A Phase 3 interventional study of 300 IR and Placebo in Allergic Rhinitis Due to Grass Pollens, sponsored by Stallergenes Greer. Completed at 19 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-19.
Sponsored by Stallergenes Greer · Phase 3, Interventional, and Treatment
The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.
Allergy is one of the most common chronic disease in the world currently affecting between 10% and 25% of the general population.
Allergies to pollens characteristically result in seasonal rhinitis symptoms and allergic rhinoconjunctivitis is characterized by sneezing, congestion, rhinorrhea, nasal or palatal itching and itchy, watery, red and swollen eyes.
Even if several drugs effectively manage allergic rhinoconjunctivitis symptoms, immunotherapy is considered more appropriate for patients in whom these symptoms are not optimally controlled with relief medications.
In the study, each of the six rhinoconjunctivitis symptoms (sneezing, runny nose, itchy nose, nasal congestion, itchy eyes, watery eyes) will be evaluated daily and relief medication intake (oral antihistamines, eye drop antihistamine, nasal corticosteroid, oral corticosteroid) reported daily during the grass pollen season.
Efficacy and good safety profile of 300IR SLIT tablet administered once per day for approximately six months (starting 4 months before and over the season) will be demonstrated during the grass pollen season compared to placebo.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 473 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Stallergenes Greer is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
300 IR grass pollen allergen extract tablet
Drug: 300 IR
Pacebo tablet
Drug: Placebo
300 IR grass pollen allergen extract tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
Also known as: Sublingual immunotherapy tablet
Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
Also known as: Sublingual placebo tablet
Combined Score (CS)
The daily Combined Score (CS) is a patient specific score taking into account the patient's daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores. The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms). The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome.
Time frame: Pollen period (average of 42.8 days)
First Patient First Visit 22 OCT 2008, Last Patient Last Visit 13 AUG 2009
| Milestone | 300 IR | Placebo |
|---|---|---|
| Started | 233 | 240 |
| Completed | 207 | 223 |
| Not completed | 26 | 17 |
| Withdrew: Adverse event | 15 | 2 |
| Withdrew: Withdrawal by subject | 4 | 6 |
| Withdrew: Any other reason not above-mentioned | 7 | 9 |
The daily Combined Score (CS) is a patient specific score taking into account the patient's daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores. The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms). The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome.
| Units on a scale (range: 0 to 3) | 300 IR | Placebo |
|---|---|---|
| Combined Score (CS) | 0.32 ± 0.033 | 0.45 ± 0.032 |
Collected over 4 months before the pollen period until the end of the pollen period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 300 IR | — | 2/233 (0.9%) | 161/233 (69.1%) |
| Placebo | — | 2/240 (0.8%) | 114/240 (47.5%) |
| Event | 300 IR | Placebo |
|---|---|---|
| PALATAL DISORDERGastrointestinal disorders | 1/233 | 0/240 |
| NEUROENDOCRINE CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/233 | 0/240 |
| HAEMATOCHEZIAGastrointestinal disorders | 0/233 | 1/240 |
| INTESTINAL OBSTRUCTIONGastrointestinal disorders | 0/233 | 1/240 |
| GASTROENTERITISInfections and infestations | 0/233 | 1/240 |
| Event | 300 IR | Placebo |
|---|---|---|
| ORAL PRURITUSGastrointestinal disorders | 57/233 | 11/240 |
| THROAT IRRITATIONRespiratory, thoracic and mediastinal disorders | 54/233 | 6/240 |
| NASOPHARYNGITISInfections and infestations | 40/233 | 42/240 |
| EAR PRURITUSEar and labyrinth disorders | 31/233 | 1/240 |
| HEADACHENervous system disorders | 15/233 | 30/240 |
| OEDEMA MOUTHGastrointestinal disorders | 22/233 | 1/240 |
| PARAESTHESIA ORALGastrointestinal disorders | 22/233 | 1/240 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 17/233 | 21/240 |
| OROPHARYNGEAL PAINRespiratory, thoracic and mediastinal disorders | 18/233 | 12/240 |
| NASAL CONGESTIONRespiratory, thoracic and mediastinal disorders | 17/233 | 15/240 |
The Full Analysis Set (FAS) includes all patients who received at least one dose of the investigational product and had at least one Combined Score while on treatment during the pollen period. The FAS was regarded as primary for the efficacy evaluations.
| Age, Continuous(years) | 300 IR | Placebo | Total |
|---|---|---|---|
| Mean | 36.8 ± 11.27 | 37.6 ± 11.64 | 37.2 ± 11.46 |
| Sex: Female, Male(Participants) | 300 IR | Placebo | Total |
|---|---|---|---|
| Female | 109 | 125 | 234 |
| Male | 101 | 103 | 204 |
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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Stallergenes Greer