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

Primary Purpose

Steroid and/or Prednisone Dependent Asthma, Eosinophilic Bronchitis

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Omalizumab (Xolair)

Placebo

About this trial

This is an interventional treatment trial for Steroid and/or Prednisone Dependent Asthma focused on measuring Prednisone, Eosinophils, Immunoglobin E (IgE), Asthma, Bronchitis, Inflammation, Allergy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Richard Leigh
University of British Columbia
McMaster University
University of Laval
University of Montreal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omalizumab (Xolair)

Placebo (Normal Saline)

Arm Description

Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level.

0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab

Outcomes

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

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

Secondary Outcome Measures

change in % sputum eosinophil

Blood eosinophils

Forced Expired Volume in 1 second (FEV1)

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

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

Asthma Control Questionnaire

Fraction of exhaled nitric oxide (FeNO)

Full Information

NCT ID

NCT02049294

First Posted

January 28, 2014

Last Updated

April 3, 2018

Sponsor

McMaster University

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT02049294

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

Collaborators

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Steroid and/or Prednisone Dependent Asthma, Eosinophilic Bronchitis

Keywords

Prednisone, Eosinophils, Immunoglobin E (IgE), Asthma, Bronchitis, Inflammation, Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omalizumab (Xolair)

Arm Type

Active Comparator

Arm Description

Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level.

Arm Title

Placebo (Normal Saline)

Arm Type

Placebo Comparator

Arm Description

0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab

Intervention Type

Biological

Intervention Name(s)

Omalizumab (Xolair)

Other Intervention Name(s)

Anti IgE

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

0.9% normal saline

Primary Outcome Measure Information:

Title

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

Title

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 Measure Information:

Title

change in % sputum eosinophil

Time Frame

From Week 0 to Week 32

Title

Blood eosinophils

Time Frame

From Week 0 to week 32

Title

Forced Expired Volume in 1 second (FEV1)

Time Frame

From Week 0 to Week 32

Title

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

Time Frame

From Week 0 to Week 32

Title

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

Time Frame

From Week 0 to Week 32

Title

Asthma Control Questionnaire

Time Frame

From Week 0 to Week 32

Title

Fraction of exhaled nitric oxide (FeNO)

Time Frame

From Week 0 to Week 32

Other Pre-specified Outcome Measures:

Title

• 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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: