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the TPS (mean duration of approximately 11 weeks)
Average Daily Symptoms Score (DSS) During the Birch Pollen Season (BPS)
Average rhinoconjunctivitis DSS during the BPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the BPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the BPS (mean duration of approximately 3-4 weeks)
Average Daily Symptoms Score (DSS) During the Tree Pollen Season (TPS)
Average rhinoconjunctivitis DSS during the TPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). TPS includes hazel, alder, birch and oak pollen seasons. Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the TPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the TPS (mean duration of approximately 11 weeks).
Average Daily Medication Score (DMS) During the Birch Pollen Season (BPS)
Average rhinoconjunctivitis DMS during the BPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (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 BPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the BPS (mean duration of approximately 3-4 weeks)
Average Daily Medication Score (DMS) During the Tree Pollen Season (TPS)
Average rhinoconjunctivitis DMS during the TPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0 to 20). TPS includes hazel, alder, birch and oak pollen seasons. Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the TPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the TPS (mean duration of approximately 11 weeks)
Average Total Combined Score (TCS) During the Alder Hazel Pollen Season (AHPS)
Average TCS during the AHPS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). 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 AHPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the AHPS (mean duration of approximately 6-7 weeks)
Average Daily Symptoms Score (DSS) During the Alder Hazel Pollen Season (AHPS)
Average rhinoconjunctivitis DSS during the AHPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the AHPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the AHPS (mean duration of approximately 6-7 weeks)
Average Daily Medication Score (DMS) During the Alder Hazel Pollen Season (AHPS)
Average rhinoconjunctivitis DMS during the AHPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (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 AHPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the AHPS (mean duration of approximately 6-7 weeks)
Average Total Combined Score (TCS) During the Oak Pollen Season (OPS)
Average TCS measured in the OPS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). 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 OPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the OPS (mean duration of approximately 3 weeks)
Average Daily Symptoms Score (DSS) During the Oak Pollen Season (OPS)
Average rhinoconjunctivitis DSS during the OPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the OPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the OPS (mean duration of approximately 3 weeks)
Average Daily Medication Score (DMS) During the Oak Pollen Season (OPS)
Average rhinoconjunctivitis DMS during the OPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (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 OPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the OPS (mean duration of approximately 3 weeks)
Number of Severe Days During the Birch Pollen Season (BPS)
The disease burden for participants was analyzed in terms of proportion of severe days. A severe day was a day with a daily symptom score (DSS) ≥6 and ≥2 moderate symptoms or 1 severe symptom. The DSS ranged from 0 to 18 and was the sum of the 6 allergic rhinoconjunctivitis symptom scores, each scored on a scale from 0 to 3 (0 = no symptoms, 1= mild symptoms, 2= moderate symptoms and 3 = severe symptoms). The proportion of severe days was the number of severe days divided by the number of days in the season.
Time frame: During the BPS (mean duration of approximately 3-4 weeks)
Number of Severe Days During the Tree Pollen Season (TPS)
The disease burden for participants was analyzed in terms of proportion of severe days. A severe day was a day with a daily symptom score (DSS) ≥6 and ≥2 moderate symptoms or 1 severe symptom. The DSS ranged from 0 to 18 and was the sum of the 6 allergic rhinoconjunctivitis symptom scores, each scored on a scale from 0 to 3 (0 = no symptoms, 1= mild symptoms, 2= moderate symptoms and 3 = severe symptoms). The proportion of severe days was the number of severe days divided by the number of days in the season.
Time frame: During the TPS (mean duration of approximately 11 weeks)
Number of Well Days During the Birch Pollen Season (BPS)
A well day was defined as a day with no use of allergic rhinitis and/or conjunctivitis (AR/C) rescue medication (daily medication score =0) and daily symptom score ≤2. The proportion of well days was the number of well days divided by the number of days in the season.
Time frame: During the BPS (mean duration of approximately 3-4 weeks)
Number of Well Days During the Tree Pollen Season (TPS)
A well day was defined as a day with no use of allergic rhinitis and/or conjunctivitis (AR/C) rescue medication (daily medication score =0) and daily symptom score ≤2. The proportion of well days was the number of well days divided by the number of days in the season.
Time frame: During the TPS (mean duration of approximately 11 weeks)
Number of Symptom-free Days During the Birch Pollen Season (BPS)
A a symptom-free day was defined as a day with no symptoms and with no use of rescue medication (Total Combined Score = 0). The proportion of symptom-free days was the number of symptom-free divided by the number of days in the season.
Time frame: During the BPS (mean duration of approximately 3-4 weeks)
Number of Symptom-free Days During the Tree Pollen Season (TPS)
A a symptom-free day was defined as a day with no symptoms and with no use of rescue medication (Total Combined Score = 0). The proportion of symptom-free days was the number of symptom-free divided by the number of days in the season.
Time frame: During the TPS (mean duration of approximately 11 weeks)
Percentage of Patients Free of Symptoms and With no Use of Rescue Medication During the Birch Pollen Season (BPS)
A symptom-free day was defined as a day with no symptoms and with no use of rescue medication, i.e. total combined score (TCS) =0. Thus, the endpoint was categorized as a binary variable with a subject being a responder if he/she had no symptoms and had not used rescue medication during the season
Time frame: During the BPS (mean duration of approximately 3-4 weeks)
Percentage of Patients Free of Symptoms and With no Use of Rescue Medication During the Tree Pollen Season (TPS)
A symptom-free day was defined as a day with no symptoms and with no use of rescue medication, i.e. total combined score (TCS) = 0. Thus, the endpoint was categorized as a binary variable with a subject being a responder if he/she had no symptoms and had not used rescue medication during the tree pollen season.
Time frame: During the TPS (mean duration of approximately 11 weeks)
Average Total Combined Score (TCS) (EAACI Scoring) During Birch Pollen Season (BPS)
The TCS European Academy of Allergy and Clinical Immunology (EAACI) scoring was calculated using the medication score proposed by EAACI and was the sum of the DSS/6 and the daily EAACI medication score (DMSEAACI) (values 0,1,2), and thus ranged 0-5 with higher scores indicating more combined allergy symptoms and medication use. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the BPS (mean duration of approximately 3-4 weeks)
Average Total Combined Score (TCS) (EAACI Scoring) During Tree Pollen Season (TPS)
The TCS European Academy of Allergy and Clinical Immunology (EAACI) scoring was calculated using the medication score proposed by EAACI and was the sum of the DSS/6 and the daily EAACI medication score (DMSEAACI) (values 0,1,2), and thus ranged 0-5 with higher scores indicating more combined allergy symptoms and medication use. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the TPS (mean duration of approximately 11 weeks).
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Birch Pollen Season (BPS) (12-17 Years Only)
The RQLQ measured the rhinoconjunctivitis quality of life. The RQLQ (for participants 12-17 years only) comprised 28 items, each scored on a 7-point scale ranging 0-6, with higher scores indicating worse quality of life. The overall RQLQ score was the mean of the 28 item scores. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the BPS (mean duration of approximately 3-4 weeks)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Tree Pollen Season (TPS) (12-17 Years Only)
The RQLQ measured the rhinoconjunctivitis quality of life. The RQLQ (for participants 12-17 years only) comprised 28 items, each scored on a 7-point scale ranging 0-6, with higher scores indicating worse quality of life. The overall RQLQ score was the mean of the 28 item scores. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the TPS (mean duration of approximately 11 weeks)
Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score During the Birch Pollen Season (BPS) (5-11 Years Only)
The PRQLQ measured the paediatric rhinoconjunctivitis quality of life. The PRQLQ consisted of 23 items, each scored on a 7-point scale ranging 0-6, with higher scores indicating worse quality of life. The overall PRQLQ score was the mean of the 23 item scores. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: During the BPS (mean duration of approximately 3-4 weeks)
Treatment Satisfaction (TSQM-9)
Treatment satisfaction was measured using the 9-item treatment satisfaction questionnaire for medication (TSQM-9 questionnaire). After ending treatment, participants completed the TSQM-9 questionnaire which consisted of 9 items covering 3 domains. Each item was scored on a 5 point (ranging 1-5) or 7 point (ranging 1-7) scale. For each domain, item scores were summed and normalised to a 0-100 scale, with higher scores indicating better satisfaction.
