Evaluate the Effect of Omalizumab on Markers of Asthma Im... | NCT00870584

Status Module

Name	Class
Genentech, Inc.	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omalizumab	Experimental	The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.	Drug: Omalizumab
Placebo	Placebo Comparator	Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omalizumab	Drug	Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment	The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged >= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.	Baseline and 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks	The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question "What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study?" The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Jasper Summit Research, LLC		Jasper	Alabama	35501	United States
Allergy Asthma and Immunology Center of Alaska

Label	URL
Related Info	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Omalizumab	The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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 in Asthma Control Test (ACT) After 24 Weeks of Treatment

The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged >= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.

The Full Analysis Set consisted of patients to whom study drug had been assigned through randomization. Patients inappropriately randomized were excluded from this analysis set.

Participants with observations at both baseline and 24 weeks were included in the analysis.

Posted

Mean

Standard Deviation

Score on a scale

Baseline and 24 weeks

ID	Title	Description
OG000	Omalizumab	The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
OG001	Placebo	Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.

Units	Counts
Participants	OG000118 OG001123

Title

Denominators

Categories

Title	Measurements
	OG0005.2± 4.37 OG0014.7± 4.01

Secondary

Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks

The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question "What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study?" The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.

Full Analysis Set

Posted

Number

participants

24 weeks

ID	Title	Description
OG000	Omalizumab	The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
OG001	Placebo	Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Omalizumab	The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.			3	136	52	136
EG001	Placebo	Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.			5	135	51	135

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0010 affected135 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0010 affected135 at risk
Pericarditis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0010 affected135 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0011 affected135 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected136 at risk EG0011 affected135 at risk
Bronchitis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0010 affected135 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected136 at risk EG0011 affected135 at risk
Infected bites	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0010 affected135 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected136 at risk EG0011 affected135 at risk
Post procedural infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0010 affected135 at risk
Wound infection pseudomonas	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected136 at risk EG0011 affected135 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0010 affected135 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0010 affected135 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0010 affected135 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0010 affected135 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected136 at risk EG0012 affected135 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected136 at risk EG0010 affected135 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected136 at risk EG0019 affected135 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG00013 affected136 at risk EG0019 affected135 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00015 affected136 at risk EG00118 affected135 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 affected136 at risk EG0019 affected135 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00020 affected136 at risk EG00125 affected135 at risk

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D000888	Antibodies, Anti-Idiotypic
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Omalizumab	The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
BG001	Placebo	Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
BG002	Total	Total of all reporting groups