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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The purpose of this study is to investigate whether addition of Omalizumab enables a reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.
This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial divided into two sequential study periods.
Period 1: After establishing the minimum dose of prednisone to maintain asthma control and maintain sputum eosinophils <3%, subjects will be randomized to either placebo or Omalizumab for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).
Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab or placebo during the entire duration of the study but not continue the phase of steroid reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab (Xolair) | Active Comparator | Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level. |
|
| Placebo (Normal Saline) | Placebo Comparator | 0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab (Xolair) | Biological |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with change in absolute % count of sputum eosinophil week 0 to week 12, and week 12 to week 32 | From Week 0 to Week 12 and Week 12 to week 32 | |
| Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32. | From Week 12 to Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| change in % sputum eosinophil | From Week 0 to Week 32 | |
| Blood eosinophils | From Week 0 to week 32 | |
| Forced Expired Volume in 1 second (FEV1) |
| Measure | Description | Time Frame |
|---|---|---|
| • Sputum eosinophilopoietic cytokines, chemokines, immunoglobulin levels, expression variation of constitutive immunoglobulin receptors. | From Week 0 to Week 12 and Week 12 to week 32 | |
| IgE antagonism and its effect on TSLP with respect to in situ eosinophilopoeisis and local eosinophil activity |
Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Parameswaran Nair, MD, PhD | McMaster University | Principal Investigator |
| Louis-Philippe Boulet, MD | University of Laval | Principal Investigator |
| Catherine Lemiere, MD | Université de Montréal | Principal Investigator |
| Richard Leigh, MB | University of Calgary | Principal Investigator |
| Delbert Dorscheid, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard Leigh | Calgary | Alberta | Canada | |||
| University of British Columbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30988677 | Derived | Mukherjee M, Kjarsgaard M, Radford K, Huang C, Leigh R, Dorscheid DR, Lemiere C, Boulet LP, Waserman S, Martin J, Nair P. Omalizumab in patients with severe asthma and persistent sputum eosinophilia. Allergy Asthma Clin Immunol. 2019 Apr 3;15:21. doi: 10.1186/s13223-019-0337-2. eCollection 2019. |
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| Drug |
|
|
| From Week 0 to Week 32 |
| Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC) | From Week 0 to Week 32 |
| Provocative concentration causing a 20% drop in FEV1 (PC20) | From Week 0 to Week 32 |
| Asthma Control Questionnaire | From Week 0 to Week 32 |
| Fraction of exhaled nitric oxide (FeNO) | From Week 0 to Week 32 |
| From Week 0 to Week 12 and Week 12 to week 32 |
| Vancouver |
| British Columbia |
| Canada |
| McMaster University | Hamilton | Ontario | Canada |
| University of Laval | Laval | Quebec | Canada |
| University of Montreal | Montreal | Quebec | Canada |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001991 | Bronchitis |
| D007249 | Inflammation |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| C026408 | anti-IgE antibodies |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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