Time frame: After ending treatment (after approximately 52 weeks of treatment)
Patient-rated Global Evaluation of Treatment Efficacy
The global evaluation measured patient treatment satisfaction. After ending treatment, participants were asked: 'Compared to your rhinitis and/or conjunctivitis symptoms in the previous birch/tree pollen season, how have you felt overall in this birch/tree pollen season?'. The endpoint was evaluated as a binary endpoint; answer options 'much better' and 'better' were categorised as improved (taking value 1), while answer options 'the same', 'worse', and 'much worse' were categorised as not improved (taking value 0). The primary estimand for the endpoint was he trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
Time frame: End of treatment (after approximately 52 weeks of treatment)
Change From Baseline in Birch Specific IgE
Birch specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation
Time frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change From Baseline in Birch Specific IgG4
Birch specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation.
Time frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change From Baseline in Birch Specific IgE-Blocking Factor (IgE-BF)
The IgE-blocking factor assesses the effect of serum components (including IgE-blocking antibodies known to be induced by allergy immunotherapy) competing with IgE for binding to allergen. IgE-blocking factor is calculated as 1-(S/T), where S is the amount of allergen-specific IgE bound to allergen in the (possible) presence of competing components, and where T is the total amount of allergen-specific IgE capable of binding to allergen when all competing antibodies/components have been washed off. IgE-blocking factor values closer to 0 indicate the presence of fewer IgE-blocking components and values closer to 1 indicate that more IgE is blocked from binding to the allergen.
Time frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change From Baseline in Alder, Hazel and Oak Specific IgE
Change in alder, hazel and oak specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation.
Time frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change From Baseline in Alder, Hazel and Oak Specific IgG4
Change in alder, hazel and oak specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation.
Time frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change From Baseline in Alder and Hazel Specific IgE- Blocking Factor (IgE-BF)
The IgE-blocking factor assesses the effect of serum components (including IgE-blocking antibodies known to be induced by allergy immunotherapy) competing with IgE for binding to allergen. IgE-blocking factor is calculated as 1-(S/T), where S is the amount of allergen-specific IgE bound to allergen in the (possible) presence of competing components, and where T is the total amount of allergen-specific IgE capable of binding to allergen when all competing antibodies/components have been washed off. IgE-blocking factor values closer to 0 indicate the presence of fewer IgE-blocking components and values closer to 1 indicate that more IgE is blocked from binding to the allergen.
Time frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks treatment, on average)
952 participants were randomized and treated. Participants were recruited from 80 sites in 11 countries (Austria, Belgium, Canada, Denmark, Germany, Hungary, Lithuania, Netherlands, Poland, Russia and Slovakia). First participant first visit: 08-Apr-2021. Last participant last visit/contact: 31-Jul-2023.
| Milestone | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Started | 479 | 473 |
| Completed trial | 458 | 456 |
| Full analysis set | 479 | 473 |
| Safety analysis set | 479 | 473 |
| Subgroup analysis set | 132 | 119 |
| Completed | 454 | 443 |
| Not completed | 25 | 30 |
| Withdrew: Adverse event | 4 | 13 |
| Withdrew: Withdrawal by subject | 14 | 12 |
| Withdrew: Lost to follow-up | 4 | 1 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Reason stated as "other" in crf | 2 | 3 |
The primary endpoint of the trial was the average allergic rhinitis and/or conjunctivitis TCS during the BPS. The average TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). 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 BPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Total Combined Score (TCS) During the Birch Pollen Season (BPS) | 5.88 ± 0.33 | 4.60 ± 0.29 |
Average TCS measured in the TPS. TPS includes hazel, alder, birch and oak pollen seasons. The average TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). 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 TPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Total Combined Score (TCS) During the Tree Pollen Season (TPS) | 4.51 ± 0.25 | 3.66 ± 0.22 |
Average rhinoconjunctivitis DSS during the BPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the BPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Daily Symptoms Score (DSS) During the Birch Pollen Season (BPS) | 2.75 ± 0.16 | 2.39 ± 0.15 |
Average rhinoconjunctivitis DSS during the TPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). TPS includes hazel, alder, birch and oak pollen seasons. Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the TPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Daily Symptoms Score (DSS) During the Tree Pollen Season (TPS) | 2.28 ± 0.14 | 2.04 ± 0.13 |
Average rhinoconjunctivitis DMS during the BPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (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 BPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Daily Medication Score (DMS) During the Birch Pollen Season (BPS) | 2.42 ± 0.23 | 1.55 ± 0.18 |
Average rhinoconjunctivitis DMS during the TPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0 to 20). TPS includes hazel, alder, birch and oak pollen seasons. Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the TPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Daily Medication Score (DMS) During the Tree Pollen Season (TPS) | 1.72 ± 0.16 | 1.18 ± 0.13 |
Average TCS during the AHPS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). 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 AHPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Total Combined Score (TCS) During the Alder Hazel Pollen Season (AHPS) | 2.83 ± 0.22 | 2.51 ± 0.21 |
Average rhinoconjunctivitis DSS during the AHPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the AHPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Daily Symptoms Score (DSS) During the Alder Hazel Pollen Season (AHPS) | 1.57 ± 0.12 | 1.56 ± 0.13 |
Average rhinoconjunctivitis DMS during the AHPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (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 AHPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Daily Medication Score (DMS) During the Alder Hazel Pollen Season (AHPS) | 0.80 ± 0.11 | 0.59 ± 0.09 |
Average TCS measured in the OPS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). 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 OPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Total Combined Score (TCS) During the Oak Pollen Season (OPS) | 5.67 ± 0.36 | 4.22 ± 0.31 |
Average rhinoconjunctivitis DSS during the OPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the OPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Daily Symptoms Score (DSS) During the Oak Pollen Season (OPS) | 2.68 ± 0.16 | 2.20 ± 0.15 |
Average rhinoconjunctivitis DMS during the OPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (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 OPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Daily Medication Score (DMS) During the Oak Pollen Season (OPS) | 2.18 ± 0.23 | 1.31 ± 0.18 |
The disease burden for participants was analyzed in terms of proportion of severe days. A severe day was a day with a daily symptom score (DSS) ≥6 and ≥2 moderate symptoms or 1 severe symptom. The DSS ranged from 0 to 18 and was the sum of the 6 allergic rhinoconjunctivitis symptom scores, each scored on a scale from 0 to 3 (0 = no symptoms, 1= mild symptoms, 2= moderate symptoms and 3 = severe symptoms). The proportion of severe days was the number of severe days divided by the number of days in the season.
| Proportion of severe days | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Number of Severe Days During the Birch Pollen Season (BPS) | 0.23 | 0.20 |
The disease burden for participants was analyzed in terms of proportion of severe days. A severe day was a day with a daily symptom score (DSS) ≥6 and ≥2 moderate symptoms or 1 severe symptom. The DSS ranged from 0 to 18 and was the sum of the 6 allergic rhinoconjunctivitis symptom scores, each scored on a scale from 0 to 3 (0 = no symptoms, 1= mild symptoms, 2= moderate symptoms and 3 = severe symptoms). The proportion of severe days was the number of severe days divided by the number of days in the season.
| Proportion of severe days | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Number of Severe Days During the Tree Pollen Season (TPS) | 0.11 | 0.11 |
A well day was defined as a day with no use of allergic rhinitis and/or conjunctivitis (AR/C) rescue medication (daily medication score =0) and daily symptom score ≤2. The proportion of well days was the number of well days divided by the number of days in the season.
| Proportion of well days | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Number of Well Days During the Birch Pollen Season (BPS) | 0.36 | 0.43 |
A well day was defined as a day with no use of allergic rhinitis and/or conjunctivitis (AR/C) rescue medication (daily medication score =0) and daily symptom score ≤2. The proportion of well days was the number of well days divided by the number of days in the season.
| Proportion of well days | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Number of Well Days During the Tree Pollen Season (TPS) | 0.50 | 0.53 |
A a symptom-free day was defined as a day with no symptoms and with no use of rescue medication (Total Combined Score = 0). The proportion of symptom-free days was the number of symptom-free divided by the number of days in the season.
| Proportion of symptom-free days | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Number of Symptom-free Days During the Birch Pollen Season (BPS) | 0.24 | 0.29 |
A a symptom-free day was defined as a day with no symptoms and with no use of rescue medication (Total Combined Score = 0). The proportion of symptom-free days was the number of symptom-free divided by the number of days in the season.
| Proportion of symptom-free days | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Number of Symptom-free Days During the Tree Pollen Season (TPS) | 0.28 | 0.30 |
A symptom-free day was defined as a day with no symptoms and with no use of rescue medication, i.e. total combined score (TCS) =0. Thus, the endpoint was categorized as a binary variable with a subject being a responder if he/she had no symptoms and had not used rescue medication during the season
| Participants | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| No season data | 19 | 18 |
| TCS=0 all days | 21 | 20 |
| TCS> 0 any day | 439 | 435 |
A symptom-free day was defined as a day with no symptoms and with no use of rescue medication, i.e. total combined score (TCS) = 0. Thus, the endpoint was categorized as a binary variable with a subject being a responder if he/she had no symptoms and had not used rescue medication during the tree pollen season.
| Participants | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| No season data | 15 | 16 |
| TCS = 0 all days | 10 | 4 |
| TCS > 0 any day | 454 | 453 |
The TCS European Academy of Allergy and Clinical Immunology (EAACI) scoring was calculated using the medication score proposed by EAACI and was the sum of the DSS/6 and the daily EAACI medication score (DMSEAACI) (values 0,1,2), and thus ranged 0-5 with higher scores indicating more combined allergy symptoms and medication use. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Total Combined Score (TCS) (EAACI Scoring) During Birch Pollen Season (BPS) | 0.95 ± 0.05 | 0.77 ± 0.05 |
The TCS European Academy of Allergy and Clinical Immunology (EAACI) scoring was calculated using the medication score proposed by EAACI and was the sum of the DSS/6 and the daily EAACI medication score (DMSEAACI) (values 0,1,2), and thus ranged 0-5 with higher scores indicating more combined allergy symptoms and medication use. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Total Combined Score (TCS) (EAACI Scoring) During Tree Pollen Season (TPS) | 0.74 ± 0.04 | 0.62 ± 0.04 |
The RQLQ measured the rhinoconjunctivitis quality of life. The RQLQ (for participants 12-17 years only) comprised 28 items, each scored on a 7-point scale ranging 0-6, with higher scores indicating worse quality of life. The overall RQLQ score was the mean of the 28 item scores. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Birch Pollen Season (BPS) (12-17 Years Only) | 0.98 ± 0.09 | 0.97 ± 0.09 |
The RQLQ measured the rhinoconjunctivitis quality of life. The RQLQ (for participants 12-17 years only) comprised 28 items, each scored on a 7-point scale ranging 0-6, with higher scores indicating worse quality of life. The overall RQLQ score was the mean of the 28 item scores. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Tree Pollen Season (TPS) (12-17 Years Only) | 0.85 ± 0.07 | 0.86 ± 0.08 |
The PRQLQ measured the paediatric rhinoconjunctivitis quality of life. The PRQLQ consisted of 23 items, each scored on a 7-point scale ranging 0-6, with higher scores indicating worse quality of life. The overall PRQLQ score was the mean of the 23 item scores. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score During the Birch Pollen Season (BPS) (5-11 Years Only) | 1.30 ± 0.07 | 1.12 ± 0.07 |
Treatment satisfaction was measured using the 9-item treatment satisfaction questionnaire for medication (TSQM-9 questionnaire). After ending treatment, participants completed the TSQM-9 questionnaire which consisted of 9 items covering 3 domains. Each item was scored on a 5 point (ranging 1-5) or 7 point (ranging 1-7) scale. For each domain, item scores were summed and normalised to a 0-100 scale, with higher scores indicating better satisfaction.
| score on a scale | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Convenience | 79.6 ± 14.7 | 78.2 ± 15.3 |
| Effectiveness | 59.8 ± 21.1 | 67.6 ± 18.4 |
| Global satisfaction | 62.1 ± 23.5 | 69.9 ± 20.0 |
The global evaluation measured patient treatment satisfaction. After ending treatment, participants were asked: 'Compared to your rhinitis and/or conjunctivitis symptoms in the previous birch/tree pollen season, how have you felt overall in this birch/tree pollen season?'. The endpoint was evaluated as a binary endpoint; answer options 'much better' and 'better' were categorised as improved (taking value 1), while answer options 'the same', 'worse', and 'much worse' were categorised as not improved (taking value 0). The primary estimand for the endpoint was he trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
| Proportion | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Patient-rated Global Evaluation of Treatment Efficacy | 0.70 (0.65 to 0.74) | 0.85 (0.81 to 0.88) |
Birch specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation
| Log10 transformed kU/L | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Birch specific IgE, visit 4 | -0.21 (-0.24 to -0.18) | 0.22 (0.18 to 0.26) |
| Birch specific IgE, visit 6 | 0.10 (0.07 to 0.13) | 0.06 (0.02 to 0.10) |
Birch specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation.
