Trial Outcomes & Findings for Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis (NCT NCT00409409)

Last Updated: 2016-05-26

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

PHASE3

Target enrollment

278 participants

Primary outcome timeframe

Pollen period (average of 38.6 days)

Results posted on

2016-05-26

Participant Flow

First Patient First Visit 16 DEC 2006, Last Patient Last Visit 12 SEP 2007

Participant milestones

Participant milestones
Measure	300 IR 300 IR grass pollen allergen extract tablet	Placebo Placebo tablet
Overall Study STARTED	139	139
Overall Study COMPLETED	131	135
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Reasons for withdrawal
Measure	300 IR 300 IR grass pollen allergen extract tablet	Placebo Placebo tablet
Overall Study Adverse Event	7	2
Overall Study Withdrawal by Subject	1	1
Overall Study Any other reason not above-mentioned	0	1

Baseline Characteristics

Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300 IR n=131 Participants 300 IR grass pollen allergen extract tablet	Placebo n=135 Participants Placebo tablet	Total n=266 Participants Total of all reporting groups
Age, Continuous	10.5 years STANDARD_DEVIATION 3.34 • n=99 Participants	11.2 years STANDARD_DEVIATION 3.07 • n=107 Participants	10.9 years STANDARD_DEVIATION 3.22 • n=206 Participants
Sex: Female, Male Female	45 Participants n=99 Participants	50 Participants n=107 Participants	95 Participants n=206 Participants
Sex: Female, Male Male	86 Participants n=99 Participants	85 Participants n=107 Participants	171 Participants n=206 Participants

PRIMARY outcome

Timeframe: Pollen period (average of 38.6 days)

Population: 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) in the pollen period while on treatment.

Outcome measures

Outcome measures
Measure	300 IR n=131 Participants 300 IR grass pollen allergen extract tablet	Placebo n=135 Participants Placebo tablet
Average Rhinoconjunctivitis Total Symptom Score (ARTSS)	3.25 Units on a scale (range: 0 to 18) Standard Deviation 2.860	4.51 Units on a scale (range: 0 to 18) Standard Deviation 2.931

Adverse Events

300 IR

Serious events: 2 serious events

Other events: 107 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 96 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	300 IR n=139 participants at risk 300 IR grass pollen allergen extract tablet	Placebo n=139 participants at risk Placebo tablet
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	0.72% 1/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 GASTRODUODENITIS	0.00% 0/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	0.72% 1/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BURKITT'S LYMPHOMA	0.72% 1/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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% 0/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 ASTHMA	0.72% 1/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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% 0/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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

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

Measure	300 IR n=139 participants at risk 300 IR grass pollen allergen extract tablet	Placebo n=139 participants at risk Placebo tablet
Respiratory, thoracic and mediastinal disorders COUGH	25.2% 35/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	26.6% 37/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 SNEEZING	7.9% 11/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	7.9% 11/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 NASAL CONGESTION	8.6% 12/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	6.5% 9/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 WHEEZING	5.8% 8/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	9.4% 13/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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	9.4% 13/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	5.0% 7/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 RHINORRHOEA	5.8% 8/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	7.2% 10/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 ASTHMA	7.2% 10/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	4.3% 6/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 NASAL DISCOMFORT	5.0% 7/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	6.5% 9/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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	13.7% 19/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	12.9% 18/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 PHARYNGITIS	4.3% 6/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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% 16/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 TONSILLITIS	6.5% 9/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	3.6% 5/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 ORAL PRURITUS	33.1% 46/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	4.3% 6/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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	12.9% 18/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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% 0/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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	7.9% 11/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	17.3% 24/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.
Eye disorders EYE PRURITUS	7.2% 10/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	8.6% 12/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 EPISTAXIS	2.2% 3/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	6.5% 9/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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 LIP SWELLING	5.0% 7/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	0.72% 1/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.
Eye disorders CONJUNCTIVITIS	2.9% 4/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	5.0% 7/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.
Eye disorders LACRIMATION INCREASED	1.4% 2/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.	5.8% 8/139 • 4 months before the pollen period until the end of pollen period. Treatment-emergent Adverse Events (TEAEs) are defined as events 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.