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

April 3, 2018 updated by: McMaster University

Randomized Double Blind Placebo Controlled Trial 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Richard Leigh
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster University
    • Quebec
      • Laval, Quebec, Canada
        • University of Laval
      • Montreal, Quebec, Canada
        • University of Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omalizumab (Xolair)
Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level.
Drug: Placebo
Other Names:
  • 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 Names:
  • Anti IgE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
From Week 12 to Week 32

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
• 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
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
Time Frame: From Week 0 to Week 12 and Week 12 to week 32
From Week 0 to Week 12 and Week 12 to week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Novartis

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 14-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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