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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT00787917
Phase
PHASE4
Status
Terminated

Conditions

  • Allergic Bronchopulmonary Aspergillosis
  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    Omalizumab subcutaneous injections of 600 mg daily.
  • Placebo — DRUG
    Placebo subcutaneous injections blinded to match experimental arm dosing regimen.
  • Itraconazole — DRUG
    Itraconazole twice daily with a maximum daily dose of 400 mg.

Study Details

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.

Key Dates

Start date
Nov 30, 2008
Status verified
Sep 2011
Primary completion
Jul 31, 2010
Completion
Jul 31, 2010

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

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 ]

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