Trial Outcomes & Findings for Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma (NCT NCT00264849)
NCT ID: NCT00264849
Last Updated: 2018-06-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
406 participants
Primary outcome timeframe
Weeks 16 and 32
Results posted on
2018-06-29
Participant Flow
Participant milestones
| Measure |
OAT + Omalizumab
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.
|
Optimized Asthma Treatment (OAT)
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 Study
STARTED
|
275
|
131
|
|
Overall Study
COMPLETED
|
253
|
106
|
|
Overall Study
NOT COMPLETED
|
22
|
25
|
Reasons for withdrawal
| Measure |
OAT + Omalizumab
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.
|
Optimized Asthma Treatment (OAT)
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 Study
Adverse Event
|
7
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
11
|
|
Overall Study
Protocol Violation
|
5
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Administrative Problems
|
2
|
0
|
Baseline Characteristics
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Baseline characteristics by cohort
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
250 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 13.04 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 12.57 • n=7 Participants
|
45.7 years
STANDARD_DEVIATION 12.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
266 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 16 and 32Population: Modified Intent-to-Treat (mITT) was defined for efficacy analyses which included all randomized patients who had at least one post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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.
|
|---|---|---|
|
Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)
Number of responders at Wk 16
|
190 participants
|
29 participants
|
|
Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)
Participants available to assess persistency
|
187 participants
|
28 participants
|
|
Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)
Number of Persistent Responders at Weeks 16 and 32
|
171 participants
|
18 participants
|
|
Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)
Number of non-responders at Week 16
|
71 participants
|
64 participants
|
|
Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)
Participants to assess persistency of non respond
|
71 participants
|
63 participants
|
|
Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)
Number of Persistent Non-responders at Wks 16and32
|
44 participants
|
57 participants
|
SECONDARY outcome
Timeframe: Weeks 16 and 32Population: Modified Intent-to-Treat (mITT)
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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.
|
|---|---|---|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 16: Excellent
|
35 participants
|
1 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 16: Good
|
155 participants
|
28 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 16: Moderate
|
57 participants
|
24 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 16: Poor
|
13 participants
|
34 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 16: Worsening
|
1 participants
|
6 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 16: Missing
|
11 participants
|
35 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 16: Responders (excellent and good)
|
190 participants
|
29 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 16: Non-responders (moderate, poor, worse)
|
71 participants
|
64 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 32: Excellent
|
73 participants
|
1 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 32: Good
|
126 participants
|
24 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 32: Moderate
|
45 participants
|
31 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 32: Poor
|
13 participants
|
39 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 32: Worsening
|
2 participants
|
9 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 32: Missing
|
13 participants
|
24 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 32: Responders (excellent and good)
|
199 participants
|
25 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Week 32: Non-responders (moderate, poor, worse)
|
60 participants
|
79 participants
|
|
Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32
Responder at both weeks (Weeks 16 and 32)
|
171 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Weeks 16 and 32Population: Modified Intent-to-Treat (mITT)
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Investigator's GETE
|
62.9 percentage of participants
Interval 57.1 to 68.6
|
14.1 percentage of participants
Interval 8.0 to 20.1
|
SECONDARY outcome
Timeframe: Weeks 16 and 32Population: Modified Intent-to-Treat (mITT)
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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.
|
|---|---|---|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 32: Missing
|
13 participants
|
25 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 16: Excellent
|
54 participants
|
4 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 16: Good
|
139 participants
|
29 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 16: Moderate
|
53 participants
|
23 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 16: Poor
|
15 participants
|
33 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 16: Worsening
|
1 participants
|
5 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 16: Missing
|
10 participants
|
34 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 16: Responders (excellent and good)
|
193 participants
|
33 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 16:Non-responders (moderate, poor, worsening)
|
69 participants
|
61 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 32: Excellent
|
80 participants
|
2 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 32: Good
|
127 participants
|
27 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 32: Moderate
|
38 participants
|
28 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 32: Poor
|
12 participants
|
38 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 32: Worsening
|
2 participants
|
8 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 32: Responders (excellent and good)
|
207 participants
|
29 participants
|
|
Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32
Week 32: Non-responders (moderate, poor, worse)
|
52 participants
|
74 participants
|
SECONDARY outcome
Timeframe: Weeks 16 and 32Population: 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.
