An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
Cystic Fibrosis, Allergic Bronchopulmonary Aspergillosis
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Allergic Bronchopulmonary Aspergillosis, omalizumab, oral corticosteroid use, anti-immunoglobulin E
Eligibility 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.
Sites / Locations
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Omalizumab
Placebo
Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg. Participants who completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.
Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.