Trial Outcomes & Findings for Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis (NCT NCT00367640)

Last Updated: 2016-05-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

628 participants

Primary outcome timeframe

Pollen period (average of 32 days in the ITT set)

Results posted on

2016-05-23

Participant Flow

First Patient First Visit 30 NOV 2004, Last Patient Last Visit 05 SEP 2005

Participant milestones

Participant milestones
Measure	100 IR 100 IR grass pollen allergen extract tablet	300 IR 300 IR grass pollen allergen extract tablet	500 IR 500 IR grass pollen allergen extract tablet	Placebo Placebo tablet
Overall Study STARTED	157	155	160	156
Overall Study COMPLETED	139	133	141	146
Overall Study NOT COMPLETED	18	22	19	10

Reasons for withdrawal

Reasons for withdrawal
Measure	100 IR 100 IR grass pollen allergen extract tablet	300 IR 300 IR grass pollen allergen extract tablet	500 IR 500 IR grass pollen allergen extract tablet	Placebo Placebo tablet
Overall Study Adverse Event	3	6	8	0
Overall Study Withdrawal by Subject	8	11	8	6
Overall Study Any other reason not above-mentioned	7	5	3	4

Baseline Characteristics

Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	100 IR n=142 Participants 100 IR grass pollen allergen extract tablet	300 IR n=136 Participants 300 IR grass pollen allergen extract tablet	500 IR n=143 Participants 500 IR grass pollen allergen extract tablet	Placebo n=148 Participants Placebo tablet	Total n=569 Participants Total of all reporting groups
Age, Continuous	29.3 years STANDARD_DEVIATION 6.90 • n=5 Participants	28.7 years STANDARD_DEVIATION 7.34 • n=7 Participants	30.4 years STANDARD_DEVIATION 7.45 • n=5 Participants	29.1 years STANDARD_DEVIATION 7.60 • n=4 Participants	29.4 years STANDARD_DEVIATION 7.34 • n=21 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	62 Participants n=7 Participants	54 Participants n=5 Participants	60 Participants n=4 Participants	245 Participants n=21 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	74 Participants n=7 Participants	89 Participants n=5 Participants	88 Participants n=4 Participants	324 Participants n=21 Participants

PRIMARY outcome

Timeframe: Pollen period (average of 32 days in the ITT set)

Population: The intent-to-treat (ITT) population included all patients who received at least one dose of investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment.

Outcome measures

Outcome measures
Measure	100 IR n=142 Participants 100 IR grass pollen allergen extract tablet	300 IR n=136 Participants 300 IR grass pollen allergen extract tablet	500 IR n=143 Participants 500 IR grass pollen allergen extract tablet	Placebo n=148 Participants Placebo tablet
Average Rhinoconjunctivitis Total Symptom Score	4.72 Units on a scale (range: 0 to 18) Standard Deviation 3.141	3.58 Units on a scale (range: 0 to 18) Standard Deviation 2.976	3.74 Units on a scale (range: 0 to 18) Standard Deviation 3.142	4.93 Units on a scale (range: 0 to 18) Standard Deviation 3.229

Adverse Events

500 IR

Serious events: 3 serious events

Other events: 74 other events

Deaths: 0 deaths

300 IR

Serious events: 1 serious events

Other events: 70 other events

Deaths: 0 deaths

100 IR

Serious events: 0 serious events

Other events: 76 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	500 IR n=160 participants at risk 500 IR grass pollen allergen extract tablet	300 IR n=155 participants at risk 300 IR grass pollen allergen extract tablet	100 IR n=157 participants at risk 100 IR grass pollen allergen extract tablet	Placebo n=156 participants at risk Placebo tablet
Gastrointestinal disorders ABDOMINAL PAIN	0.62% 1/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.
Infections and infestations APPENDICITIS	0.62% 1/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.65% 1/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.62% 1/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.

Other adverse events

Other adverse events
Measure	500 IR n=160 participants at risk 500 IR grass pollen allergen extract tablet	300 IR n=155 participants at risk 300 IR grass pollen allergen extract tablet	100 IR n=157 participants at risk 100 IR grass pollen allergen extract tablet	Placebo n=156 participants at risk Placebo tablet
Gastrointestinal disorders ORAL PRURITUS	25.6% 41/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	25.8% 40/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	19.7% 31/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	5.1% 8/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.
Gastrointestinal disorders OEDEMA MOUTH	6.2% 10/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	4.5% 7/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	3.2% 5/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.
Gastrointestinal disorders TONGUE OEDEMA	5.6% 9/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	2.6% 4/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	3.2% 5/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.00% 0/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.
Nervous system disorders HEADACHE	8.8% 14/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	14.2% 22/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	14.6% 23/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	13.5% 21/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.
Respiratory, thoracic and mediastinal disorders THROAT IRRITATION	14.4% 23/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	9.0% 14/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	11.5% 18/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	3.2% 5/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.
Infections and infestations NASOPHARYNGITIS	7.5% 12/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	8.4% 13/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	10.2% 16/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	7.1% 11/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.
Skin and subcutaneous tissue disorders PRURITUS	1.9% 3/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	1.9% 3/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	6.4% 10/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.64% 1/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.
Ear and labyrinth disorders EAR PRURITUS	4.4% 7/160 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	3.2% 5/155 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	5.1% 8/157 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in Results Publication.	0.64% 1/156 • 4 months before the pollen period until the end of pollen period. Treatment-emergent adverse events (TEAEs) were defined as any adverse event that started on or after the first dose of the investigational product. Note: Serious Adverse Events and Other Adverse Events are described in 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