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

McMaster University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Eosinophilic Bronchitis; Steroid and/or Prednisone Dependent Asthma

Treatments: Biological: Omalizumab (Xolair); Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02049294

RP 14-008

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 2 patient groups, including a placebo group

Omalizumab (Xolair)

Active Comparator group

Description:

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

Treatment:

Drug: Placebo

Placebo (Normal Saline)

Placebo Comparator group

Description:

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

Treatment:

Biological: Omalizumab (Xolair)