A Phase 3 interventional study of omalizumab and Placebo in Asthma, sponsored by Novartis Pharmaceuticals. Completed at 10 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-07-20.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Basic science
This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.
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This study's enrollment of 79 is close to the median of 83 across 2,752 interventional studies indexed under Asthma.
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Severe persistent asthma with the following characteristics:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
Drug: omalizumab
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
Drug: Placebo
Omalizumab was supplied in 5mL vials with solution for subcutaneous injection.
Placebo was supplied in vials with solution for subcutaneous injection.
Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
Time frame: Baseline and 16 weeks
Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
Time frame: Baseline and 16 weeks
Change in Fractional Exhaled Nitric Oxide (FeNO)
FeNO was measured at baseline, and after 4, 8, 12 and 16 weeks of treatment. Absolute change in FeNO was expressed at each time point versus baseline value.
Time frame: Baseline and 4, 8, 12 and 16 weeks
Change From Baseline in Induced Sputum Eosinophil Count
The induced sputum eosinophil count was measured in a subset of patients in selected centers. Sputum samples were collected at screening and Week 16. Sputum eosinophil count was expressed as a percentage of total nonsquamous cells. Absolute change in sputum eosinophil count was expressed versus baseline value.
Time frame: Baseline and 16 weeks
Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)
The shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-agonist use) between 0 and 6 (0 = no impairment; 6 = maximum impairment) and a total score between 0 and 6 (subscores mean value). Absolute change in total score and subscores count was expressed versus baseline value. A decrease in score indicates improvement.
Time frame: Baseline and 16 weeks
Change From Baseline in Nasal Symptom Global Score and Individual Components
Nasal symptom score calculated from six scales assessing the nasal symptom severity (sneezing, runny nose, congestion, itchy nose, postnasal drip and nasal symptoms overall). These six scores were rated on a scale from 1 to 7, with 7 being the worst rating. Absolute changes in these six scores were expressed versus baseline values. A negative change indicates improvement. The range of the global score was from 1 to 7, since this is the mean value of all the subscores.
Time frame: Baseline and 16 weeks
Physician and Patient Global Evaluation of Treatment Effectiveness
The GETE is an assessment of asthma symptoms controlled in response to asthma treatment. The evaluation was performed independently by both investigator and patient using the same 5 point scale. The scale points are: excellent, good, moderate, poor and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.
Time frame: 16 weeks
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks
Spirometry was conducted according to internationally accepted standards. At least three maneuvers were performed at each sampling timepoint. The FEV1 recorded was taken from the maneuver obtained from the single best test curve. The best test curve was defined as the spirogram that gave the largest FEV1.
Time frame: Baseline and 16 weeks
Number of Patients With at Least One Asthma-related Event Over 16 Weeks
Asthma-related events were: unscheduled medical visits, emergency room visits and hospitalizations. Details of exacerbations requiring oral or IV corticosteroids were recorded at each visit.
Time frame: 16 weeks
| Milestone | Omalizumab | Placebo |
|---|---|---|
| Started | 20 | 21 |
| Completed | 20 | 20 |
| Not completed | 0 | 1 |
| Withdrew: Administrative problems | 0 | 1 |
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
| Percent change in MFI | Omalizumab | Placebo |
|---|---|---|
| Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils | -84.4 ± 17.80 | 27.7 ± 87.90 |
FeNO was measured at baseline, and after 4, 8, 12 and 16 weeks of treatment. Absolute change in FeNO was expressed at each time point versus baseline value.
| parts per billion (ppb) | Omalizumab | Placebo |
|---|---|---|
| Week 4 (N = 19, 19) | 2.5 ± 21.28 | -5.9 ± 29.72 |
| Week 8 (N = 18, 20) | 4.3 ± 25.48 | -7.4 ± 30.19 |
| Week 12 (N = 19, 18) | 1.0 ± 17.29 | 1.3 ± 30.26 |
| Week 16 (N = 18, 19) | 2.4 ± 18.19 | 0.7 ± 17.57 |
The induced sputum eosinophil count was measured in a subset of patients in selected centers. Sputum samples were collected at screening and Week 16. Sputum eosinophil count was expressed as a percentage of total nonsquamous cells. Absolute change in sputum eosinophil count was expressed versus baseline value.
| Percentage of total nonsquamous cells | Omalizumab | Placebo |
|---|---|---|
| Change From Baseline in Induced Sputum Eosinophil Count | -10.2 ± 32.38 | 2.2 ± 10.94 |
The shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-agonist use) between 0 and 6 (0 = no impairment; 6 = maximum impairment) and a total score between 0 and 6 (subscores mean value). Absolute change in total score and subscores count was expressed versus baseline value. A decrease in score indicates improvement.
