Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Double Blind Placebo Controlled Trial of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis

Conditions
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Steroid and/or Prednisone Dependent Asthma, Eosinophilic Bronchitis

Intervention / Treatment
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* Biological: Omalizumab (Xolair)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Confirmed asthma within the past 2 years (12% bronchodilator reversibility or PC20 methacholine less than 8 mg/ml) ACQ ≥1.5 and sputum eos ≥3% at the time of randomization On ICS (≥ 1500 mcg fluticasone propionate or equivalent) with or without additional prednisone Total serum IgE ≥30 IU/L and positive allergy skin prick test Age between 18 and 75 years Ability to provide informed consent Exclusion criteria Current smoker or ex-smokers with greater than 20 pack years Co-morbid diseases which in the investigator's opinion would make the patient unsuitable to participate in the study Currently on Omalizumab or has previously been treated with Omalizumab Currently on other biologic therapies (eg. Prolia) Pregnancy or lactation Post bronchodilator FEV1 less than 50% predicted

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omalizumab (Xolair)<br>Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level. | Drug: Placebo<br> <br> * Other names: 0.9% normal saline;|
| Placebo Comparator: Placebo (Normal Saline)<br>0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab | Biological: Omalizumab (Xolair)<br> <br> * Other names: Anti IgE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eosinophils, Immunoglobin E (IgE), Asthma, Bronchitis, Inflammation, Allergy, Prednisone