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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by McMaster University
Information provided by (Responsible Party):
Parameswaran Nair, McMaster University Identifier:
First received: January 28, 2014
Last updated: September 12, 2016
Last verified: September 2016

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by McMaster University:

Primary Outcome 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 ] [ Designated as safety issue: No ]
  • Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32. [ Time Frame: From Week 12 to Week 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in % sputum eosinophil [ Time Frame: From Week 0 to Week 32 ] [ Designated as safety issue: No ]
  • Blood eosinophils [ Time Frame: From Week 0 to week 32 ] [ Designated as safety issue: No ]
  • Forced Expired Volume in 1 second (FEV1) [ Time Frame: From Week 0 to Week 32 ] [ Designated as safety issue: No ]
  • Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC) [ Time Frame: From Week 0 to Week 32 ] [ Designated as safety issue: No ]
  • Provocative concentration causing a 20% drop in FEV1 (PC20) [ Time Frame: From Week 0 to Week 32 ] [ Designated as safety issue: No ]
  • Asthma Control Questionnaire [ Time Frame: From Week 0 to Week 32 ] [ Designated as safety issue: No ]
  • Fraction of exhaled nitric oxide (FeNO) [ Time Frame: From Week 0 to Week 32 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2014
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02049294

Contact: Melanie Kjarsgaard 905-522-1155 ext 33024

Canada, Alberta
Richard Leigh Recruiting
Calgary, Alberta, Canada
Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Delbert Dorscheid, MD         
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada
Principal Investigator: Parameswaran Nair, MD, PhD         
Canada, Quebec
University of Laval Recruiting
Laval, Quebec, Canada
Principal Investigator: Louis Phillippe-Boulet, MD         
University of Montreal Recruiting
Montreal, Quebec, Canada
Principal Investigator: Catherine Lemiere, MD         
Sponsors and Collaborators
Parameswaran Nair
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
  More Information

Responsible Party: Parameswaran Nair, Associate Professor of Medicine, McMaster University Identifier: NCT02049294     History of Changes
Other Study ID Numbers: RP 14-008 
Study First Received: January 28, 2014
Last Updated: September 12, 2016
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Immunoglobin E (IgE)

Additional relevant MeSH terms:
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents processed this record on October 21, 2016