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A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.
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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 grass pollen allergen extract tablet | Drug | One sublingual tablet daily during 4 months before pollen season and during pollen season |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Rhinoconjunctivitis Total Symptom Score (ARTSS) | Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 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). The lower the score, the better the outcome. | Pollen period (average of 38.6 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Wahn, Professor | Charité - Campus Virchow Klinikum, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Campus Virchow Klinikum | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19046761 | Result | Wahn U, Tabar A, Kuna P, Halken S, Montagut A, de Beaumont O, Le Gall M; SLIT Study Group. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2009 Jan;123(1):160-166.e3. doi: 10.1016/j.jaci.2008.10.009. Epub 2008 Nov 29. |
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First Patient First Visit 16 DEC 2006, Last Patient Last Visit 12 SEP 2007
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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 |
|
|
The Intent-to-treat (ITT) population included all patients who received at least one dose of the investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) 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 Rhinoconjunctivitis Total Symptom Score (ARTSS) | Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 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). The lower the score, the better the outcome. | The Intent-to-treat (ITT) population included all patients who received at least one dose of the investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment. | Posted | Mean | Standard Deviation | Units on a scale (range: 0 to 18) | Pollen period (average of 38.6 days) |
|
4 months before the pollen period until the end of pollen period.
Treatment-emergent Adverse Events (TEAEs) are defined as events that started on or after the first dose of the investigational product.
Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.
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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 |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA Version 9.1. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1 | 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 |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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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 tablet | Drug | One sublingual tablet daily during 4 months before pollen season and during pollen season |
|
|
| Any other reason not above-mentioned |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 300 IR |
300 IR grass pollen allergen extract tablet |
| OG001 | Placebo | Placebo tablet |
|
|
|
| 2 |
| 139 |
| 107 |
| 139 |
| EG001 | Placebo | Placebo tablet | 2 | 139 | 96 | 139 |
| GASTRODUODENITIS | Gastrointestinal disorders | MedDRA Version 9.1. | Systematic Assessment |
|
| BURKITT'S LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 9.1. | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1. | Systematic Assessment |
|
| SNEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version 9.1 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA Version 9.1 | Systematic Assessment |
|
| TONSILLITIS | Infections and infestations | MedDRA Version 9.1 | Systematic Assessment |
|
| ORAL PRURITUS | Gastrointestinal disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| OEDEMA MOUTH | Gastrointestinal disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| EYE PRURITUS | Eye disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| LIP SWELLING | Gastrointestinal disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| CONJUNCTIVITIS | Eye disorders | MedDRA Version 9.1 | Systematic Assessment |
|
| LACRIMATION INCREASED | Eye disorders | MedDRA Version 9.1 | Systematic Assessment |
|
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| D001691 |
| Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |