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

Conditions

• Eosinophilic Bronchitis
• Steroid and/or Prednisone Dependent Asthma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Omalizumab (Xolair) — BIOLOGICAL
• Placebo — DRUG

Study Details

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.

Key Dates

Start date

Mar 31, 2014

Status verified

Jan 2018

Primary completion

Sep 30, 2017

Completion

Sep 30, 2017

Study Design

Enrollment

11 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Omalizumab (Xolair)
  Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level.
• Placebo Comparator: Placebo (Normal Saline)
  0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab

Primary Outcome Measure

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 ]