Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00454051

First received: March 28, 2007

Last updated: August 2, 2011

Last verified: August 2011

History of Changes

Results First Received: December 3, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: Omalizumab Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Participant Flow: Overall Study

	Omalizumab	Placebo
STARTED	20	11
COMPLETED	17	8
NOT COMPLETED	3	3
Adverse Event	1	2
Withdrawal by Subject	1	0
Protocol Violation	1	1

Baseline Characteristics

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Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
Total	Total of all reporting groups

Baseline Measures

	Omalizumab	Placebo	Total
Number of Participants [units: participants]	20	11	31
Age [units: years] Mean ± Standard Deviation	45.7 ± 13.30	50.6 ± 16.31	47.4 ± 14.37
Gender [units: participants]
Female	14	5	19
Male	6	6	12

Outcome Measures

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1. Primary:

Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo [ Time Frame: Baseline and Week 16 ]

Measure Type	Primary
Measure Title	Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo
Measure Description	Blood was drawn from participants at baseline and at Week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.
Time Frame	Baseline and Week 16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	16	11
Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo [units: percent change in FcεRI expression] Mean ± Standard Deviation
% Change in Basophils expressing FcεRI	-0.1 ± 8.39	3.9 ± 7.00
% Change in Dendritic cells expressing FcεRI	-5.9 ± 27.14	14.8 ± 22.80

No statistical analysis provided for Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo

2. Primary:

Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo [ Time Frame: Baseline and Week 16 ]

Measure Type	Primary
Measure Title	Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo
Measure Description	Blood was drawn from participants at baseline and at week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.
Time Frame	Baseline and Week 16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	16	11
Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo [units: percent change in fluorescence intensity] Mean ± Standard Deviation
% Change in Basophil fluorescence intensity	-77.5 ± 20.83	20.0 ± 76.70
% Change in Dendritic cell fluorescence intensity	-41.4 ± 36.90	36.7 ± 101.66

No statistical analysis provided for Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo

3. Secondary:

Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment [ Time Frame: Baseline, Weeks 4, 8, 12 and 16 ]

Measure Type	Secondary
Measure Title	Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment
Measure Description	Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.
Time Frame	Baseline, Weeks 4, 8, 12 and 16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	8	4
Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment [units: percent change in cells expressing FcεRI] Mean ± Standard Deviation
% change Basophils expressing FcεRI at Week 4	1.9 ± 7.89	-5.2 ± 8.46
% change Basophils expressing FcεRI at Week 8	2.5 ± 8.60	0.9 ± 1.49
% change Basophils expressing FcεRI at Week 12	3.7 ± 23.49	-6.4 ± 11.92
% change Basophils expressing FcεRI at Week 16	4.6 ± 9.40	-1.4 ± 3.29
% change Dendritic cells expressing FcεRI Week 4	-16.1 ± 33.54	-4.7 ± 17.73
% change Dendritic cells expressing FcεRI Week 8	-1.9 ± 14.66	6.2 ± 7.03
% change Dendritic cells expressing FcεRI Week 12	-10.3 ± 19.62	-2.8 ± 27.98
% change Dendritic cells expressing FcεRI Week 16	-9.8 ± 11.07	23.0 ± 24.70

No statistical analysis provided for Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment

4. Secondary:

Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment [ Time Frame: Baseline, Weeks 4, 8, 12, and 16 ]

Measure Type	Secondary
Measure Title	Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment
Measure Description	Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.
Time Frame	Baseline, Weeks 4, 8, 12, and 16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	8	4
Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment [units: % change in fluorescence intensity] Mean ± Standard Deviation
% change on basophils at Week 4	-85.1 ± 6.09	-45.8 ± 41.14
% change on basophils at Week 8	-81.0 ± 9.08	-11.5 ± 40.83
% change on basophils at Week 12	-86.8 ± 6.36	-24.2 ± 60.18
% change on basophils at Week 16	-88.6 ± 4.39	54.2 ± 11.71
% change on dendritic cells at Week 4	-38.6 ± 42.76	-36.6 ± 27.95
% change on dendritic cells at Week 8	-27.1 ± 40.13	-12.2 ± 42.56
% change on dendritic cells at Week 12	-31.2 ± 60.61	-14.1 ± 55.42
% change on dendritic cells at Week 16	-49.2 ± 30.21	47.1 ± 92.44

No statistical analysis provided for Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment

5. Secondary:

Change From Baseline in the Number of Days With Asthma Symptoms Per Week [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]

Measure Type	Secondary
Measure Title	Change From Baseline in the Number of Days With Asthma Symptoms Per Week
Measure Description	Participants maintained a diary to record the number of days with daytime asthma symptoms per week. This analysis compares the mean number of days per week with asthma symptoms during the 4-week screening period prior to randomization with the mean number of days per wek with asthma symptoms in the last 4 weeks of study treatment (Weeks 12 -16).
Time Frame	Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	20	11
Change From Baseline in the Number of Days With Asthma Symptoms Per Week [units: days per week] Mean ± Standard Deviation
Baseline	5.9 ± 1.71	4.5 ± 2.26
Change from Baseline	-2.3 ± 2.77	-0.9 ± 1.79

No statistical analysis provided for Change From Baseline in the Number of Days With Asthma Symptoms Per Week

6. Secondary:

Change From Baseline in the Number of Puffs of Rescue Medication Per Week [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]

Measure Type	Secondary
Measure Title	Change From Baseline in the Number of Puffs of Rescue Medication Per Week
Measure Description	Participants maintained a diary to record the daytime number of puffs of rescue Short-acting B2 agonist (SABA) used to treat asthma symptoms per week. This analysis compares the mean number of puffs of rescue medication per week during the 4 week screening period prior to randomization to the mean number of puffs per week during the last 4 weeks on study treatment (Weeks 12 - 16).
Time Frame	Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	20	11
Change From Baseline in the Number of Puffs of Rescue Medication Per Week [units: puffs per week] Mean ± Standard Deviation
Baseline	19.7 ± 24.68	10.5 ± 13.43
Change from Baseline	-2.0 ± 16.13	-2.7 ± 7.75

No statistical analysis provided for Change From Baseline in the Number of Puffs of Rescue Medication Per Week

7. Secondary:

Change From Baseline in the Number of Nights With Awakenings Per Week [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]

Measure Type	Secondary
Measure Title	Change From Baseline in the Number of Nights With Awakenings Per Week
Measure Description	Participants maintained a diary to record the number of nights with awakenings due to asthma symptoms per week. For this analysis, the mean number of nights with awakenings per week during the 4 week screening period prior to randomization was compared with the mean number of nights with awakenings per week during the last 4 weeks of study treatment (Weeks 12 - 16).
Time Frame	Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	20	11
Change From Baseline in the Number of Nights With Awakenings Per Week [units: nights with awakenings per week] Mean ± Standard Deviation
Baseline	2.5 ± 2.55	1.7 ± 2.15
Change from Baseline	-1.2 ± 2.08	-0.4 ± 1.31

No statistical analysis provided for Change From Baseline in the Number of Nights With Awakenings Per Week

8. Secondary:

Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]

Measure Type	Secondary
Measure Title	Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week
Measure Description	Impairment was defined as days with physical activity considered as limited (or "not normal") according to patient's assessment and was recorded in a patient daily diary. For this analysis, the mean number of days with impairment per week during the 4 week screening period prior to randomization was compared with the mean number of days with impairment per week during the last 4 weeks on study treatment (Weeks 12 - 16).
Time Frame	Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	20	11
Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week [units: days per week] Mean ± Standard Deviation
Baseline	4.9 ± 2.35	4.5 ± 2.41
Change from Baseline	-1.6 ± 2.43	-1.0 ± 2.53

No statistical analysis provided for Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week

9. Secondary:

Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]

Measure Type	Secondary
Measure Title	Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms
Measure Description	Participants maintained a diary to record the number of days with absence from school or work due to asthma symptoms. For this analysis, the number of days with absence from school or work in the four weeks prior to randomization (screening period) were compared with the number of absence days during the last 4 weeks on study treatment (Weeks 12 - 16).
Time Frame	Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	20	11
Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms [units: days] Mean ± Standard Deviation
Baseline	2.7 ± 7.38	2.5 ± 8.44
Change from Baseline	-0.9 ± 2.54	0.1 ± 0.30

No statistical analysis provided for Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms

10. Secondary:

Change From Baseline in the Number of Days With Hospitalizations [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]

Measure Type	Secondary
Measure Title	Change From Baseline in the Number of Days With Hospitalizations
Measure Description	Participants maintained a diary to record the number of days with hospitalizations during the study. For this analysis, the number of days with hospitalizations during the screening period (4 weeks prior to randomization) was compared with the number of days with hospitalizations during the last 4 weeks on study treatment (Weeks 12 - 16).
Time Frame	Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	20	11
Change From Baseline in the Number of Days With Hospitalizations [units: days] Mean ± Standard Deviation
Baseline	0.0 ± 0.0	0.0 ± 0.0
Change from Baseline	0.0 ± 0.0	0.0 ± 0.0

No statistical analysis provided for Change From Baseline in the Number of Days With Hospitalizations

11. Secondary:

Change From Baseline in the Number of Unscheduled Clinic Visits [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]

Measure Type	Secondary
Measure Title	Change From Baseline in the Number of Unscheduled Clinic Visits
Measure Description	Participants maintained a diary to record the number of unscheduled clinic visits during the study. For this analysis, the number of unscheduled visits during the 4 week screening period prior to randomization is compared with the number of unscheduled visits during the last 4 weeks on treatment (Weeks 12 - 16).
Time Frame	Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	20	11
Change From Baseline in the Number of Unscheduled Clinic Visits [units: unscheduled visits] Mean ± Standard Deviation
Baseline	0.2 ± 0.62	0.1 ± 0.30
Change from Baseline	-0.1 ± 0.55	0.1 ± 0.54

No statistical analysis provided for Change From Baseline in the Number of Unscheduled Clinic Visits

12. Secondary:

Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF) [ Time Frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16) ]

Measure Type	Secondary
Measure Title	Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF)
Measure Description	Peak Expiratory Flow (PEF) was measured every morning using a peak flow meter, and was recorded in the patient diary. For this analysis, the mean morning PEF during the 4-week screening period prior to randomizaton is compared with the mean morning PEF during the last 4 weeks of study treatment (Weeks 12 - 16).
Time Frame	Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	20	11
Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF) [units: liters per minute] Mean ± Standard Deviation
Baseline	303.5 ± 122.07	317.8 ± 77.37
Change from Baseline	9.9 ± 54.06	10.5 ± 28.8

No statistical analysis provided for Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF)

13. Secondary:

Physician's Overall Assessment of Treatment Effectiveness [ Time Frame: After 16 weeks of treatment ]

Measure Type	Secondary
Measure Title	Physician's Overall Assessment of Treatment Effectiveness
Measure Description	The Physician's overall assessment of treatment effectiveness was graded 1-5 as 1 = Excellent asthma control (complete control) 2 = Good asthma control (marked improvement) 3 = Moderate asthma control (discernible, but limited improvement) 4 = Poor asthma control (no appreciable change) 5 = Very poor asthma control (worsening)
Time Frame	After 16 weeks of treatment
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. Complete data for 26 of the total 30 participants was recorded.

Reporting Groups

	Description
Omalizumab	Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
Placebo	Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Measured Values

	Omalizumab	Placebo
Number of Participants Analyzed [units: participants]	17	9
Physician's Overall Assessment of Treatment Effectiveness [units: participants]
Excellent	3	1
Good	5	2
Moderate	6	4
Poor	3	1
Worsening	0	1

No statistical analysis provided for Physician's Overall Assessment of Treatment Effectiveness

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided by Novartis

Publications automatically indexed to this study:

Chanez P, Contin-Bordes C, Garcia G, Verkindre C, Didier A, De Blay F, de Lara MT, Blanco P, Moreau JF, Robinson P, Bourdeix I, Trunet P, Le Gros V, Humbert M, Molimard M. Omalizumab-induced decrease of Fc?RI expression in patients with severe allergic asthma. Respir Med. 2010 Nov;104(11):1608-17. Epub 2010 Aug 30.

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00454051 History of Changes
Other Study ID Numbers:	CIGE025AFR02
Study First Received:	March 28, 2007
Results First Received:	December 3, 2010
Last Updated:	August 2, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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