| Log10 transformed mg/L | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Birch specific IgG4, visit 4 | -0.09 (-0.11 to -0.07) | 0.43 (0.39 to 0.47) |
| Birch specific IgG4, visit 6 | 0.05 (0.03 to 0.07) | 0.54 (0.51 to 0.58) |
The IgE-blocking factor assesses the effect of serum components (including IgE-blocking antibodies known to be induced by allergy immunotherapy) competing with IgE for binding to allergen. IgE-blocking factor is calculated as 1-(S/T), where S is the amount of allergen-specific IgE bound to allergen in the (possible) presence of competing components, and where T is the total amount of allergen-specific IgE capable of binding to allergen when all competing antibodies/components have been washed off. IgE-blocking factor values closer to 0 indicate the presence of fewer IgE-blocking components and values closer to 1 indicate that more IgE is blocked from binding to the allergen.
| Unitless | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Birch specific IgE-BF, visit 4 | -0.01 (-0.03 to 0.01) | 0.28 (0.23 to 0.32) |
| Birch specific IgE-BF, visit 6 | 0.04 (0.02 to 0.05) | 0.35 (0.30 to 0.40) |
Change in alder, hazel and oak specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation.
| log10 transformed kU/L | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Alder specific IgE, visit 4 | -0.22 ± 0.20 | 0.17 ± 0.41 |
| Alder specific IgE, visit 6 | 0.18 ± 0.34 | 0.10 ± 0.31 |
| Hazel specific IgE, visit 4 | -0.22 ± 0.21 | 0.15 ± 0.38 |
| Hazel specific IgE, visit 6 | 0.20 ± 0.36 | 0.11 ± 0.30 |
| Oak specific IgE, visit 4 | -0.21 ± 0.17 | 0.14 ± 0.37 |
| Oak specific IgE, visit 6 | 0.20 ± 0.34 | 0.11 ± 0.29 |
Change in alder, hazel and oak specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation.
| log10 transformed mg/L | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Alder specific IgG4, visit 4 | -0.08 ± 0.18 | 0.38 ± 0.39 |
| Alder specific IgG4, visit 6 | 0.13 ± 0.26 | 0.51 ± 0.41 |
| Hazel specific IgG4, visit 4 | -0.08 ± 0.19 | 0.35 ± 0.39 |
| Hazel specific IgG4, visit 6 | 0.11 ± 0.24 | 0.46 ± 0.42 |
| Oak specific IgG4, visit 4 | -0.07 ± 0.14 | 0.28 ± 0.39 |
| Oak specific IgG4, visit 6 | 0.08 ± 0.21 | 0.32 ± 0.35 |
The IgE-blocking factor assesses the effect of serum components (including IgE-blocking antibodies known to be induced by allergy immunotherapy) competing with IgE for binding to allergen. IgE-blocking factor is calculated as 1-(S/T), where S is the amount of allergen-specific IgE bound to allergen in the (possible) presence of competing components, and where T is the total amount of allergen-specific IgE capable of binding to allergen when all competing antibodies/components have been washed off. IgE-blocking factor values closer to 0 indicate the presence of fewer IgE-blocking components and values closer to 1 indicate that more IgE is blocked from binding to the allergen.