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Patient's GETE
|
63.2 percentage of participants
Interval 57.5 to 69.0
|
15.6 percentage of participants
Interval 9.3 to 21.9
|
SECONDARY outcome
Timeframe: Weeks 16 and 32Population: 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.
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).
Outcome measures
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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.
|
|---|---|---|
|
Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)
Week 16
|
68.4 percent predicted FEV1
Interval 66.2 to 70.5
|
64.8 percent predicted FEV1
Interval 61.8 to 67.8
|
|
Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)
Week 32
|
68.1 percent predicted FEV1
Interval 65.8 to 70.5
|
63.7 percent predicted FEV1
Interval 60.6 to 66.8
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 32Population: 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.
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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.
|
|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32
Week 16 (N=249,104)
|
-0.78 units on a scale
Interval -0.92 to -0.63
|
-0.11 units on a scale
Interval -0.31 to 0.1
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32
Week 32 (N=238,104)
|
-0.91 units on a scale
Interval -1.07 to -0.76
|
-0.04 units on a scale
Interval -0.26 to 0.17
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32
Last post-baseline (N=255,119)
|
-0.84 units on a scale
Interval -1.0 to -0.69
|
0.07 units on a scale
Interval -0.14 to 0.27
|
SECONDARY outcome
Timeframe: 32 WeeksPopulation: mITT
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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.
|
|---|---|---|
|
Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period
0 asthma exacerbations
|
183 participants
|
64 participants
|
|
Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period
1 asthma exacerbation
|
58 participants
|
35 participants
|
|
Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period
2 asthma exacerbations
|
18 participants
|
17 participants
|
|
Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period
3 asthma exacerbations
|
9 participants
|
6 participants
|
|
Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period
>= 4 asthma exacerbations
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 32 WeeksPopulation: Modified Intent-to-Treat (mITT)
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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.
|
|---|---|---|
|
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
0 combined visits/hospitalizations
|
226 participants
|
86 participants
|
|
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
1 combined visit/hospitalization
|
26 participants
|
12 participants
|
|
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
2 combined visits/hospitalizations
|
10 participants
|
17 participants
|
|
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
3 combined visits/hospitalizations
|
4 participants
|
8 participants
|
|
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
>= 4 combined visits/hospitalizations
|
6 participants
|
5 participants
|
|
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
Total number of combined visits/hospitalizations
|
92 participants
|
100 participants
|
SECONDARY outcome
Timeframe: Weeks 16 and 32Population: 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.
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=59 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=23 Participants
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.
|
|---|---|---|
|
Percent Change in Dose of Maintenance Systemic Steroids at Weeks 16 and 32
Week 16 (N=56,19)
|
-20.1 percent change
Standard Deviation 63.08
|
36.8 percent change
Standard Deviation 212.03
|
|
Percent Change in Dose of Maintenance Systemic Steroids at Weeks 16 and 32
Week 32 (N=59,23)
|
-45.0 percent change
Standard Deviation 50.22
|
18.3 percent change
Standard Deviation 85.13
|
SECONDARY outcome
Timeframe: Weeks 16 and 32Population: 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).
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=59 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=23 Participants
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.
|
|---|---|---|
|
Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32
Week 32 - Removed systemic steroids
|
19 participants
|
3 participants
|
|
Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32
Week 16 - Removed systemic steroids (N=56,19)
|
10 participants
|
2 participants
|
|
Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32
Week 16 - Decreased systemic steroids (N=56,19)
|
14 participants
|
2 participants
|
|
Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32
Week 16 - Maintained systemic steroids (N=56,19)
|
32 participants
|
15 participants
|
|
Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32
Week 32 - Decreased systemic steroids
|
18 participants
|
4 participants
|
|
Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32
Week 32 - Maintained systemic steroids
|
22 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 15, Week 31Population: 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.
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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.
|
|---|---|---|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Overall Score: Week 15
|
0.90 units on a scale
Interval 0.73 to 1.07
|
0.03 units on a scale
Interval -0.2 to 0.27
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Overall Score: Week 31
|
1.06 units on a scale
Interval 0.88 to 1.24
|
-0.07 units on a scale
Interval -0.31 to 0.17
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Symptom Score: Week 15
|
0.89 units on a scale
Interval 0.7 to 1.09
|
-0.05 units on a scale
Interval -0.31 to 0.22
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Symptom Score: Week 31
|
1.07 units on a scale
Interval 0.88 to 1.27
|
-0.07 units on a scale
Interval -0.34 to 0.19
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Activities Score: Week 15
|
0.87 units on a scale
Interval 0.7 to 1.04
|
0.03 units on a scale
Interval -0.2 to 0.26
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Activities Score: Week 31
|
1.08 units on a scale
Interval 0.91 to 1.26
|
-0.07 units on a scale
Interval -0.31 to 0.17
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Emotions Score: Week 15
|
0.98 units on a scale
Interval 0.78 to 1.18
|
0.20 units on a scale
Interval -0.07 to 0.48
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Emotions Score: Week 31
|
1.08 units on a scale
Interval 0.88 to 1.28
|
-0.07 units on a scale
Interval -0.34 to 0.19
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Enironmental Exposure Score: Week 15 (N=213,91)
|
0.84 units on a scale
Interval 0.66 to 1.02
|
0.10 units on a scale
Interval -0.15 to 0.34
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit
Enironmental Exposure Score: Week 31(N=223,96)
|
0.91 units on a scale
Interval 0.71 to 1.11
|
-0.01 units on a scale
Interval -0.29 to 0.26
|
SECONDARY outcome
Timeframe: Baseline, Week 15, Week 31Population: Modified Intent-to-Treat with N count as noted in category 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).
Outcome measures
| Measure |
OAT + Omalizumab
n=272 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=128 Participants
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.
|
|---|---|---|
|
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
EQ-5D Utility Index Score: Week 15 (N=212,90)
|
0.071 units on a scale
Interval 0.038 to 0.105
|
0.002 units on a scale
Interval -0.044 to 0.049
|
|
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
EQ-5D Utility Index Score: Week 31 (N=194,81)
|
0.091 units on a scale
Interval 0.051 to 0.132
|
0.064 units on a scale
Interval 0.008 to 0.121
|
|
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
Health State Assessment: Week 15 (N=211,89)
|
8.2 units on a scale
Interval 4.7 to 11.8
|
-0.4 units on a scale
Interval -5.4 to 4.6
|
|
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
Health State Assessment: Week 31 (N=194,80)
|
9.3 units on a scale
Interval 5.2 to 13.4
|
-2.8 units on a scale
Interval -8.5 to 3.0
|
SECONDARY outcome
Timeframe: Baseline and Week 31Population: 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.
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.
Outcome measures
| Measure |
OAT + Omalizumab
n=78 Participants
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.
|
Optimized Asthma Treatment (OAT)
n=32 Participants
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.
|
|---|---|---|
|
Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems
Baseline
|
41.3 percent impairment
Standard Deviation 26.19
|
39.4 percent impairment
Standard Deviation 24.91
|
|
Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems
Week 31
|
20.5 percent impairment
Standard Deviation 24.28
|
40.3 percent impairment
Standard Deviation 27.97
|
|
Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems
Change from baseline at Week 31
|
-20.8 percent impairment
Standard Deviation 26.38
|
0.8 percent impairment
Standard Deviation 30.34
|
Adverse Events
OAT + Omalizumab
Serious events: 29 serious events
Other events: 140 other events
Deaths: 0 deaths
Optimized Asthma Treatment (OAT)
Serious events: 17 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OAT + Omalizumab
n=274 participants at risk
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.
|
Optimized Asthma Treatment (OAT)
n=128 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.36%
1/274
|
0.00%
0/128
|
|
Endocrine disorders
Goitre
|
0.36%
1/274
|
0.00%
0/128
|
|
Endocrine disorders
Hyperparathyroidism
|
0.36%
1/274
|
0.00%
0/128
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/274
|
0.78%
1/128
|
|
General disorders
Chest pain
|
0.36%
1/274
|
0.00%
0/128
|
|
General disorders
Oedema peripheral
|
0.36%
1/274
|
0.00%
0/128
|
|
General disorders
Polyp
|
0.00%
0/274
|
0.78%
1/128
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/274
|
0.78%
1/128
|
|
Infections and infestations
Bronchitis
|
0.00%
0/274
|
1.6%
2/128
|
|
Infections and infestations
Gastroenteritis
|
0.36%
1/274
|
0.00%
0/128
|
|
Infections and infestations
Lower respiratory tract infection
|
0.36%
1/274
|
0.78%
1/128
|
|
Infections and infestations
Orchitis
|
0.36%
1/274
|
0.00%
0/128
|
|
Infections and infestations
Pneumonia
|
0.36%
1/274
|
0.00%
0/128
|
|
Infections and infestations
Respiratory tract infection viral
|
0.36%
1/274
|
0.00%
0/128
|
|
Infections and infestations
Urosepsis
|
0.36%
1/274
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.73%
2/274
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Contusion
|
0.73%
2/274
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.36%
1/274
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.36%
1/274
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.1%
3/274
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.36%
1/274
|
0.00%
0/128
|
|
Metabolism and nutrition disorders
Dehydration
|
0.36%
1/274
|
0.00%
0/128
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.36%
1/274
|
0.00%
0/128
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/274
|
0.78%
1/128
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.36%
1/274
|
0.00%
0/128
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/274
|
0.78%
1/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.36%
1/274
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.36%
1/274
|
0.00%
0/128
|
|
Nervous system disorders
Headache
|
0.36%
1/274
|
0.00%
0/128
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.36%
1/274
|
0.00%
0/128
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.36%
1/274
|
0.00%
0/128
|
|
Psychiatric disorders
Depression
|
0.36%
1/274
|
0.00%
0/128
|
|
Renal and urinary disorders
Renal failure acute
|
0.36%
1/274
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.5%
15/274
|
10.9%
14/128
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.36%
1/274
|
0.00%
0/128
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/274
|
0.78%
1/128
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/274
|
0.78%
1/128
|
|
Vascular disorders
Haematoma
|
0.36%
1/274
|
0.00%
0/128
|
Other adverse events
| Measure |
OAT + Omalizumab
n=274 participants at risk
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.
|
Optimized Asthma Treatment (OAT)
n=128 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
4.7%
13/274
|
5.5%
7/128
|
|
Infections and infestations
Influenza
|
6.6%
18/274
|
3.1%
4/128
|
|
Infections and infestations
Lower respiratory tract infection
|
5.8%
16/274
|
6.2%
8/128
|
|
Infections and infestations
Nasopharyngitis
|
13.9%
38/274
|
7.0%
9/128
|
|
Infections and infestations
Sinusitis
|
3.6%
10/274
|
5.5%
7/128
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
17/274
|
4.7%
6/128
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
14/274
|
0.00%
0/128
|
|
Nervous system disorders
Headache
|
12.0%
33/274
|
7.0%
9/128
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
29.9%
82/274
|
39.8%
51/128
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
14/274
|
3.1%
4/128
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
14/274
|
0.78%
1/128
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER