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Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma

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ClinicalTrials.gov Identifier: NCT00264849
Recruitment Status : Completed
First Posted : December 13, 2005
Results First Posted : July 25, 2011
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
Genentech, Inc.
Tanox
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Omalizumab
Other: Optimized asthma therapy
Enrollment 406
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level. During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Period Title: Overall Study
Started 275 131
Completed 253 106
Not Completed 22 25
Reason Not Completed
Adverse Event             7             2
Withdrawal by Subject             7             11
Protocol Violation             5             3
Lack of Efficacy             1             6
Lost to Follow-up             0             2
Death             0             1
Administrative Problems             2             0
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT) Total
Hide Arm/Group Description During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level. During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks. Total of all reporting groups
Overall Number of Baseline Participants 272 128 400
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 128 participants 400 participants
<=18 years
5
   1.8%
0
   0.0%
5
   1.3%
Between 18 and 65 years
250
  91.9%
118
  92.2%
368
  92.0%
>=65 years
17
   6.3%
10
   7.8%
27
   6.8%
[1]
Measure Description: All demographic data is described for the Modified ITT population. The modified ITT population includes all randomized patients with at least one post-baseline efficacy assessment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 272 participants 128 participants 400 participants
45.6  (13.04) 45.7  (12.57) 45.7  (12.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 128 participants 400 participants
Female
183
  67.3%
76
  59.4%
259
  64.8%
Male
89
  32.7%
52
  40.6%
141
  35.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 128 participants 400 participants
American Indian or Alaska Native
2
   0.7%
0
   0.0%
2
   0.5%
Asian
1
   0.4%
1
   0.8%
2
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
266
  97.8%
125
  97.7%
391
  97.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   1.1%
2
   1.6%
5
   1.3%
1.Primary Outcome
Title Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)
Hide Description Persistency of response, based on GETE, was dichotomized into responders (excellent or good) and non-responders (moderate, poor or worsening). Persistent responders were patients who were responders at 16 weeks and still at 32 weeks. Persistent non-responders were patients who were non-responders at 16 weeks and still at 32 weeks. Patients were assessed for persistency of response if they were responders at Week 16 and had a second GETE obtained ≥ 4 weeks after the Week 16 assessment or discontinued prematurely for unsatisfactory therapeutic effect ≥ 4 weeks after the Week 16 assessment.
Time Frame Weeks 16 and 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) was defined for efficacy analyses which included all randomized patients who had at least one post-baseline efficacy assessment.
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 272 128
Measure Type: Number
Unit of Measure: participants
Number of responders at Wk 16 190 29
Participants available to assess persistency 187 28
Number of Persistent Responders at Weeks 16 and 32 171 18
Number of non-responders at Week 16 71 64
Participants to assess persistency of non respond 71 63
Number of Persistent Non-responders at Wks 16and32 44 57
2.Secondary Outcome
Title Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Hide Description Number of participants with persistent response, based on the investigator’s GETE, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32. Persistency was defined as the proportion of responders at 16 weeks who were still responders at 32 weeks. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
Time Frame Weeks 16 and 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT)
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 272 128
Measure Type: Number
Unit of Measure: participants
Week 16: Excellent 35 1
Week 16: Good 155 28
Week 16: Moderate 57 24
Week 16: Poor 13 34
Week 16: Worsening 1 6
Week 16: Missing 11 35
Week 16: Responders (excellent and good) 190 29
Week 16: Non-responders (moderate, poor, worse) 71 64
Week 32: Excellent 73 1
Week 32: Good 126 24
Week 32: Moderate 45 31
Week 32: Poor 13 39
Week 32: Worsening 2 9
Week 32: Missing 13 24
Week 32: Responders (excellent and good) 199 25
Week 32: Non-responders (moderate, poor, worse) 60 79
Responder at both weeks (Weeks 16 and 32) 171 18
3.Secondary Outcome
Title Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Investigator's GETE
Hide Description Responders were defined as excellent or good based on the investigator's Global Evaluation of Treatment Effectiveness (GETE) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32.
Time Frame Weeks 16 and 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT)
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 272 128
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62.9
(57.1 to 68.6)
14.1
(8.0 to 20.1)
4.Secondary Outcome
Title Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Hide Description Number of participants with persistent response, based on the patient's GETE, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32. Persistency was defined as the proportion of responders at 16 weeks who were still responders at 32 weeks. This is based on the patient's evaluation.
Time Frame Weeks 16 and 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT)
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 272 128
Measure Type: Number
Unit of Measure: participants
Week 16: Excellent 54 4
Week 16: Good 139 29
Week 16: Moderate 53 23
Week 16: Poor 15 33
Week 16: Worsening 1 5
Week 16: Missing 10 34
Week 16: Responders (excellent and good) 193 33
Week 16:Non-responders (moderate, poor, worsening) 69 61
Week 32: Excellent 80 2
Week 32: Good 127 27
Week 32: Moderate 38 28
Week 32: Poor 12 38
Week 32: Worsening 2 8
Week 32: Missing 13 25
Week 32: Responders (excellent and good) 207 29
Week 32: Non-responders (moderate, poor, worse) 52 74
5.Secondary Outcome
Title Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Patient's GETE
Hide Description Responders were defined as excellent or good based on the patient's Global Evaluation of Treatment Effectiveness (GETE) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32.
Time Frame Weeks 16 and 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population and patients who were assessed for persistency of response or non-response at Week 16 and had a GETE obtained >= 4 weeks after the Week 16 assessment or discontinued prematurely or unsatisfactory therapeutic effect >= 4 weeks after the Week 16 assessment. N=187/28 for OAT+Omalizumab/OAT for responders and N=71/63 for non-responders.
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 272 128
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.2
(57.5 to 69.0)
15.6
(9.3 to 21.9)
6.Secondary Outcome
Title Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)
Hide Description Predicted FEV1 was calculated using the Crapo formula for data at Visit 6 (time of randomization), (MALES: Predicted FEV1 (L) = 0.0414*height - 0.0244*age -2.190 and Females: Predicted FEV1 (L) = 0.0342*height - 0.0255*age - 1.578, where height is in cm).
Time Frame Weeks 16 and 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT), for Week 16 N=258/106 for OAT+Omalizumab/OAT and for Week 32 N=266/121 for OAT+Omalizumab/OAT, respectively.
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 272 128
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent predicted FEV1
Week 16
68.4
(66.2 to 70.5)
64.8
(61.8 to 67.8)
Week 32
68.1
(65.8 to 70.5)
63.7
(60.6 to 66.8)
7.Secondary Outcome
Title Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32
Hide Description Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ has six questions to be answered by the patient, each with a 7 point scale (0–good control, 6–poor control), and one question where the actual pre-bronchodilator FEV1 value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms.
Time Frame Baseline, Week 16, Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT with N counts as noted in the category description. To be included in this table patients must have a ACQ measurement for the specified timepoint.
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 272 128
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 16 (N=249,104)
-0.78
(-0.92 to -0.63)
-0.11
(-0.31 to 0.10)
Week 32 (N=238,104)
-0.91
(-1.07 to -0.76)
-0.04
(-0.26 to 0.17)
Last post-baseline (N=255,119)
-0.84
(-1.00 to -0.69)
0.07
(-0.14 to 0.27)
8.Secondary Outcome
Title Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period
Hide Description A clinically significant exacerbation episode was defined as a worsening of asthma requiring treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the rescue systemic corticosteroids marked the start of a clinically significant asthma exacerbation episode and cessation of the rescue systemic corticosteroids regimen marked the end of a clinically significant exacerbation episode. If an exacerbation episode was duplicated, overlapped by at least one day with another episode, or nested within another exacerbation episode, only one exacerbation was counted.
Time Frame 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 272 128
Measure Type: Number
Unit of Measure: participants
0 asthma exacerbations 183 64
1 asthma exacerbation 58 35
2 asthma exacerbations 18 17
3 asthma exacerbations 9 6
>= 4 asthma exacerbations 4 6
9.Secondary Outcome
Title Medical Resource Utilization: Number of Participants With Combined Hospital Admissions, Emergency Room Visits, and Other Outpatient Clinical Visits Due to an Asthma Exacerbation During the 32 Week Treatment Period
Hide Description A combined total of unscheduled visits due to asthma exacerbations was calculated for each patient as the total number of hospital admissions, ER visits and unscheduled outpatient clinical visits due to asthma exacerbation. Where more than one type of visit was required on a single day for an asthma exacerbation only the most serious type was included. Where there was more than one visit for a single asthma exacerbation but the visits occurred on different dates, then all were counted.
Time Frame 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT)
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 272 128
Measure Type: Number
Unit of Measure: participants
0 combined visits/hospitalizations 226 86
1 combined visit/hospitalization 26 12
2 combined visits/hospitalizations 10 17
3 combined visits/hospitalizations 4 8
>= 4 combined visits/hospitalizations 6 5
Total number of combined visits/hospitalizations 92 100
10.Secondary Outcome
Title Percent Change in Dose of Maintenance Systemic Steroids at Weeks 16 and 32
Hide Description For the subgroup of patients requiring maintenance oral (systemic) corticosteroids throughout the screening period the dose of oral steroid (expressed as prednisolone equivalent dose) at baseline, Week 16 and Week 32 was presented by treatment group, as well as the absolute and percent change from baseline to Weeks 16 and 32. It should be noted that the dose of oral steroid at Weeks 16 and 32 was the dose the patient was maintained on and not the dose to treat an exacerbation if one occurred at that time.
Time Frame Weeks 16 and 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT patients with systemic steriods at baseline (defined as those patient who used systemic steroids throughout the entire run-in period from Visit 1 to Visit 6). N counts as noted in the category description.
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 59 23
Mean (Standard Deviation)
Unit of Measure: percent change
Week 16 (N=56,19) -20.1  (63.08) 36.8  (212.03)
Week 32 (N=59,23) -45.0  (50.22) 18.3  (85.13)
11.Secondary Outcome
Title Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32
Hide Description The type of change for the dose of maintenance systemic steroids could be presented as removal (no more maintenance systemic steroids used), decreased, or maintained.
Time Frame Weeks 16 and 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT patients with systemic steroids at baseline (defined as those patient who used systemic steroids throughout the entire run-in period from Visit 1 to Visit 6).
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 59 23
Measure Type: Number
Unit of Measure: participants
Week 16 - Removed systemic steroids (N=56,19) 10 2
Week 16 - Decreased systemic steroids (N=56,19) 14 2
Week 16 - Maintained systemic steroids (N=56,19) 32 15
Week 32 - Removed systemic steroids 19 3
Week 32 - Decreased systemic steroids 18 4
Week 32 - Maintained systemic steroids 22 16
12.Secondary Outcome
Title Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Hide Description There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1–totally limited/problems all the time, 7–not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.
Time Frame Baseline, Week 15, Week 31
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT at Week 15 for OAT + Omalizumab is 214 patients and for OAT is 92 patients; at Week 31 for OAT + Omalizumab is 224 patients and for OAT is 97 patients except as noted in the category description. To be included in this table patients must have a AQLQ measurement for the specified timepoint.
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 272 128
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Overall Score: Week 15
0.90
(0.73 to 1.07)
0.03
(-0.20 to 0.27)
Overall Score: Week 31
1.06
(0.88 to 1.24)
-0.07
(-0.31 to 0.17)
Symptom Score: Week 15
0.89
(0.70 to 1.09)
-0.05
(-0.31 to 0.22)
Symptom Score: Week 31
1.07
(0.88 to 1.27)
-0.07
(-0.34 to 0.19)
Activities Score: Week 15
0.87
(0.70 to 1.04)
0.03
(-0.20 to 0.26)
Activities Score: Week 31
1.08
(0.91 to 1.26)
-0.07
(-0.31 to 0.17)
Emotions Score: Week 15
0.98
(0.78 to 1.18)
0.20
(-0.07 to 0.48)
Emotions Score: Week 31
1.08
(0.88 to 1.28)
-0.07
(-0.34 to 0.19)
Enironmental Exposure Score: Week 15 (N=213,91)
0.84
(0.66 to 1.02)
0.10
(-0.15 to 0.34)
Enironmental Exposure Score: Week 31(N=223,96)
0.91
(0.71 to 1.11)
-0.01
(-0.29 to 0.26)
13.Secondary Outcome
Title Change From Baseline in EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) Index Score and Health State Assessment on Scale From 0 to 100 at Weeks 15 and 31
Hide Description The utility-based EQ-5D questionnaire is in two parts and provides a generic measure of health for clinical and economic appraisal. The first "health state classification" part has 5 questions each with 3 categories (no problem, moderate problem, severe problems). The second "visual analogue scale" was measured from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame Baseline, Week 15, Week 31
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat with N count as noted in category description.
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 272 128
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
EQ-5D Utility Index Score: Week 15 (N=212,90)
0.071
(0.038 to 0.105)
0.002
(-0.044 to 0.049)
EQ-5D Utility Index Score: Week 31 (N=194,81)
0.091
(0.051 to 0.132)
0.064
(0.008 to 0.121)
Health State Assessment: Week 15 (N=211,89)
8.2
(4.7 to 11.8)
-0.4
(-5.4 to 4.6)
Health State Assessment: Week 31 (N=194,80)
9.3
(5.2 to 13.4)
-2.8
(-8.5 to 3.0)
14.Secondary Outcome
Title Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems
Hide Description The Work Productivity and Activity Impairment-Allergic Asthma (WPAI-AA) questionnaire measures time missed from work, impairment of work and regular activities within the last 7 days. Questionnaires were administered via phone 1 week prior to the study visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Overall work impairment due to asthma problems is derived from the proportion of hours missed from work due to asthma and the degree to which asthma problems affected productivity while working.
Time Frame Baseline and Week 31
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Hide Analysis Population Description
Modified Intent-to-Treat. Only patients only who worked and with values at both baseline and Week 31 visit were included. Sensitivity analysis excluded questionnaires which were answered after the clinic visit.
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description:
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
Overall Number of Participants Analyzed 78 32
Mean (Standard Deviation)
Unit of Measure: percent impairment
Baseline 41.3  (26.19) 39.4  (24.91)
Week 31 20.5  (24.28) 40.3  (27.97)
Change from baseline at Week 31 -20.8  (26.38) 0.8  (30.34)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OAT + Omalizumab Optimized Asthma Treatment (OAT)
Hide Arm/Group Description During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level. During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
All-Cause Mortality
OAT + Omalizumab Optimized Asthma Treatment (OAT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OAT + Omalizumab Optimized Asthma Treatment (OAT)
Affected / at Risk (%) Affected / at Risk (%)
Total   29/274 (10.58%)   17/128 (13.28%) 
Cardiac disorders     
Cardiac arrest  1  1/274 (0.36%)  0/128 (0.00%) 
Endocrine disorders     
Goitre  1  1/274 (0.36%)  0/128 (0.00%) 
Hyperparathyroidism  1  1/274 (0.36%)  0/128 (0.00%) 
Gastrointestinal disorders     
Melaena  1  0/274 (0.00%)  1/128 (0.78%) 
General disorders     
Chest pain  1  1/274 (0.36%)  0/128 (0.00%) 
Oedema peripheral  1  1/274 (0.36%)  0/128 (0.00%) 
Polyp  1  0/274 (0.00%)  1/128 (0.78%) 
Immune system disorders     
Drug hypersensitivity  1  0/274 (0.00%)  1/128 (0.78%) 
Infections and infestations     
Bronchitis  1  0/274 (0.00%)  2/128 (1.56%) 
Gastroenteritis  1  1/274 (0.36%)  0/128 (0.00%) 
Lower respiratory tract infection  1  1/274 (0.36%)  1/128 (0.78%) 
Orchitis  1  1/274 (0.36%)  0/128 (0.00%) 
Pneumonia  1  1/274 (0.36%)  0/128 (0.00%) 
Respiratory tract infection viral  1  1/274 (0.36%)  0/128 (0.00%) 
Urosepsis  1  1/274 (0.36%)  0/128 (0.00%) 
Injury, poisoning and procedural complications     
Chest injury  1  2/274 (0.73%)  0/128 (0.00%) 
Contusion  1  2/274 (0.73%)  0/128 (0.00%) 
Facial bones fracture  1  1/274 (0.36%)  0/128 (0.00%) 
Fractured coccyx  1  1/274 (0.36%)  0/128 (0.00%) 
Road traffic accident  1  3/274 (1.09%)  0/128 (0.00%) 
Upper limb fracture  1  1/274 (0.36%)  0/128 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/274 (0.36%)  0/128 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/274 (0.36%)  0/128 (0.00%) 
Back pain  1  0/274 (0.00%)  1/128 (0.78%) 
Foot deformity  1  1/274 (0.36%)  0/128 (0.00%) 
Intervertebral disc protrusion  1  0/274 (0.00%)  1/128 (0.78%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast neoplasm  1  1/274 (0.36%)  0/128 (0.00%) 
Fibroadenoma of breast  1  1/274 (0.36%)  0/128 (0.00%) 
Nervous system disorders     
Headache  1  1/274 (0.36%)  0/128 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Intra-uterine death  1  1/274 (0.36%)  0/128 (0.00%) 
Pregnancy  1  1/274 (0.36%)  0/128 (0.00%) 
Psychiatric disorders     
Depression  1  1/274 (0.36%)  0/128 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  1/274 (0.36%)  0/128 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  15/274 (5.47%)  14/128 (10.94%) 
Pleuritic pain  1  1/274 (0.36%)  0/128 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  0/274 (0.00%)  1/128 (0.78%) 
Urticaria  1  0/274 (0.00%)  1/128 (0.78%) 
Vascular disorders     
Haematoma  1  1/274 (0.36%)  0/128 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OAT + Omalizumab Optimized Asthma Treatment (OAT)
Affected / at Risk (%) Affected / at Risk (%)
Total   140/274 (51.09%)   65/128 (50.78%) 
Infections and infestations     
Bronchitis  1  13/274 (4.74%)  7/128 (5.47%) 
Influenza  1  18/274 (6.57%)  4/128 (3.13%) 
Lower respiratory tract infection  1  16/274 (5.84%)  8/128 (6.25%) 
Nasopharyngitis  1  38/274 (13.87%)  9/128 (7.03%) 
Sinusitis  1  10/274 (3.65%)  7/128 (5.47%) 
Upper respiratory tract infection  1  17/274 (6.20%)  6/128 (4.69%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  14/274 (5.11%)  0/128 (0.00%) 
Nervous system disorders     
Headache  1  33/274 (12.04%)  9/128 (7.03%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  82/274 (29.93%)  51/128 (39.84%) 
Cough  1  14/274 (5.11%)  4/128 (3.13%) 
Oropharyngeal pain  1  14/274 (5.11%)  1/128 (0.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 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.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00264849     History of Changes
Other Study ID Numbers: CIGE025A2425
First Submitted: December 12, 2005
First Posted: December 13, 2005
Results First Submitted: December 3, 2010
Results First Posted: July 25, 2011
Last Update Posted: June 29, 2018