| Unitless | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Alder specific IgE-BF, visit 4 | -0.03 ± 0.08 | 0.20 ± 0.18 |
| Alder specific IgE-BF, visit 6 | 0.04 ± 0.13 | 0.21 ± 0.19 |
| Hazel specific IgE-BF, visit 4 | -0.03 ± 0.08 | 0.15 ± 0.18 |
| Hazel specific IgE-BF, visit 6 | 0.02 ± 0.10 | 0.14 ± 0.17 |
Collected over All AEs with start date/time on or after the time of first IMP administration and no later than 7 days after last IMP administration (up to approximately 12 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo SLIT-tablet | 0/479 (0%) | 6/479 (1.3%) | 194/479 (40.5%) |
| Tree SLIT-tablet | 0/473 (0%) | 5/473 (1.1%) | 315/473 (66.6%) |
| Event | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| GastroenteritisInfections and infestations | 0/479 | 1/473 |
| ImpetigoInfections and infestations | 0/479 | 1/473 |
| Infectious mononucleosisInfections and infestations | 0/479 | 1/473 |
| Anaphylactic reactionImmune system disorders | 0/479 | 1/473 |
| Foot operationSurgical and medical procedures | 0/479 | 1/473 |
| AppendicitisInfections and infestations | 1/479 | 0/473 |
| Lymph node abscessInfections and infestations | 1/479 | 0/473 |
| Peritonsillar abscessInfections and infestations | 1/479 | 0/473 |
| TonsillitisInfections and infestations | 1/479 | 0/473 |
| LymphadenitisBlood and lymphatic system disorders | 1/479 | 0/473 |
| Event | Placebo SLIT-tablet | Tree SLIT-tablet |
|---|---|---|
| Oral pruritusGastrointestinal disorders | 17/479 | 114/473 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 18/479 | 112/473 |
| NasopharyngitisInfections and infestations | 82/479 | 81/473 |
| Tongue pruritusGastrointestinal disorders | 6/479 | 60/473 |
| Upper respiratory tract infectionInfections and infestations | 43/479 | 42/473 |
| COVID-19Infections and infestations | 43/479 | 27/473 |
| PharyngitisInfections and infestations | 21/479 | 32/473 |
| Paraesthesia oralGastrointestinal disorders | 8/479 | 28/473 |
| InfluenzaInfections and infestations | 25/479 | 17/473 |
All randomized and treated participants
| Age, Categorical(Participants) | Placebo SLIT-tablet | Tree SLIT-tablet | Total |
|---|---|---|---|
| <=18 years | 479 | 473 | 952 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Placebo SLIT-tablet | Tree SLIT-tablet | Total |
|---|---|---|---|
| Mean | 10.2 ± 3.5 | 10.4 ± 3.5 | 10.3 ± 3.5 |
| Age, Customized(Participants) | Placebo SLIT-tablet | Tree SLIT-tablet | Total |
|---|---|---|---|
| Age by group — 5-11 years | 300 | 297 | 597 |
| Age by group — 12-17 years | 179 | 176 | 355 |
| Sex: Female, Male(Participants) | Placebo SLIT-tablet | Tree SLIT-tablet | Total |
|---|---|---|---|
| Female | 194 | 185 | 379 |
| Male | 285 | 288 | 573 |
| Ethnicity (NIH/OMB)(Participants) | Placebo SLIT-tablet | Tree SLIT-tablet | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 3 | 8 |
| Not Hispanic or Latino | 471 | 463 | 934 |
| Unknown or Not Reported | 3 | 7 | 10 |
| Race/Ethnicity, Customized(Participants) | Placebo SLIT-tablet | Tree SLIT-tablet | Total |
|---|---|---|---|
| Asian | 4 | 1 | 5 |
| White | 473 | 468 | 941 |
| Black or African American | 0 | 1 | 1 |
| Multiple | 2 | 2 | 4 |
| Other | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Placebo SLIT-tablet | Tree SLIT-tablet | Total |
|---|---|---|---|
| Canada | 42 | 45 | 87 |
| Austria | 4 | 6 | 10 |
| Netherlands | 2 | 0 | 2 |
| Belgium | 3 | 4 | 7 |
| Hungary | 24 | 21 | 45 |
| Denmark | 10 | 8 | 18 |
| Poland | 225 | 221 | 446 |
| Slovakia | 40 | 39 | 79 |
| Lithuania | 46 | 46 | 92 |
| Germany | 44 | 45 | 89 |
| Russia | 39 | 38 | 77 |
| Allergic condition caused by birch(participants) | Placebo SLIT-tablet | Tree SLIT-tablet | Total |
|---|---|---|---|
| Allergic conjunctivitis | 4 | 2 | 6 |
| Allergic rhinitis | 122 | 125 | 247 |
| Allergic rhinoconjunctivitis | 353 | 346 | 699 |
| Asthma | 125 | 126 | 251 |
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