| Score units | Omalizumab | Placebo |
|---|---|---|
| Total score | -0.5 ± 0.98 | -0.5 ± 1.43 |
| Nighttime waking | 0.1 ± 1.61 | -0.8 ± 1.69 |
| Symptoms on waking | -0.6 ± 1.32 | -0.9 ± 1.73 |
| Activity limitation | -0.7 ± 1.34 | -0.5 ± 1.94 |
| Shortness of breath | -0.9 ± 1.29 | -0.6 ± 1.75 |
| Wheeze (N = 19, 21) | -0.8 ± 1.62 | -0.3 ± 1.79 |
| Use of rescue short-acting β2-agonist | -0.3 ± 0.57 | 0.3 ± 1.45 |
Nasal symptom score calculated from six scales assessing the nasal symptom severity (sneezing, runny nose, congestion, itchy nose, postnasal drip and nasal symptoms overall). These six scores were rated on a scale from 1 to 7, with 7 being the worst rating. Absolute changes in these six scores were expressed versus baseline values. A negative change indicates improvement. The range of the global score was from 1 to 7, since this is the mean value of all the subscores.
| Score units | Omalizumab | Placebo |
|---|---|---|
| Global score | -0.8 ± 0.74 | -0.3 ± 1.38 |
| Sneezing | -1.1 ± 1.10 | -0.4 ± 1.12 |
| Runny nose | -0.9 ± 1.20 | -0.6 ± 1.83 |
| Congestion | -0.6 ± 1.39 | -0.7 ± 2.24 |
| Itchy nose | -0.4 ± 0.84 | 0.1 ± 1.92 |
| Postnasal drip | -0.6 ± 1.50 | 0.3 ± 1.37 |
| Nasal symptoms overall | -1.2 ± 1.44 | -0.2 ± 1.81 |
The GETE is an assessment of asthma symptoms controlled in response to asthma treatment. The evaluation was performed independently by both investigator and patient using the same 5 point scale. The scale points are: excellent, good, moderate, poor and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.
| Participants | Omalizumab | Placebo |
|---|---|---|
| Physician's evaluation - Excellent | 2 | 1 |
| Physician's evaluation - Good | 6 | 4 |
| Physician's evaluation - Moderate | 3 | 8 |
| Physician's evaluation - Poor | 9 | 6 |
| Physician's evaluation - Worsening | 0 | 2 |
| Patient's evaluation - Excellent | 2 | 0 |
| Patient's evaluation - Good | 7 | 5 |
| Patient's evaluation - Moderate | 6 | 9 |
| Patient's evaluation - Poor | 5 | 4 |
| Patient's evaluation - Worsening | 0 | 2 |
Spirometry was conducted according to internationally accepted standards. At least three maneuvers were performed at each sampling timepoint. The FEV1 recorded was taken from the maneuver obtained from the single best test curve. The best test curve was defined as the spirogram that gave the largest FEV1.
| Liters | Omalizumab | Placebo |
|---|---|---|
| Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks | 0.25 ± 0.38 | 0.00 ± 0.20 |
Asthma-related events were: unscheduled medical visits, emergency room visits and hospitalizations. Details of exacerbations requiring oral or IV corticosteroids were recorded at each visit.
| Participants | Omalizumab | Placebo |
|---|---|---|
| Number of Patients With at Least One Asthma-related Event Over 16 Weeks | 9 | 11 |
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
| Percent change in MFI | Omalizumab | Placebo |
|---|---|---|
| Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells | -56.7 ± 19.74 | 24.8 ± 111.71 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omalizumab | — | 2/20 (10%) | 16/20 (80%) |
| Placebo | — | 1/21 (4.8%) | 16/21 (76.2%) |
| Event | Omalizumab | Placebo |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 2/20 | 0/21 |
| Myocardial infarctionCardiac disorders | 0/20 | 1/21 |
| Event | Omalizumab | Placebo |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 6/20 | 12/21 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/20 | 2/21 |
| RhinitisInfections and infestations | 3/20 | 0/21 |
| Back painMusculoskeletal and connective tissue disorders | 3/20 | 0/21 |
| HeadacheNervous system disorders | 3/20 | 3/21 |
| TachycardiaCardiac disorders | 2/20 | 0/21 |
| Oedema peripheralGeneral disorders | 2/20 | 0/21 |
| BronchitisInfections and infestations | 2/20 | 2/21 |
| ParaesthesiaNervous system disorders | 2/20 | 0/21 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/20 | 1/21 |
| Age Continuous(years) | Omalizumab | Placebo | Total |
|---|---|---|---|
| Mean | 55.0 ± 9.67 | 54.6 ± 12.78 | 54.8 ± 11.23 |
| Sex: Female, Male(Participants) | Omalizumab | Placebo | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 7 | 8 | 15 |
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Novartis Pharmaceuticals