Efficacy and Safety of 100IR, 300IR, 500IR Sublingual Hou... | NCT01527188

NCT01527188

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
100 IR	Experimental	100 IR house dust mites allergen extract tablet	Drug: 100 IR house dust mites allergen extract tablet
300 IR	Experimental	300 IR house dust mites allergen extract tablet	Drug: 300 IR house dust mites allergen extract tablet
500 IR	Experimental	500 IR house dust mites allergen extract tablet	Drug: 500 IR house dust mites allergen extract tablet
Placebo	Placebo Comparator	Placebo tablet	Drug: Placebo tablet

Name	Type	Description	Arm Group Labels	Other Names
100 IR house dust mites allergen extract tablet	Drug	One sublingual tablet daily during 6 months	100 IR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 4 Hours (0-4h) of the Allergen Challenge	The primary efficacy endpoint was the change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the four hours of the allergen challenge in the Environmental Exposure Chamber (EEC). The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale. The RTSS was evaluated every 15 minutes in the first 2 hours and every 30 minutes in the last two hours, i.e. at 13 timepoints during each allergen challenge (from T0 to T240), and the scores were plotted against time (0 to 4 hours) to calculate the area under the curve, AUCRTSS_0-4h. A decrease in the AUCRTSS_0-4h value represents relief from the HDM allergic symptoms.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 2 Hours (2-4h) of the Allergen Challenge	Change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the last two hours (2-4h) of the allergen challenge in the Environmental Exposure Chamber (EEC). The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale.

Name	Affiliation	Role
Peter Couroux, MD, FRCPC	Cetero Research / PRACS Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cetero Research		Mississauga	Ontario	L4W 1N2	Canada

PubMed Identifier	Type	Citation	Retractions
39035788	Derived	Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul.

Results Section

Participant Flow Module

ID	Title	Description
FG000	100 IR	100 IR house dust mites allergen extract tablet
FG001	300 IR	300 IR house dust mites allergen extract tablet

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Units	Counts
Participants	BG00089 BG00186 BG00293 BG00387 BG004355

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

Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 4 Hours (0-4h) of the Allergen Challenge

The primary efficacy endpoint was the change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the four hours of the allergen challenge in the Environmental Exposure Chamber (EEC).

The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale. The RTSS was evaluated every 15 minutes in the first 2 hours and every 30 minutes in the last two hours, i.e. at 13 timepoints during each allergen challenge (from T0 to T240), and the scores were plotted against time (0 to 4 hours) to calculate the area under the curve, AUCRTSS_0-4h. A decrease in the AUCRTSS_0-4h value represents relief from the HDM allergic symptoms.

Full Analysis Set (FAS): all patients who received at least one dose of the investigational product.

(Number of patients at Visit 7 for whom data is available).

Posted

Least Squares Mean

Standard Error

RTSS * hour

6 months

ID	Title	Description
OG000	100 IR	100 IR house dust mites allergen extract tablet
OG001	300 IR	300 IR house dust mites allergen extract tablet
OG002	500 IR	500 IR house dust mites allergen extract tablet
OG003	Placebo	Placebo tablet

Units	Counts
Participants	OG00075 OG00168 OG00270 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-715.83± 67.261 OG001-769.21± 70.659 OG002-795.58± 69.877 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		ANCOVA		0.0427		Difference in LS Means	-198.18			2-Sided	95	-389.82	-6.55					Superiority or Other (legacy)
OG001 OG003		ANCOVA		0.0793

Secondary

Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 2 Hours (2-4h) of the Allergen Challenge

Change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the last two hours (2-4h) of the allergen challenge in the Environmental Exposure Chamber (EEC).

The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale.

Full Analysis Set (FAS): all patients who received at least one dose of the investigational product

Posted

Least Squares Mean

Standard Error

RTSS * hour

6 months

ID	Title	Description
OG000	100 IR	100 IR house dust mites allergen extract tablet
OG001	300 IR	300 IR house dust mites allergen extract tablet
OG002	500 IR	500 IR house dust mites allergen extract tablet
OG003	Placebo

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	100 IR	100 IR house dust mites allergen extract tablet	1	89	82	89
EG001	300 IR	300 IR house dust mites allergen extract tablet	1	86	73	86
EG002	500 IR	500 IR house dust mites allergen extract tablet	2	93	81	93
EG003	Placebo	Placebo tablet	0	87	71	87

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Meningitis	Infections and infestations	MedDRA Version 14.0.	Systematic Assessment	EG0000 events0 affected89 at risk EG0010 events0 affected86 at risk EG0021 events1 affected93 at risk EG0030 events0 affected87 at risk
Convulsion	Nervous system disorders	MedDRA Version 14.0.	Systematic Assessment	EG0000 events0 affected89 at risk EG0010 events0 affected86 at risk EG0021 events1 affected93 at risk EG003
Schizoaffective disorder	Psychiatric disorders	MedDRA Version 14.0.	Systematic Assessment	EG0000 events0 affected89 at risk EG0011 events1 affected86 at risk EG0020 events0 affected93 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 14.0.	Systematic Assessment	EG0001 events1 affected89 at risk EG0010 events0 affected86 at risk EG0020 events0 affected93 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Oral pruritus	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG00023 affected89 at risk EG00130 affected86 at risk EG00229 affected93 at risk EG0037 affected87 at risk
Oedema mouth	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG00016 affected89 at risk EG00119 affected86 at risk EG00220 affected93 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG00012 affected89 at risk EG0018 affected86 at risk EG0027 affected93 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0003 affected89 at risk EG0013 affected86 at risk EG0026 affected93 at risk EG003
Lip oedema	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0001 affected89 at risk EG0013 affected86 at risk EG0029 affected93 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0005 affected89 at risk EG0011 affected86 at risk EG0021 affected93 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG00028 affected89 at risk EG00132 affected86 at risk EG00237 affected93 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0007 affected89 at risk EG0017 affected86 at risk EG0028 affected93 at risk EG003
Ear pruritus	Ear and labyrinth disorders	MedDRA Version 14.0.	Systematic Assessment	EG00019 affected89 at risk EG00121 affected86 at risk EG00223 affected93 at risk EG003
Eye pruritus	Eye disorders	MedDRA Version 14.0.	Systematic Assessment	EG0007 affected89 at risk EG0014 affected86 at risk EG0026 affected93 at risk EG003
Headache	Nervous system disorders	MedDRA Version 14.0.	Systematic Assessment	EG00029 affected89 at risk EG00122 affected86 at risk EG00229 affected93 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0004 affected89 at risk EG0015 affected86 at risk EG0025 affected93 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0007 affected89 at risk EG0014 affected86 at risk EG0024 affected93 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0006 affected89 at risk EG0013 affected86 at risk EG0023 affected93 at risk EG003
Lip pruritus	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0003 affected89 at risk EG0014 affected86 at risk EG0025 affected93 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0003 affected89 at risk EG0015 affected86 at risk EG0021 affected93 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0001 affected89 at risk EG0013 affected86 at risk EG0025 affected93 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0005 affected89 at risk EG0013 affected86 at risk EG0020 affected93 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA Version 14.0.	Systematic Assessment	EG00028 affected89 at risk EG00128 affected86 at risk EG00226 affected93 at risk EG003
Pharyngitis	Infections and infestations	MedDRA Version 14.0.	Systematic Assessment	EG0003 affected89 at risk EG0012 affected86 at risk EG0029 affected93 at risk EG003
Chest discomfort	General disorders	MedDRA Version 14.0.	Systematic Assessment	EG0007 affected89 at risk EG0014 affected86 at risk EG0023 affected93 at risk EG003
Fatigue	General disorders	MedDRA Version 14.0.	Systematic Assessment	EG0004 affected89 at risk EG0015 affected86 at risk EG0021 affected93 at risk EG003
Pyrexia	General disorders	MedDRA Version 14.0.	Systematic Assessment	EG0005 affected89 at risk EG0011 affected86 at risk EG0021 affected93 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 14.0.	Systematic Assessment	EG0004 affected89 at risk EG0012 affected86 at risk EG0024 affected93 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA Version 14.0.	Systematic Assessment	EG0002 affected89 at risk EG0012 affected86 at risk EG0021 affected93 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 14.0.	Systematic Assessment	EG0003 affected89 at risk EG0013 affected86 at risk EG0022 affected93 at risk EG003
Forced expiratory volume decreased	Investigations	MedDRA Version 14.0.	Systematic Assessment	EG0007 affected89 at risk EG0017 affected86 at risk EG0024 affected93 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG00030 affected89 at risk EG00118 affected86 at risk EG00220 affected93 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG00016 affected89 at risk EG00111 affected86 at risk EG0027 affected93 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0006 affected89 at risk EG0013 affected86 at risk EG00213 affected93 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0002 affected89 at risk EG0016 affected86 at risk EG0025 affected93 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.0.	Systematic Assessment	EG0003 affected89 at risk EG0011 affected86 at risk EG0021 affected93 at risk EG003

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D010038	Otorhinolaryngologic Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

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