A Phase 3 interventional study of 300 IR grass pollen allergen extract tablet and Placebo tablet in Allergy, sponsored by Stallergenes Greer. Completed at 1 site in Germany. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-05-26.
Sponsored by Stallergenes Greer · Phase 3, Interventional, and Treatment
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.
1,925 studies on the registry are indexed under Hypersensitivity; 261 are open to participants now.
This study's enrollment of 278 is above the median of 58 across 1,391 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Stallergenes Greer is the lead sponsor of 26 studies on the registry; none are open to participants now.
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300 IR grass pollen allergen extract tablet
Drug: 300 IR grass pollen allergen extract tablet
Placebo tablet
Drug: Placebo tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
Also known as: Sublingual immunotherapy tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
Also known as: Sublingual placebo tablet
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.
Time frame: Pollen period (average of 38.6 days)
First Patient First Visit 16 DEC 2006, Last Patient Last Visit 12 SEP 2007
| Milestone | 300 IR | Placebo |
|---|---|---|
| Started | 139 | 139 |
| Completed | 131 | 135 |
| Not completed | 8 | 4 |
| Withdrew: Adverse event | 7 | 2 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Any other reason not above-mentioned | 0 | 1 |
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.
| Units on a scale (range: 0 to 18) | 300 IR | Placebo |
|---|---|---|
| Average Rhinoconjunctivitis Total Symptom Score (ARTSS) | 3.25 ± 2.860 | 4.51 ± 2.931 |
Collected over 4 months before the pollen period until the end of pollen period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 300 IR | — | 2/139 (1.4%) | 107/139 (77%) |
| Placebo | — | 2/139 (1.4%) | 96/139 (69.1%) |
| Event | 300 IR | Placebo |
|---|---|---|
| ABDOMINAL PAINGastrointestinal disorders | 0/139 | 1/139 |
| GASTRODUODENITISGastrointestinal disorders | 0/139 | 1/139 |
| BURKITT'S LYMPHOMANeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/139 | 0/139 |
| ASTHMARespiratory, thoracic and mediastinal disorders | 1/139 | 0/139 |
| Event | 300 IR | Placebo |
|---|---|---|
| ORAL PRURITUSGastrointestinal disorders | 46/139 | 6/139 |
| COUGHRespiratory, thoracic and mediastinal disorders | 35/139 | 37/139 |
| HEADACHENervous system disorders | 11/139 | 24/139 |
| NASOPHARYNGITISInfections and infestations | 19/139 | 18/139 |
| OEDEMA MOUTHGastrointestinal disorders | 18/139 | 0/139 |
| PHARYNGITISInfections and infestations | 6/139 | 16/139 |
| WHEEZINGRespiratory, thoracic and mediastinal disorders | 8/139 | 13/139 |
| THROAT IRRITATIONRespiratory, thoracic and mediastinal disorders | 13/139 | 7/139 |
| NASAL CONGESTIONRespiratory, thoracic and mediastinal disorders | 12/139 | 9/139 |
| EYE PRURITUSEye disorders | 10/139 | 12/139 |
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.
| Age, Continuous(years) | 300 IR | Placebo | Total |
|---|---|---|---|
| Mean | 10.5 ± 3.34 | 11.2 ± 3.07 | 10.9 ± 3.22 |
| Sex: Female, Male(Participants) | 300 IR | Placebo | Total |
|---|---|---|---|
| Female | 45 | 50 | 95 |
| Male | 86 | 85 | 171 |
The record gives a start of Dec 2006, a primary completion of Sep 2007 and a completion of Sep 2007. It does not say whether these dates are actual or estimated.
Results were first posted in May 2016, 8 years 8 months after primary completion.
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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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