A Phase 4 interventional study of omalizumab at a dose of 0.016mg/kg/IU/mL and Placebo in Allergic Asthma, sponsored by Novartis Pharmaceuticals. Completed at 16 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-01-18.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment
This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists. This study will also investigate the correlation between systemic and pulmonary inflammation, and the correlation between clinical outcomes and changes within the tissue, to assist in the future identification of patients with tissue eosinophilia and their response to treatment, without the need for invasive bronchoscopy.
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 36 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied.
Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
Drug: omalizumab at a dose of 0.016mg/kg/IU/mL
Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
Drug: Placebo
Change From Baseline in Total Subepithelial Eosinophils at the End of Week 78 (End of Treatment)
The primary variable of change from baseline in total epithelia eosinophils at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
Time frame: Baseline, at end of week 78
Change From Baseline in Sub-epithelial Cell Count of Mast Cells Following 78 Weeks Treatment, as Assessed Biopsy Samples
The variable of change from baseline in Sub-epithelial cell count of mast cells at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
Time frame: Baseline, at end of week 78
Change From Baseline in Sub-epithelial CD4+ T-lymphocytes Following 78 Weeks Treatment, as Assessed Biopsy Samples
The variable of change from baseline in Sub-epithelial CD4+ T-lymphocytes at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
Time frame: Baseline, at end of week 78
Change From Baseline in Thickness of the Lamina Reticularis Following 78 Weeks Treatment, as Assessed Biopsy Samples
The variable of change from baseline in thickness of the lamina reticularis at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
Time frame: Baseline, at end of week 78
Number of Participants With Adverse Events, Serious Adverse Events and Death as an Assessment of Safety and Tolerability of 78 Weeks Therapy
Time frame: 78 weeks
| Milestone | Omalizumab | Placebo |
|---|---|---|
| Started | 23 | 13 |
| Intent to treat (itt) population | 23 | 12 |
| Completed | 22 | 12 |
| Not completed | 1 | 1 |
| Withdrew: Adminstrative problem | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
The primary variable of change from baseline in total epithelia eosinophils at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
| cells/mm^2 | Omalizumab | Placebo |
|---|---|---|
| Responder (n= 9, 3) | -5.807 ± 13.921 | -5.890 ± 9.128 |
| Non-responder (n = 8, 8) | 1.555 ± 11.065 | -5.626 ± 15.816 |
The variable of change from baseline in Sub-epithelial cell count of mast cells at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
| cells/mm^2 | Omalizumab | Placebo |
|---|---|---|
| Responder (n= 9, 3) | -1.392 ± 13.123 | 5.840 ± 19.809 |
| Non-responder (n= 8, 8) | 10.140 ± 10.266 | 1.114 ± 18.397 |
The variable of change from baseline in Sub-epithelial CD4+ T-lymphocytes at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
| cells/mm^2 | Omalizumab | Placebo |
|---|---|---|
| Responder (n= 9, 3) | -5.820 ± 12.490 | -2.693 ± 8.117 |
| Non-responder (n= 8, 8) | -4.719 ± 11.021 | -7.320 ± 13.950 |
The variable of change from baseline in thickness of the lamina reticularis at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
| micrometer(µm) | Omalizumab | Placebo |
|---|---|---|
| Responder (n= 8, 3) | -1.300 ± 2.926 | -1.603 ± 0.258 |
| Non-responder (n= 8, 8) | 0.098 ± 2.276 | -0.659 ± 2.288 |
| Participants | Omalizumab | Placebo |
|---|---|---|
| At least one adverse event | 19 | 12 |
| At least one serious adverse event | 1 | 0 |
| Death | 0 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omalizumab | — | 1/23 (4.3%) | 16/23 (69.6%) |
| Placebo | — | 0/13 (0%) | 12/13 (92.3%) |
| Event | Omalizumab | Placebo |
|---|---|---|
| Biliary colicHepatobiliary disorders | 1/23 | 0/13 |
| Event | Omalizumab | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/23 | 3/13 |
| SinusitisInfections and infestations | 2/23 | 3/13 |
| HeadacheNervous system disorders | 5/23 | 0/13 |
| NasopharyngitisInfections and infestations | 4/23 | 2/13 |
| NauseaGastrointestinal disorders | 3/23 | 2/13 |
| InfluenzaInfections and infestations | 2/23 | 2/13 |
| Lower respiratory tract infectionInfections and infestations | 3/23 | 2/13 |
| Upper respiratory tract infectionInfections and infestations | 3/23 | 2/13 |
| Back painMusculoskeletal and connective tissue disorders | 2/23 | 2/13 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/23 | 2/13 |
| Age Continuous(Years) | Omalizumab | Placebo | Total |
|---|---|---|---|
| Mean | 43.7 ± 9.66 | 41.8 ± 10.43 | 43.1 ± 9.8 |
| Sex: Female, Male(Participants) | Omalizumab | Placebo | Total |
|---|---|---|---|
| Female | 13 | 6 | 19 |
| Male | 10 | 6 | 16 |
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