Trial Outcomes & Findings for Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis (NCT NCT00955825)

Last Updated: 2016-05-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

473 participants

Primary outcome timeframe

Pollen period (average of 42.8 days)

Results posted on

2016-05-19

Participant Flow

First Patient First Visit 22 OCT 2008, Last Patient Last Visit 13 AUG 2009

Participant milestones

Participant milestones
Measure	300 IR 300 IR grass pollen allergen extract tablet	Placebo Placebo tablet
Overall Study STARTED	233	240
Overall Study COMPLETED	207	223
Overall Study NOT COMPLETED	26	17

Reasons for withdrawal

Reasons for withdrawal
Measure	300 IR 300 IR grass pollen allergen extract tablet	Placebo Placebo tablet
Overall Study Adverse Event	15	2
Overall Study Withdrawal by Subject	4	6
Overall Study Any other reason not above-mentioned	7	9

Baseline Characteristics

Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300 IR n=210 Participants 300 IR grass pollen allergen extract tablet	Placebo n=228 Participants Placebo tablet	Total n=438 Participants Total of all reporting groups
Age, Continuous	36.8 years STANDARD_DEVIATION 11.27 • n=5 Participants	37.6 years STANDARD_DEVIATION 11.64 • n=7 Participants	37.2 years STANDARD_DEVIATION 11.46 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	125 Participants n=7 Participants	234 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	103 Participants n=7 Participants	204 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pollen period (average of 42.8 days)

Population: 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.

Outcome measures

Outcome measures
Measure	300 IR n=208 Participants 300 IR grass pollen allergen extract tablet	Placebo n=228 Participants Placebo tablet
Combined Score (CS)	0.32 Units on a scale (range: 0 to 3) Standard Error 0.033	0.45 Units on a scale (range: 0 to 3) Standard Error 0.032

Adverse Events

300 IR

Serious events: 2 serious events

Other events: 161 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 114 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	300 IR n=233 participants at risk 300 IR grass pollen allergen extract tablet	Placebo n=240 participants at risk Placebo tablet
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.42% 1/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.00% 0/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.42% 1/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Gastrointestinal disorders PALATAL DISORDER	0.43% 1/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.00% 0/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Infections and infestations GASTROENTERITIS	0.00% 0/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.42% 1/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE CARCINOMA	0.43% 1/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.00% 0/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.

Other adverse events

Other adverse events
Measure	300 IR n=233 participants at risk 300 IR grass pollen allergen extract tablet	Placebo n=240 participants at risk Placebo tablet
Infections and infestations NASOPHARYNGITIS	17.2% 40/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	17.5% 42/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	7.3% 17/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	8.8% 21/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Infections and infestations SINUSITIS	6.0% 14/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	6.2% 15/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Respiratory, thoracic and mediastinal disorders THROAT IRRITATION	23.2% 54/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	2.5% 6/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	7.3% 17/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	6.2% 15/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	7.7% 18/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	5.0% 12/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Respiratory, thoracic and mediastinal disorders COUGH	6.0% 14/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	3.3% 8/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Respiratory, thoracic and mediastinal disorders PHARYNGEAL OEDEMA	5.2% 12/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.42% 1/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Gastrointestinal disorders ORAL PRURITUS	24.5% 57/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	4.6% 11/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Gastrointestinal disorders OEDEMA MOUTH	9.4% 22/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.42% 1/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Gastrointestinal disorders PARAESTHESIA ORAL	9.4% 22/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.42% 1/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Nervous system disorders HEADACHE	6.4% 15/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	12.5% 30/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Eye disorders EYE PRURITUS	6.0% 14/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	2.9% 7/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.
Ear and labyrinth disorders EAR PRURITUS	13.3% 31/233 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.	0.42% 1/240 • 4 months before the pollen period until the end of the pollen period. A treatment-emergent adverse event (TEAE) is defined as any adverse event that started on or after the first administration of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in the Results Publication.

Additional Information

Laurence Paolozzi, Medical Director

Stallergenes

Phone: +33 (0) 1 55 59 26 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place