Eosinophilic Bronchitis Clinical Trial
Official title:
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.
n/a
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