Trial Outcomes & Findings for Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma (NCT NCT00454051)
NCT ID: NCT00454051
Last Updated: 2011-08-08
Results Overview
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.
COMPLETED
PHASE4
31 participants
Baseline and Week 16
2011-08-08
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
11
|
|
Overall Study
COMPLETED
|
17
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma
Baseline characteristics by cohort
| Measure |
Omalizumab
n=20 Participants
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
n=11 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
45.7 years
STANDARD_DEVIATION 13.30 • n=99 Participants
|
50.6 years
STANDARD_DEVIATION 16.31 • n=107 Participants
|
47.4 years
STANDARD_DEVIATION 14.37 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: 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.
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.
Outcome measures
| Measure |
Omalizumab
n=16 Participants
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
n=11 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
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
% Change in Dendritic cells expressing FcεRI
|
-5.9 percent change in FcεRI expression
Standard Deviation 27.14
|
14.8 percent change in FcεRI expression
Standard Deviation 22.80
|
|
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
% Change in Basophils expressing FcεRI
|
-0.1 percent change in FcεRI expression
Standard Deviation 8.39
|
3.9 percent change in FcεRI expression
Standard Deviation 7.00
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: 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.
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.
Outcome measures
| Measure |
Omalizumab
n=16 Participants
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
n=11 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo
% Change in Basophil fluorescence intensity
|
-77.5 percent change in fluorescence intensity
Standard Deviation 20.83
|
20.0 percent change in fluorescence intensity
Standard Deviation 76.70
|
|
Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo
% Change in Dendritic cell fluorescence intensity
|
-41.4 percent change in fluorescence intensity
Standard Deviation 36.90
|
36.7 percent change in fluorescence intensity
Standard Deviation 101.66
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12 and 16Population: A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.
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.
Outcome measures
| Measure |
Omalizumab
n=8 Participants
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
n=4 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change Basophils expressing FcεRI at Week 4
|
1.9 percent change in cells expressing FcεRI
Standard Deviation 7.89
|
-5.2 percent change in cells expressing FcεRI
Standard Deviation 8.46
|
|
Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change Basophils expressing FcεRI at Week 8
|
2.5 percent change in cells expressing FcεRI
Standard Deviation 8.60
|
0.9 percent change in cells expressing FcεRI
Standard Deviation 1.49
|
|
Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change Basophils expressing FcεRI at Week 12
|
3.7 percent change in cells expressing FcεRI
Standard Deviation 23.49
|
-6.4 percent change in cells expressing FcεRI
Standard Deviation 11.92
|
|
Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change Basophils expressing FcεRI at Week 16
|
4.6 percent change in cells expressing FcεRI
Standard Deviation 9.40
|
-1.4 percent change in cells expressing FcεRI
Standard Deviation 3.29
|
|
Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change Dendritic cells expressing FcεRI Week 4
|
-16.1 percent change in cells expressing FcεRI
Standard Deviation 33.54
|
-4.7 percent change in cells expressing FcεRI
Standard Deviation 17.73
|
|
Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change Dendritic cells expressing FcεRI Week 8
|
-1.9 percent change in cells expressing FcεRI
Standard Deviation 14.66
|
6.2 percent change in cells expressing FcεRI
Standard Deviation 7.03
|
|
Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change Dendritic cells expressing FcεRI Week 12
|
-10.3 percent change in cells expressing FcεRI
Standard Deviation 19.62
|
-2.8 percent change in cells expressing FcεRI
Standard Deviation 27.98
|
|
Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change Dendritic cells expressing FcεRI Week 16
|
-9.8 percent change in cells expressing FcεRI
Standard Deviation 11.07
|
23.0 percent change in cells expressing FcεRI
Standard Deviation 24.70
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, and 16Population: A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.
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.
Outcome measures
| Measure |
Omalizumab
n=8 Participants
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
n=4 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change on basophils at Week 4
|
-85.1 % change in fluorescence intensity
Standard Deviation 6.09
|
-45.8 % change in fluorescence intensity
Standard Deviation 41.14
|
|
Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change on basophils at Week 8
|
-81.0 % change in fluorescence intensity
Standard Deviation 9.08
|
-11.5 % change in fluorescence intensity
Standard Deviation 40.83
|
|
Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change on basophils at Week 12
|
-86.8 % change in fluorescence intensity
Standard Deviation 6.36
|
-24.2 % change in fluorescence intensity
Standard Deviation 60.18
|
|
Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change on basophils at Week 16
|
-88.6 % change in fluorescence intensity
Standard Deviation 4.39
|
54.2 % change in fluorescence intensity
Standard Deviation 11.71
|
|
Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change on dendritic cells at Week 4
|
-38.6 % change in fluorescence intensity
Standard Deviation 42.76
|
-36.6 % change in fluorescence intensity
Standard Deviation 27.95
|
|
Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change on dendritic cells at Week 8
|
-27.1 % change in fluorescence intensity
Standard Deviation 40.13
|
-12.2 % change in fluorescence intensity
Standard Deviation 42.56
|
|
Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change on dendritic cells at Week 12
|
-31.2 % change in fluorescence intensity
Standard Deviation 60.61
|
-14.1 % change in fluorescence intensity
Standard Deviation 55.42
|
|
Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment
% change on dendritic cells at Week 16
|
-49.2 % change in fluorescence intensity
Standard Deviation 30.21
|
47.1 % change in fluorescence intensity
Standard Deviation 92.44
|
SECONDARY outcome
Timeframe: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)Population: 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.
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).
Outcome measures
| Measure |
Omalizumab
n=20 Participants
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
n=11 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the Number of Days With Asthma Symptoms Per Week
Baseline
|
5.9 days per week
Standard Deviation 1.71
|
4.5 days per week
Standard Deviation 2.26
|
|
Change From Baseline in the Number of Days With Asthma Symptoms Per Week
Change from Baseline
|
-2.3 days per week
Standard Deviation 2.77
|
-0.9 days per week
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)Population: 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.
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).
Outcome measures
| Measure |
Omalizumab
n=20 Participants
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
n=11 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the Number of Puffs of Rescue Medication Per Week
Baseline
|
19.7 puffs per week
Standard Deviation 24.68
|
10.5 puffs per week
Standard Deviation 13.43
|
|
Change From Baseline in the Number of Puffs of Rescue Medication Per Week
Change from Baseline
|
-2.0 puffs per week
Standard Deviation 16.13
|
-2.7 puffs per week
Standard Deviation 7.75
|
SECONDARY outcome
Timeframe: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)Population: 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.
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).
Outcome measures
| Measure |
Omalizumab
n=20 Participants
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
n=11 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the Number of Nights With Awakenings Per Week
Baseline
|
2.5 nights with awakenings per week
Standard Deviation 2.55
|
1.7 nights with awakenings per week
Standard Deviation 2.15
|
|
Change From Baseline in the Number of Nights With Awakenings Per Week
Change from Baseline
|
-1.2 nights with awakenings per week
Standard Deviation 2.08
|
-0.4 nights with awakenings per week
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)Population: 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.
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).
Outcome measures
| Measure |
Omalizumab
n=20 Participants
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
n=11 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week
Baseline
|
4.9 days per week
Standard Deviation 2.35
|
4.5 days per week
Standard Deviation 2.41
|
|
Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week
Change from Baseline
|
-1.6 days per week
Standard Deviation 2.43
|
-1.0 days per week
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)Population: 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.
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).
Outcome measures
| Measure |
Omalizumab
n=20 Participants
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
n=11 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms
Baseline
|
2.7 days
Standard Deviation 7.38
|
2.5 days
Standard Deviation 8.44
|
|
Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms
Change from Baseline
|
-0.9 days
Standard Deviation 2.54
|
0.1 days
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)Population: 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.
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).
Outcome measures
| Measure |
Omalizumab
n=20 Participants
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
n=11 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the Number of Days With Hospitalizations
Baseline
|
0.0 days
Standard Deviation 0.0
|
0.0 days
Standard Deviation 0.0
|
|
Change From Baseline in the Number of Days With Hospitalizations
Change from Baseline
|
0.0 days
Standard Deviation 0.0
|
0.0 days
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)Population: 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.
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).
Outcome measures
| Measure |
Omalizumab
n=20 Participants
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
n=11 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the Number of Unscheduled Clinic Visits
Baseline
|
0.2 unscheduled visits
Standard Deviation 0.62
|
0.1 unscheduled visits
Standard Deviation 0.30
|
|
Change From Baseline in the Number of Unscheduled Clinic Visits
Change from Baseline
|
-0.1 unscheduled visits
Standard Deviation 0.55
|
0.1 unscheduled visits
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)Population: 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.
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).
Outcome measures
| Measure |
Omalizumab
n=20 Participants
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
n=11 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF)
Baseline
|
303.5 liters per minute
Standard Deviation 122.07
|
317.8 liters per minute
Standard Deviation 77.37
|
|
Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF)
Change from Baseline
|
9.9 liters per minute
Standard Deviation 54.06
|
10.5 liters per minute
Standard Deviation 28.8
|
SECONDARY outcome
Timeframe: After 16 weeks of treatmentPopulation: 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.
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)
Outcome measures
| Measure |
Omalizumab
n=17 Participants
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
n=9 Participants
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Physician's Overall Assessment of Treatment Effectiveness
Excellent
|
3 participants
|
1 participants
|
|
Physician's Overall Assessment of Treatment Effectiveness
Good
|
5 participants
|
2 participants
|
|
Physician's Overall Assessment of Treatment Effectiveness
Moderate
|
6 participants
|
4 participants
|
|
Physician's Overall Assessment of Treatment Effectiveness
Poor
|
3 participants
|
1 participants
|
|
Physician's Overall Assessment of Treatment Effectiveness
Worsening
|
0 participants
|
1 participants
|
Adverse Events
Omalizumab
Placebo
Serious adverse events
| Measure |
Omalizumab
n=20 participants at risk
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
n=11 participants at risk
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/20
|
9.1%
1/11
|
Other adverse events
| Measure |
Omalizumab
n=20 participants at risk
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
n=11 participants at risk
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
5.0%
1/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
1/20
|
0.00%
0/11
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
2/20
|
9.1%
1/11
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20
|
0.00%
0/11
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20
|
0.00%
0/11
|
|
General disorders
Chills
|
10.0%
2/20
|
0.00%
0/11
|
|
General disorders
Fatigue
|
10.0%
2/20
|
0.00%
0/11
|
|
Infections and infestations
Acute sinusitis
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20
|
9.1%
1/11
|
|
Infections and infestations
Influenza
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20
|
9.1%
1/11
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/20
|
9.1%
1/11
|
|
Infections and infestations
Rhinitis
|
15.0%
3/20
|
9.1%
1/11
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
Tonsillitis
|
5.0%
1/20
|
0.00%
0/11
|
|
Infections and infestations
Viral infection
|
10.0%
2/20
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20
|
0.00%
0/11
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20
|
9.1%
1/11
|
|
Nervous system disorders
Headache
|
15.0%
3/20
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
55.0%
11/20
|
36.4%
4/11
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/20
|
9.1%
1/11
|
Additional Information
Study Director
Novartis Pharmaceuticals
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