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A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300 IR (4M) | Experimental | 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season |
|
| 300 IR (2M) | Experimental | 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season |
|
| Placebo | Placebo Comparator | Placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300 IR (4M) | Drug | 300 IR grass pollen allergen extract tablet starting 4 months before the 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 Year 3 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 33.8 days) of Year 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain DIDIER, MD, Pr | Hôpital Rangueil-Larrey, Toulouse, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DIDIER | Toulouse | 31400 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21802126 | Result | Didier A, Worm M, Horak F, Sussman G, de Beaumont O, Le Gall M, Melac M, Malling HJ. Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis. J Allergy Clin Immunol. 2011 Sep;128(3):559-66. doi: 10.1016/j.jaci.2011.06.022. Epub 2011 Jul 29. | |
| 23600548 |
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First Patient First Visit 08 DEC 2006, Last Patient Last Visit 07 SEP 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | 300 IR (4M) | 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season |
| FG001 | 300 IR (2M) | 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season |
| FG002 | Placebo | Placebo tablet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 |
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| Year 2 |
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| Year 3 |
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| Year 4 |
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| Year 5 |
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Full Analysis Set Year 1 (FASY1). FASY1 included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score (ASS) during the pollen period while on treatment during the Year 1.
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| ID | Title | Description |
|---|---|---|
| BG000 | 300 IR (4M) | 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season |
| BG001 | 300 IR (2M) | 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season |
| 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 Year 3 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. | Full Analysis Set Year 3 (FASY3). FASY3 included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score (AdSS) during the pollen period while on treatment during the Year 3. | Posted | Least Squares Mean | Standard Error | Units on a scale (range: 0 to 18) | Pollen period (average of 33.8 days) of Year 3 |
Over 3 years during the treatment periods .
TEAEs were defined as any AE which started on or after the administration of the investigational product (IP) in the corresponding treatment period up to 30 days after the last administration of the IP (inclusive) for the corresponding period.
Note: Serious Adverse Events and Other Adverse Events are described in the Results Publications.
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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 (4M) | 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| APPENDICITIS | Infections and infestations | MedDRA Version 9.1. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| THROAT IRRITATION | 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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| 300 IR (2M) | Drug | 300 IR grass pollen allergen extract tablet starting 2 months before the pollen season |
|
|
| Placebo | Drug | Placebo tablet |
|
|
| Didier A, Malling HJ, Worm M, Horak F, Sussman G, Melac M, Soulie S, Zeldin RK. Post-treatment efficacy of discontinuous treatment with 300IR 5-grass pollen sublingual tablet in adults with grass pollen-induced allergic rhinoconjunctivitis. Clin Exp Allergy. 2013 May;43(5):568-77. doi: 10.1111/cea.12100. |
| 26097680 | Derived | Didier A, Malling HJ, Worm M, Horak F, Sussman GL. Prolonged efficacy of the 300IR 5-grass pollen tablet up to 2 years after treatment cessation, as measured by a recommended daily combined score. Clin Transl Allergy. 2015 May 22;5:12. doi: 10.1186/s13601-015-0057-8. eCollection 2015. |
| Any other reason not above-mentioned |
|
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
|
| BG002 | Placebo | Placebo tablet |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 300 IR (4M) | 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season |
| OG001 | 300 IR (2M) | 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season |
| OG002 | Placebo | Placebo tablet |
|
|
|
| 9 |
| 207 |
| 179 |
| 207 |
| EG001 | 300 IR (2M) | 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season | 7 | 207 | 167 | 207 |
| EG002 | Placebo | Placebo tablet | 6 | 219 | 170 | 219 |
| DIARRHOEA | Infections and infestations | MedDRA Version 9.1. | Systematic Assessment |
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| HEPATITIS B | Infections and infestations | MedDRA Version 9.1. | Systematic Assessment |
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| GENITAL INFECTION | Infections and infestations | MedDRA Version 9.1. | Systematic Assessment |
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| CERVICAL VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 9.1. | Systematic Assessment |
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| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 9.1. | Systematic Assessment |
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| CONTUSION | Injury, poisoning and procedural complications | MedDRA Version 9.1. | Systematic Assessment |
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| MENISCUS LESION | Injury, poisoning and procedural complications | MedDRA Version 9.1. | Systematic Assessment |
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| BENIGN NEOPLASM OF CERVIX UTERI | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 9.1. | Systematic Assessment |
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| TESTICULAR GERM CELL TUMOUR MIXED STAGE I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 9.1. | Systematic Assessment |
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| FAMILIAL MEDITERRANEAN FEVER | Congenital, familial and genetic disorders | MedDRA Version 9.1. | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA Version 9.1. | Systematic Assessment |
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| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA Version 9.1. | Systematic Assessment |
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| ECTOPIC PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA Version 9.1. | Systematic Assessment |
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| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA Version 9.1. | Systematic Assessment |
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| CONCUSSION | Injury, poisoning and procedural complications | MedDRA Version 9.1. | Systematic Assessment |
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| SPINAL COLUMN INJURY | Injury, poisoning and procedural complications | MedDRA Version 9.1. | Systematic Assessment |
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| ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA Version 9.1. | Systematic Assessment |
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| ABORTION INDUCED | Surgical and medical procedures | MedDRA Version 9.1. | Systematic Assessment |
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| EYE INJURY | Injury, poisoning and procedural complications | MedDRA Version 9.1. | Systematic Assessment |
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| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA Version 9.1. | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA Version 9.1. | Systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA Version 9.1. | Systematic Assessment |
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| RENAL COLIC | Renal and urinary disorders | MedDRA Version 9.1. | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| SNEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| ORAL PRURITUS | Gastrointestinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| OEDEMA MOUTH | Gastrointestinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| EYE PRURITUS | Eye disorders | MedDRA Version 9.1. | Systematic Assessment |
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| LACRIMATION INCREASED | Eye disorders | MedDRA Version 9.1. | Systematic Assessment |
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| CONJUNCTIVITIS ALLERGIC | Eye disorders | MedDRA Version 9.1. | Systematic Assessment |
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| CONJUNCTIVITIS | Eye disorders | MedDRA Version 9.1. | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA Version 9.1. | Systematic Assessment |
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| RHINITIS | Infections and infestations | MedDRA Version 9.1. | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA Version 9.1. | Systematic Assessment |
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| EAR PRURITUS | Ear and labyrinth disorders | MedDRA Version 9.1. | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| PHARYNGEAL OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| ORAL DISCOMFORT | Gastrointestinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| GLOSSODYNIA | Gastrointestinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| PARAESTHESIA ORAL | Gastrointestinal disorders | MedDRA Version 9.1. | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA Version 9.1. | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA Version 9.1. | Systematic Assessment |
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| SEASONAL ALLERGY | Immune system disorders | MedDRA Version 9.1. | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 9.1. | Systematic Assessment |
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| D001691 |
| Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |