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The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.
The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.
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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 | 300 IR grass pollen allergen extract tablet once daily during four months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours | The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (]0-4] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS ]0-4] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Friedrich HORAK, Pr. MD | Allergy Center Vienna West, VIENNA, AUSTRIA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy Center Vienna West, Vienna Challenge Chamber - | Vienna | 1150 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19647862 | Result | Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Devillier P, Montagut A, Melac M, Galvain S, Jean-Alphonse S, Van Overtvelt L, Moingeon P, Le Gall M. Early onset of action of a 5-grass-pollen 300-IR sublingual immunotherapy tablet evaluated in an allergen challenge chamber. J Allergy Clin Immunol. 2009 Sep;124(3):471-7, 477.e1. doi: 10.1016/j.jaci.2009.06.006. Epub 2009 Aug 3. | |
| 24261946 |
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First Patient First Visit 17 SEP 2007, Last Patient Last Visit 10 MAR 2008
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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 randomised subjects who received at least one dose of the investigational product.
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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 of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours | The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (]0-4] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS ]0-4] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome. | The Intent-to-treat (ITT) population included all randomised subjects who received at least one dose of the investigational product. | Posted | Mean | Standard Error | Units on a scale (range: 0 to 18) | 4 months |
|
4 months.
A Treatment Emergent Adverse Event (TEAE) is defined as any adverse event that started on or after the first intake of the investigational product.
Note: Serious Adverse Events and Other Adverse Events are described in the 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pruritus | Ear and labyrinth disorders | MedDRA Version 10.1. | 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 |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D012220 | Rhinitis |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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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 | Placebo tablet once daily during four months |
|
|
| Derived |
| Baron-Bodo V, Horiot S, Lautrette A, Chabre H, Drucbert AS, Danze PM, Senechal H, Peltre G, Galvain S, Zeldin RK, Horak F, Moingeon P. Heterogeneity of antibody responses among clinical responders during grass pollen sublingual immunotherapy. Clin Exp Allergy. 2013 Dec;43(12):1362-73. doi: 10.1111/cea.12187. |
| 23181790 | Derived | Bonvalet M, Moussu H, Wambre E, Ricarte C, Horiot S, Rimaniol AC, Kwok WW, Horak F, de Beaumont O, Baron-Bodo V, Moingeon P. Allergen-specific CD4+ T cell responses in peripheral blood do not predict the early onset of clinical efficacy during grass pollen sublingual immunotherapy. Clin Exp Allergy. 2012 Dec;42(12):1745-55. doi: 10.1111/cea.12015. |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | 300 IR | 300 IR grass pollen allergen extract tablet |
| OG001 | Placebo | Placebo tablet |
|
|
|
| 0 |
| 45 |
| 24 |
| 45 |
| EG001 | Placebo | Placebo tablet | 0 | 44 | 9 | 44 |
| Oral pruritus | Gastrointestinal disorders | MedDRA Version 10.1. | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1. | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 10.1. | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 10.1. | Systematic Assessment |
|
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| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D001691 |
| Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |