A Phase 4 interventional study of Omalizumab and placebo in Asthma, sponsored by Novartis Pharmaceuticals. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-08.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Treatment
The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting Beta-2 agonist.
Double blind placebo controlled study to assess the expression of IgE on blood basophils and dendritic cells in patients with uncontrolled, severe, persistent allergic asthma after a 16-week Omalizumab treatment.
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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.
Drug: Omalizumab
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
Drug: placebo
Omalizumab was supplied as a sterile, freeze dried preparation, to be reconstituted to deliver 150mg of omalizumab. Each vial was reconstituted with 1.4ml of sterile water for injection. The appropriate dose and dosing frequency of omalizumab were determined by baseline total IgE and body weight. A dosing table was used following the European Summary of Product Characteristics (SmPC) of omalizumab.
Placebo was a physiological salt solution, administered according to the same administration scheme to respect the same dosing frequency and injected volume.
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
Blood was drawn from participants at baseline and at Week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.
Time frame: Baseline and Week 16
Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo
Blood was drawn from participants at baseline and at week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.
Time frame: Baseline and Week 16
Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment
Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.
Time frame: Baseline, Weeks 4, 8, 12 and 16
Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment
Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Change From Baseline in the Number of Days With Asthma Symptoms Per Week
Participants maintained a diary to record the number of days with daytime asthma symptoms per week. This analysis compares the mean number of days per week with asthma symptoms during the 4-week screening period prior to randomization with the mean number of days per wek with asthma symptoms in the last 4 weeks of study treatment (Weeks 12 -16).
Time frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Change From Baseline in the Number of Puffs of Rescue Medication Per Week
Participants maintained a diary to record the daytime number of puffs of rescue Short-acting B2 agonist (SABA) used to treat asthma symptoms per week. This analysis compares the mean number of puffs of rescue medication per week during the 4 week screening period prior to randomization to the mean number of puffs per week during the last 4 weeks on study treatment (Weeks 12 - 16).
Time frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Change From Baseline in the Number of Nights With Awakenings Per Week
Participants maintained a diary to record the number of nights with awakenings due to asthma symptoms per week. For this analysis, the mean number of nights with awakenings per week during the 4 week screening period prior to randomization was compared with the mean number of nights with awakenings per week during the last 4 weeks of study treatment (Weeks 12 - 16).
Time frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week
Impairment was defined as days with physical activity considered as limited (or "not normal") according to patient's assessment and was recorded in a patient daily diary. For this analysis, the mean number of days with impairment per week during the 4 week screening period prior to randomization was compared with the mean number of days with impairment per week during the last 4 weeks on study treatment (Weeks 12 - 16).
Time frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms
Participants maintained a diary to record the number of days with absence from school or work due to asthma symptoms. For this analysis, the number of days with absence from school or work in the four weeks prior to randomization (screening period) were compared with the number of absence days during the last 4 weeks on study treatment (Weeks 12 - 16).
Time frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Change From Baseline in the Number of Days With Hospitalizations
Participants maintained a diary to record the number of days with hospitalizations during the study. For this analysis, the number of days with hospitalizations during the screening period (4 weeks prior to randomization) was compared with the number of days with hospitalizations during the last 4 weeks on study treatment (Weeks 12 - 16).
Time frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Change From Baseline in the Number of Unscheduled Clinic Visits
Participants maintained a diary to record the number of unscheduled clinic visits during the study. For this analysis, the number of unscheduled visits during the 4 week screening period prior to randomization is compared with the number of unscheduled visits during the last 4 weeks on treatment (Weeks 12 - 16).
Time frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF)
Peak Expiratory Flow (PEF) was measured every morning using a peak flow meter, and was recorded in the patient diary. For this analysis, the mean morning PEF during the 4-week screening period prior to randomizaton is compared with the mean morning PEF during the last 4 weeks of study treatment (Weeks 12 - 16).
Time frame: Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)
Physician's Overall Assessment of Treatment Effectiveness
The Physician's overall assessment of treatment effectiveness was graded 1-5 as 1 = Excellent asthma control (complete control) 2 = Good asthma control (marked improvement) 3 = Moderate asthma control (discernible, but limited improvement) 4 = Poor asthma control (no appreciable change) 5 = Very poor asthma control (worsening)
Time frame: After 16 weeks of treatment
| Milestone | Omalizumab | Placebo |
|---|---|---|
| Started | 20 | 11 |
| Completed | 17 | 8 |
| Not completed | 3 | 3 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Protocol violation | 1 | 1 |
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.
| percent change in FcεRI expression | Omalizumab | Placebo |
|---|---|---|
| % Change in Basophils expressing FcεRI | -0.1 ± 8.39 | 3.9 ± 7.00 |
| % Change in Dendritic cells expressing FcεRI | -5.9 ± 27.14 | 14.8 ± 22.80 |
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.
| percent change in cells expressing FcεRI | Omalizumab | Placebo |
|---|---|---|
| % change Basophils expressing FcεRI at Week 4 | 1.9 ± 7.89 | -5.2 ± 8.46 |
| % change Basophils expressing FcεRI at Week 8 | 2.5 ± 8.60 | 0.9 ± 1.49 |
| % change Basophils expressing FcεRI at Week 12 | 3.7 ± 23.49 | -6.4 ± 11.92 |
| % change Basophils expressing FcεRI at Week 16 | 4.6 ± 9.40 | -1.4 ± 3.29 |
| % change Dendritic cells expressing FcεRI Week 4 | -16.1 ± 33.54 | -4.7 ± 17.73 |
| % change Dendritic cells expressing FcεRI Week 8 | -1.9 ± 14.66 | 6.2 ± 7.03 |
| % change Dendritic cells expressing FcεRI Week 12 | -10.3 ± 19.62 | -2.8 ± 27.98 |
| % change Dendritic cells expressing FcεRI Week 16 | -9.8 ± 11.07 | 23.0 ± 24.70 |
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.
| % change in fluorescence intensity | Omalizumab | Placebo |
|---|---|---|
| % change on basophils at Week 4 | -85.1 ± 6.09 | -45.8 ± 41.14 |
| % change on basophils at Week 8 | -81.0 ± 9.08 | -11.5 ± 40.83 |
| % change on basophils at Week 12 | -86.8 ± 6.36 | -24.2 ± 60.18 |
| % change on basophils at Week 16 | -88.6 ± 4.39 | 54.2 ± 11.71 |
| % change on dendritic cells at Week 4 | -38.6 ± 42.76 | -36.6 ± 27.95 |
| % change on dendritic cells at Week 8 | -27.1 ± 40.13 | -12.2 ± 42.56 |
| % change on dendritic cells at Week 12 | -31.2 ± 60.61 | -14.1 ± 55.42 |
| % change on dendritic cells at Week 16 | -49.2 ± 30.21 | 47.1 ± 92.44 |
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).
| days per week | Omalizumab | Placebo |
|---|---|---|
| Baseline | 5.9 ± 1.71 | 4.5 ± 2.26 |
| Change from Baseline | -2.3 ± 2.77 | -0.9 ± 1.79 |
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.
| percent change in fluorescence intensity | Omalizumab | Placebo |
|---|---|---|
| % Change in Basophil fluorescence intensity | -77.5 ± 20.83 | 20.0 ± 76.70 |
| % Change in Dendritic cell fluorescence intensity | -41.4 ± 36.90 | 36.7 ± 101.66 |
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).
| puffs per week | Omalizumab | Placebo |
|---|---|---|
| Baseline | 19.7 ± 24.68 | 10.5 ± 13.43 |
| Change from Baseline | -2.0 ± 16.13 | -2.7 ± 7.75 |
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).
| nights with awakenings per week | Omalizumab | Placebo |
|---|---|---|
| Baseline | 2.5 ± 2.55 | 1.7 ± 2.15 |
| Change from Baseline | -1.2 ± 2.08 | -0.4 ± 1.31 |
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).
| days per week | Omalizumab | Placebo |
|---|---|---|
| Baseline | 4.9 ± 2.35 | 4.5 ± 2.41 |
| Change from Baseline | -1.6 ± 2.43 | -1.0 ± 2.53 |
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).
| days | Omalizumab | Placebo |
|---|---|---|
| Baseline | 2.7 ± 7.38 | 2.5 ± 8.44 |
| Change from Baseline | -0.9 ± 2.54 | 0.1 ± 0.30 |
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).
| days | Omalizumab | Placebo |
|---|---|---|
| Baseline | 0.0 ± 0.0 | 0.0 ± 0.0 |
| Change from Baseline | 0.0 ± 0.0 | 0.0 ± 0.0 |
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).
| unscheduled visits | Omalizumab | Placebo |
|---|---|---|
| Baseline | 0.2 ± 0.62 | 0.1 ± 0.30 |
| Change from Baseline | -0.1 ± 0.55 | 0.1 ± 0.54 |
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).
| liters per minute | Omalizumab | Placebo |
|---|---|---|
| Baseline | 303.5 ± 122.07 | 317.8 ± 77.37 |
| Change from Baseline | 9.9 ± 54.06 | 10.5 ± 28.8 |
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)
| participants | Omalizumab | Placebo |
|---|---|---|
| Excellent | 3 | 1 |
| Good | 5 | 2 |
| Moderate | 6 | 4 |
| Poor | 3 | 1 |
| Worsening | 0 | 1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omalizumab | — | 0/20 (0%) | 13/20 (65%) |
| Placebo | — | 1/11 (9.1%) | 7/11 (63.6%) |
| Event | Omalizumab | Placebo |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/20 | 1/11 |
| Event | Omalizumab | Placebo |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 11/20 | 4/11 |
| RhinitisInfections and infestations | 3/20 | 1/11 |
| HeadacheNervous system disorders | 3/20 | 1/11 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 2/20 | 1/11 |
| NauseaGastrointestinal disorders | 2/20 | 0/11 |
| ChillsGeneral disorders | 2/20 | 0/11 |
| FatigueGeneral disorders | 2/20 | 0/11 |
| Viral infectionInfections and infestations | 2/20 | 0/11 |
| Back painMusculoskeletal and connective tissue disorders | 2/20 | 0/11 |
| ConjunctivitisEye disorders | 1/20 | 1/11 |
| Age Continuous(years) | Omalizumab | Placebo | Total |
|---|---|---|---|
| Mean | 45.7 ± 13.30 | 50.6 ± 16.31 | 47.4 ± 14.37 |
| Sex: Female, Male(Participants) | Omalizumab | Placebo | Total |
|---|---|---|---|
| Female | 14 | 5 | 19 |
| Male | 6 | 6 | 12 |
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omalizumab