drugset / Trial / NCT00787917

An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)

NCT00787917

Phase 4 Terminated 14 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and older.

Timeline

Start
2008-11
Primary completion
2010-07
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody 600 mg Subcutaneous
Background Itraconazole Small molecule 400 mg