Safety and Efficacy of Sublingual Immunotherapy (SLIT) Ta... | NCT00367640

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
100 IR	Experimental	100 IR grass pollen allergen extract tablet	Drug: 100 IR grass pollen allergen extract tablet
300 IR	Experimental	300 IR grass pollen allergen extract tablet	Drug: 300 IR grass pollen allergen extract tablet
500 IR	Experimental	500 IR grass pollen allergen extract tablet	Drug: 500 IR grass pollen allergen extract tablet
Placebo	Placebo Comparator	Placebo tablet	Drug: Placebo tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
100 IR grass pollen allergen extract tablet	Drug	One sublingual tablet daily during 4 months before pollen season and during pollen season	100 IR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average Rhinoconjunctivitis Total Symptom Score	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.	Pollen period (average of 32 days in the ITT set)

Eligibility Module

Name	Affiliation	Role
Alain DIDIER, Professor	Hôpital Rangueil-Larrey, Toulouse, France	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17935764	Result	Didier A, Malling HJ, Worm M, Horak F, Jager S, Montagut A, Andre C, de Beaumont O, Melac M. Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5-grass pollen tablet for seasonal allergic rhinitis. J Allergy Clin Immunol. 2007 Dec;120(6):1338-45. doi: 10.1016/j.jaci.2007.07.046. Epub 2007 Nov 1.

Results Section

Participant Flow Module

ID	Title	Description
FG000	100 IR	100 IR grass pollen allergen extract tablet
FG001	300 IR	300 IR grass pollen allergen extract tablet

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	100 IR	100 IR grass pollen allergen extract tablet
BG001	300 IR	300 IR grass pollen allergen extract tablet
BG002	500 IR	500 IR grass pollen allergen extract tablet
BG003	Placebo	Placebo tablet
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG000142 BG001136 BG002143 BG003148 BG004569

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Average Rhinoconjunctivitis Total Symptom Score

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.

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.

Posted

Mean

Standard Deviation

Units on a scale (range: 0 to 18)

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

ID	Title	Description
OG000	100 IR	100 IR grass pollen allergen extract tablet
OG001	300 IR	300 IR grass pollen allergen extract tablet
OG002	500 IR	500 IR grass pollen allergen extract tablet
OG003	Placebo	Placebo tablet

Units	Counts
Participants	OG000142 OG001136 OG002143 OG003

Title

Denominators

Categories

Title	Measurements
	OG0004.72± 3.141 OG0013.58± 2.976 OG0023.74± 3.142 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG002 OG003	A step-down approach is performed to address the multiplicity issue.	ANCOVA		0.0006	ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.					2-Sided							No	Superiority or Other
OG001 OG003

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	500 IR	500 IR grass pollen allergen extract tablet	3	160	74	160
EG001	300 IR	300 IR grass pollen allergen extract tablet	1	155	70	155
EG002	100 IR	100 IR grass pollen allergen extract tablet	0	157	76	157
EG003	Placebo	Placebo tablet	0	156	36	156

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA Version 7.1.	Systematic Assessment	EG0001 affected160 at risk EG0010 affected155 at risk EG0020 affected157 at risk EG0030 affected156 at risk
APPENDICITIS	Infections and infestations	MedDRA Version 7.1.	Systematic Assessment	EG0001 affected160 at risk EG0010 affected155 at risk EG0020 affected157 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA Version 7.1.	Systematic Assessment	EG0000 affected160 at risk EG0011 affected155 at risk EG0020 affected157 at risk EG003
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA Version 7.1.	Systematic Assessment	EG0001 affected160 at risk EG0010 affected155 at risk EG0020 affected157 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ORAL PRURITUS	Gastrointestinal disorders	MedDRA Version 7.1.	Systematic Assessment	EG00041 affected160 at risk EG00140 affected155 at risk EG00231 affected157 at risk EG0038 affected156 at risk
OEDEMA MOUTH	Gastrointestinal disorders	MedDRA Version 7.1.	Systematic Assessment	EG00010 affected160 at risk EG0017 affected155 at risk EG0025 affected157 at risk EG003
TONGUE OEDEMA	Gastrointestinal disorders	MedDRA Version 7.1.	Systematic Assessment	EG0009 affected160 at risk EG0014 affected155 at risk EG0025 affected157 at risk EG003
HEADACHE	Nervous system disorders	MedDRA Version 7.1.	Systematic Assessment	EG00014 affected160 at risk EG00122 affected155 at risk EG00223 affected157 at risk EG003
THROAT IRRITATION	Respiratory, thoracic and mediastinal disorders	MedDRA Version 7.1.	Systematic Assessment	EG00023 affected160 at risk EG00114 affected155 at risk EG00218 affected157 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA Version 7.1.	Systematic Assessment	EG00012 affected160 at risk EG00113 affected155 at risk EG00216 affected157 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA Version 7.1.	Systematic Assessment	EG0003 affected160 at risk EG0013 affected155 at risk EG00210 affected157 at risk EG003
EAR PRURITUS	Ear and labyrinth disorders	MedDRA Version 7.1.	Systematic Assessment	EG0007 affected160 at risk EG0015 affected155 at risk EG0028 affected157 at risk EG003

ID	Term
D003888	Desensitization, Immunologic
D007165	Immunosuppression Therapy
D007167	Immunotherapy
D056747	Immunomodulation
D001691	Biological Therapy
D013812	Therapeutics
D007158	Immunologic Techniques
D008919	Investigative Techniques