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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Steroid and/or Prednisone Dependent Asthma Eosinophilic Bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Omalizumab (Xolair)

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (Normal Saline)

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

Group Type PLACEBO_COMPARATOR

Omalizumab (Xolair)

Intervention Type BIOLOGICAL

Interventions

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Omalizumab (Xolair)

Intervention Type BIOLOGICAL

Placebo

Intervention Type DRUG

Other Intervention Names

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Anti IgE 0.9% normal saline

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No