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

PHASE4TerminatedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Cystic FibrosisAllergic Bronchopulmonary Aspergillosis
Interventions
DRUG

Omalizumab

Omalizumab subcutaneous injections of 600 mg daily.

DRUG

Placebo

Placebo subcutaneous injections blinded to match experimental arm dosing regimen.

DRUG

Itraconazole

Itraconazole twice daily with a maximum daily dose of 400 mg.

Trial Locations (10)

Unknown

Novartis Investigator Site, Leuven

Novartis Investigator Site, Berlin

Novartis Investigator Site, Bonn

Novartis Investigator Site, Munich

Novartis Investigator Site, Milan

Novartis Investigator Site, Rome

Novartis Investigator Site, Nijmegen

Novartis Investigator Site, Utrecht

Novartis Investigator Site, Cambridge

Novartis Investigator Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY