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

• Status: Terminated
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Hydroxyitraconazole; Itraconazole; Omalizumab

Criteria

Inclusion Criteria:

• Diagnosis of Cystic Fibrosis complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)

• Oral corticosteroid use for ABPA flare

• Age 12 years and older (except for Italy; ≥ 18 years)

• Total serum IgE levels ≥ 500 IU/mL

Exclusion Criteria:

• History of cancer in the last 10 years.

• History of severe allergic reactions

• Pregnant and lactating women

• Prior use of Xolair

Other protocol-defined inclusion/exclusion criteria may apply.