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The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.
To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:
- The Average Adjusted Symptom Score (AASS).
To document the safety of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300 IR | Experimental | 300 IR grass pollen allergen extract tablet |
|
| Placebo | Placebo Comparator | Placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300 IR | Drug | 300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Adjusted Symptom Score (AAdSS) | The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome. | Pollen period (average of 32.1 days) |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DE BLAY Frédéric, MD | NHC, Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stallergenes Sa | Antony | 92183 | France | |||
| Hop Montauban |
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First Patient First Visit 28 JAN 2009, Last Patient Last Visit 31 AUG 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | 300 IR | 300 IR grass pollen allergen extract tablet |
| FG001 | Placebo | Placebo tablet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Set: The Safety Set included all patients who received at least one dose of the investigational product.
The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score during the pollen period while on treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 300 IR | 300 IR grass pollen allergen extract tablet |
| BG001 | Placebo | Placebo tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Adjusted Symptom Score (AAdSS) | The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome. | The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score during the pollen period while on treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale (range: 0 to 18) | Pollen period (average of 32.1 days) |
2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 300 IR | 300 IR grass pollen allergen extract tablet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA Version 11.1. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ORAL PRURITUS | Gastrointestinal disorders | MedDRA Version 11.1. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laurence Paolozzi, Medical Director | Stallergenes | +33 (0) 1 55 59 26 33 | lpaolozzi@stallergenes.com |
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| ID | Term |
|---|---|
| D063729 | Sublingual Immunotherapy |
| ID | Term |
|---|---|
| D003888 | Desensitization, Immunologic |
| D007165 | Immunosuppression Therapy |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
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| Placebo | Drug | Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season |
|
|
| Montauban |
| France |
| Cab medical | Orange | France |
| Azienda Ospedaliera | Parma | Italy |
| Complejo Hospitalario de Caceres | Cáceres | Spain |
| HGU La Paz | Madrid | Spain |
| Any other reason not above-mentioned |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 300 IR | 300 IR grass pollen allergen extract tablet |
| OG001 | Placebo | Placebo tablet |
|
|
|
| Post-Hoc | Combined Score (CS) | The daily Combined Score (CS) is a patient specific score taking into account the patient's daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores. The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms). The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome. | The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Combined Score during the pollen period while on treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale (range: 0 to 3) | Pollen period (average of 32.1 days) |
|
|
|
|
| 1 |
| 188 |
| 110 |
| 188 |
| EG001 | Placebo | Placebo tablet | 1 | 193 | 63 | 193 |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 11.1. | Systematic Assessment |
|
| OEDEMA MOUTH | Gastrointestinal disorders | MedDRA Version 11.1. | Systematic Assessment |
|
| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.1. | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.1. | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.1. | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA Version 11.1. | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version 11.1. | Systematic Assessment |
|
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| D001691 |
| Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |