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


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.

Full Title of Study: “Randomized Double Blind Placebo Controlled Trial of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 2017


  • Biological: Omalizumab (Xolair)
  • Drug: Placebo

Arms, Groups and Cohorts

  • Active Comparator: Omalizumab (Xolair)
    • Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level.
  • Placebo Comparator: Placebo (Normal Saline)
    • 0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients with change in absolute % count of sputum eosinophil week 0 to week 12, and week 12 to week 32
    • Time Frame: 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.
    • Time Frame: From Week 12 to Week 32

Secondary Measures

  • change in % sputum eosinophil
    • Time Frame: From Week 0 to Week 32
  • Blood eosinophils
    • Time Frame: From Week 0 to week 32
  • Forced Expired Volume in 1 second (FEV1)
    • Time Frame: From Week 0 to Week 32
  • Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC)
    • Time Frame: From Week 0 to Week 32
  • Provocative concentration causing a 20% drop in FEV1 (PC20)
    • Time Frame: From Week 0 to Week 32
  • Asthma Control Questionnaire
    • Time Frame: From Week 0 to Week 32
  • Fraction of exhaled nitric oxide (FeNO)
    • Time Frame: From Week 0 to Week 32

Participating in This Clinical Trial

Inclusion criteria 1. Confirmed asthma within the past 2 years (12% bronchodilator reversibility or PC20 methacholine less than 8 mg/ml) 2. ACQ ≥1.5 and sputum eos ≥3% at the time of randomization 3. On ICS (≥ 1500 mcg fluticasone propionate or equivalent) with or without additional prednisone 4. Total serum IgE ≥30 IU/L and positive allergy skin prick test 5. Age between 18 and 75 years 6. Ability to provide informed consent Exclusion criteria 1. Current smoker or ex-smokers with greater than 20 pack years 2. Co-morbid diseases which in the investigator's opinion would make the patient unsuitable to participate in the study 3. Currently on Omalizumab or has previously been treated with Omalizumab 4. Currently on other biologic therapies (eg. Prolia) 5. Pregnancy or lactation 6. Post bronchodilator FEV1 less than 50% predicted

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McMaster University
  • Collaborator
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Parameswaran Nair, MD, PhD, Principal Investigator, McMaster University
    • Louis-Philippe Boulet, MD, Principal Investigator, University of Laval
    • Catherine Lemiere, MD, Principal Investigator, Université de Montréal
    • Richard Leigh, MB, Principal Investigator, University of Calgary
    • Delbert Dorscheid, MD, Principal Investigator, University of British Columbia

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