Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis
Randomized Double Blind Placebo Controlled Trial of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis
1 other identifier
interventional
11
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2014
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2014
CompletedFirst Posted
Study publicly available on registry
January 30, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedApril 4, 2018
January 1, 2018
3.5 years
January 28, 2014
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
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
- +2 more secondary outcomes
Other Outcomes (2)
• Sputum eosinophilopoietic cytokines, chemokines, immunoglobulin levels, expression variation of constitutive immunoglobulin receptors.
From Week 0 to Week 12 and Week 12 to week 32
IgE antagonism and its effect on TSLP with respect to in situ eosinophilopoeisis and local eosinophil activity
From Week 0 to Week 12 and Week 12 to week 32
Study Arms (2)
Omalizumab (Xolair)
ACTIVE COMPARATORDosage/frequency is dependent on body weight (kg) and baseline blood IgE level.
Placebo (Normal Saline)
PLACEBO COMPARATOR0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Novartiscollaborator
Study Sites (5)
Richard Leigh
Calgary, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
McMaster University
Hamilton, Ontario, Canada
University of Laval
Laval, Quebec, Canada
University of Montreal
Montreal, Quebec, Canada
Related Publications (1)
Mukherjee M, Kjarsgaard M, Radford K, Huang C, Leigh R, Dorscheid DR, Lemiere C, Boulet LP, Waserman S, Martin J, Nair P. Omalizumab in patients with severe asthma and persistent sputum eosinophilia. Allergy Asthma Clin Immunol. 2019 Apr 3;15:21. doi: 10.1186/s13223-019-0337-2. eCollection 2019.
PMID: 30988677DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2014
First Posted
January 30, 2014
Study Start
March 1, 2014
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
April 4, 2018
Record last verified: 2018-01