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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011999-30 | EudraCT Number |
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Study population was insufficiently symptomatic to enable evaluation of the efficacy of the treatment. No safety concern.
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The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.
After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months.
An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300 IR | Active Comparator | 300 IR house dust mites allergen extract tablet |
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| Placebo | Placebo Comparator | Placebo tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300 IR house dust mites allergen extract tablet | Drug | One sublingual tablet daily for one year. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Adjusted Symptom Score (AASS) During the Treatment Period | The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome. It is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake | Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period |
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Inclusion Criteria:
Exclusion Criteria:
• Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Wahn, MD | Charite- Campus Virchow klinikum | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39035788 | Derived | Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul. |
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First Patient First Visit 27 OCT 2009, Last Patient Last Visit 30 SEP 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | 300 IR | 300 IR house dust mites allergen extract tablet |
| FG001 | Placebo | Placebo tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Year 1 |
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| Placebo tablet | Drug | One sublingual tablet daily for one year. |
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| COMPLETED |
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| NOT COMPLETED |
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| Year 2 |
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The Full Analysis Set included all randomized patients who received at least one dose of study treatment and had at least one evaluation of Adjusted Symptom Score (AdSS) during the treatment Year 1 period.
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| ID | Title | Description |
|---|---|---|
| BG000 | 300 IR | 300 IR house dust mites allergen extract tablet |
| BG001 | Placebo | Placebo tablet |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 (AASS) During the Treatment Period | The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome. It is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake | The Full Analysis Set included all randomized patients who received at least one dose of study treatment and had at least one evaluation of Adjusted Symptom Score (AdSS) during the treatment Year 1 period. | Posted | Least Squares Mean | Standard Error | units on a scale | Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period |
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Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months.
Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period.
A treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.
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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 house dust mites allergen extract tablet | 8 | 241 | 149 | 241 | ||
| EG001 | Placebo | Placebo tablet | 7 | 230 | 124 | 230 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | MedDRA version 12.1. | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA version 12.1. | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 12.1. | Systematic Assessment |
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| Ligament injury | Injury, poisoning and procedural complications | MedDRA version 12.1. | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.1. | Systematic Assessment |
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| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.1. | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA version 12.1. | Systematic Assessment |
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| Gastroenteritis salmonella | Infections and infestations | MedDRA version 12.1. | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA version 12.1. | Systematic Assessment |
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| Abortion induced | Surgical and medical procedures | MedDRA version 12.1. | Systematic Assessment |
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| Adjustment disorder | Psychiatric disorders | MedDRA version 12.1. | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA version 12.1. | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA version 12.1. | Systematic Assessment |
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| Varicocele | Reproductive system and breast disorders | MedDRA version 12.1. | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.1. | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.1. | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.1. | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA version 12.1. | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 12.1. | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA version 12.1. | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 12.1. | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 12.1. | Systematic Assessment |
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| Oral pruritus | Gastrointestinal disorders | MedDRA version 12.1. | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 12.1. | Systematic Assessment |
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| Tooth loss | Gastrointestinal disorders | MedDRA version 12.1. | Systematic Assessment |
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| Tongue oedema | Gastrointestinal disorders | MedDRA version 12.1. | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 12.1. | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 12.1. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michel Roux, Medical Director | Stallergenes | +33 (0) 1 55 59 29 70 | mroux@stallergenes.com |
| ID | Term |
|---|---|
| D000485 | Allergens |
| ID | Term |
|---|---|
| D000941 | Antigens |
| D001685 | Biological Factors |
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| Any other reason not above-mentioned |
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| Male |
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