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

Phase 4TerminatedNCT00787917

Novartis Pharmaceuticals14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis

Interventions

OmalizumabDRUG

Omalizumab subcutaneous injections of 600 mg daily.

PlaceboDRUG

Placebo subcutaneous injections blinded to match experimental arm dosing regimen.

ItraconazoleDRUG

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

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (10)

Novartis Investigator Site

Leuven, Belgium

Novartis Investigator Site

Berlin, Germany

Novartis Investigator Site

Bonn, Germany

Novartis Investigator Site

Munich, Germany

Outcomes

Primary Outcomes

Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen

Time frame: 6 months of blinded treatment

Secondary Outcomes

Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period

Time frame: 6 months, 12 months

Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment

Time frame: 3 months, 6 months

Time to Steroid Free State.

Time frame: 12 months

Change From Baseline in Average Oral Corticosteroid Use.

Time frame: 6 months, 12 months

Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline

Time frame: 6 months, 12 months

Data from ClinicalTrials.gov

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