COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02049294
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
McMaster University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Steroid and/or Prednisone Dependent Asthma Eosinophilic Bronchitis Biological: Omalizumab (Xolair) Drug: Placebo Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Placebo Controlled Trial of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis
Study Start Date : March 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arm Intervention/treatment
Active Comparator: Omalizumab (Xolair)
Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level.
Drug: Placebo
Other Name: 0.9% normal saline

Placebo Comparator: Placebo (Normal Saline)
0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab
Biological: Omalizumab (Xolair)
Other Name: Anti IgE

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02049294

Layout table for location information
Canada, Alberta
Richard Leigh
Calgary, Alberta, Canada
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Canada, Quebec
University of Laval
Laval, Quebec, Canada
University of Montreal
Montreal, Quebec, Canada
Sponsors and Collaborators
McMaster University
Layout table for investigator information
Principal Investigator: 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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: McMaster University Identifier: NCT02049294    
Other Study ID Numbers: RP 14-008
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by McMaster University:
Immunoglobin E (IgE)
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Antibodies, Monoclonal
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors
Physiological Effects of Drugs