Dr. Parameswaran Nair
Randomized double blind placebo controlled trial of the prednisone sparing effect of Xolair (Omalizumab/Xolair®) in patients with prednisone-dependent asthma with eosinophilic bronchitis.
Some patients with asthma and eosinophilic bronchitis are dependent on prednisone treatment in order to control their asthma. This study investigates whether the drug Xolair (Omalizumab), an injectable IGE antibody, can help to reduce the dose of prednisone required in some patients. 12 patients will be randomized to Omalizumab treatment and 12 patients will be randomized to placebo treatment. In order to qualify for the study, patients need to be on a prednisone dose of at least 7.5mg daily to keep eosinophils in the sputum <3%.
The study is composed of two parts:
Period 1: After establishing the minimum dose of prednisone to maintain asthma control and maintain sputum eosinophils, 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 will be undertaken until there is a clinical and eosinophilic exacerbation or both, or steroid withdrawal effects. If patients have an exacerbation, they will be treated with prednisone. These patients will continue on Omalizumab or placebo during the entire duration of the study but not continue the phase of steroid reduction.
This study investigates the drug Xolair (Omalizumab) in addition to prednisone in asthma patients who require high doses of prednisone to control their asthma or whose asthma is not well controlled despite prednisone therapy. Xolair might enable the prednisone dose to be reduced in these patients.
For more information about this study please contact study coordinator Melanie Kjarsgaard by e-mail at firstname.lastname@example.org