NCT02049294

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

Randomized Double Blind Placebo Controlled Trial of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Steroid and/or Prednisone Dependent Asthma
• Eosinophilic Bronchitis

Interventions

Type	Name	Description
BIOLOGICAL	Omalizumab (Xolair)
DRUG	Placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2014-01-30
• Last updated: 2018-04-04

Locations

5 sites across 1 country: Canada