Conditions: Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis
Keywords: Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis omalizumab oral corticosteroid use anti-immunoglobulin E
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 14
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Omalizumab intervention 2: Placebo intervention 3: Itraconazole
Intervention descriptions: intervention 1: Omalizumab subcutaneous injections of 600 mg daily. intervention 2: Placebo subcutaneous injections blinded to match experimental arm dosing regimen. intervention 3: Itraconazole twice daily with a maximum daily dose of 400 mg.

Protocol document: