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

Novartis

Status and phase: Terminated; Phase 4

Conditions: Allergic Bronchopulmonary Aspergillosis; Cystic Fibrosis

Treatments: Drug: Itraconazole; Drug: Placebo; Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00787917

CIGE025A2437

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

Omalizumab

Experimental group

Description:

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.

Treatment:

Drug: Omalizumab

Drug: Itraconazole

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Itraconazole