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NCT Number: NCT02049294

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.

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Key information

Conditions

Steroid and/or Prednisone Dependent Asthma Asthma Bronchial Diseases Bronchitis Eosinophilic Bronchitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Richard Leigh, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omalizumab (Xolair)

Biological

Other names: Anti IgE

Placebo

Drug

Other names: 0.9% normal saline

Primary outcomes

  1. 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

  2. Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32.

    Time frame: From Week 12 to Week 32

Secondary outcomes

  1. change in % sputum eosinophil

    Time frame: From Week 0 to Week 32

  2. Blood eosinophils

    Time frame: From Week 0 to week 32

  3. Forced Expired Volume in 1 second (FEV1)

    Time frame: From Week 0 to Week 32

  4. Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC)

    Time frame: From Week 0 to Week 32

  5. Provocative concentration causing a 20% drop in FEV1 (PC20)

    Time frame: From Week 0 to Week 32

  6. Asthma Control Questionnaire

    Time frame: From Week 0 to Week 32

  7. Fraction of exhaled nitric oxide (FeNO)

    Time frame: From Week 0 to Week 32

Other outcomes

  1. • Sputum eosinophilopoietic cytokines, chemokines, immunoglobulin levels, expression variation of constitutive immunoglobulin receptors.

    Time frame: From Week 0 to Week 12 and Week 12 to week 32

  2. IgE antagonism and its effect on TSLP with respect to in situ eosinophilopoeisis and local eosinophil activity

    Time frame: From Week 0 to Week 12 and Week 12 to week 32

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2014
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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