Trial Outcomes & Findings for Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis (NCT NCT00803244)
NCT ID: NCT00803244
Last Updated: 2016-05-25
Results Overview
The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the 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.
COMPLETED
PHASE3
381 participants
Pollen period (average of 32.1 days)
2016-05-25
Participant Flow
First Patient First Visit 28 JAN 2009, Last Patient Last Visit 31 AUG 2009
Participant milestones
| Measure |
300 IR
300 IR grass pollen allergen extract tablet
|
Placebo
Placebo tablet
|
|---|---|---|
|
Overall Study
STARTED
|
188
|
193
|
|
Overall Study
COMPLETED
|
181
|
178
|
|
Overall Study
NOT COMPLETED
|
7
|
15
|
Reasons for withdrawal
| Measure |
300 IR
300 IR grass pollen allergen extract tablet
|
Placebo
Placebo tablet
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Any other reason not above-mentioned
|
4
|
10
|
Baseline Characteristics
Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis
Baseline characteristics by cohort
| Measure |
300 IR
n=178 Participants
300 IR grass pollen allergen extract tablet
|
Placebo
n=185 Participants
Placebo tablet
|
Total
n=363 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 9.87 • n=7 Participants
|
30.0 years
STANDARD_DEVIATION 10.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pollen period (average of 32.1 days)Population: The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score during the pollen period while on treatment.
The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the 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.
Outcome measures
| Measure |
300 IR
n=178 Participants
300 IR grass pollen allergen extract tablet
|
Placebo
n=184 Participants
Placebo tablet
|
|---|---|---|
|
Average Adjusted Symptom Score (AAdSS)
|
5.58 Units on a scale (range: 0 to 18)
Standard Error 0.330
|
6.07 Units on a scale (range: 0 to 18)
Standard Error 0.335
|
POST_HOC outcome
Timeframe: Pollen period (average of 32.1 days)Population: The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Combined Score during the pollen period while on treatment.
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.
Outcome measures
| Measure |
300 IR
n=178 Participants
300 IR grass pollen allergen extract tablet
|
Placebo
n=182 Participants
Placebo tablet
|
|---|---|---|
|
Combined Score (CS)
|
0.38 Units on a scale (range: 0 to 3)
Standard Error 0.038
|
0.48 Units on a scale (range: 0 to 3)
Standard Error 0.038
|
Adverse Events
300 IR
Placebo
Serious adverse events
| Measure |
300 IR
n=188 participants at risk
300 IR grass pollen allergen extract tablet
|
Placebo
n=193 participants at risk
Placebo tablet
|
|---|---|---|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/188 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
0.52%
1/193 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.53%
1/188 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
0.00%
0/193 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
Other adverse events
| Measure |
300 IR
n=188 participants at risk
300 IR grass pollen allergen extract tablet
|
Placebo
n=193 participants at risk
Placebo tablet
|
|---|---|---|
|
Gastrointestinal disorders
ORAL PRURITUS
|
31.9%
60/188 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
2.6%
5/193 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
|
Gastrointestinal disorders
OEDEMA MOUTH
|
6.9%
13/188 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
0.00%
0/193 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
16.5%
31/188 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
4.7%
9/193 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
4.8%
9/188 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
5.7%
11/193 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
4.3%
8/188 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
6.2%
12/193 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
|
Nervous system disorders
HEADACHE
|
17.0%
32/188 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
16.6%
32/193 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.9%
11/188 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
3.1%
6/193 • 2 months before the pollen period until the end of the pollen period.
A treatment-emergent adverse event (TEAE) is defined as any AE that started on or after the first dose of the investigational product was administered and is ongoing, or ended on or after the first dose of the investigational product.
|
Additional Information
Laurence Paolozzi, Medical Director
Stallergenes
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place