An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
NCT ID: NCT00787917
Last Updated: 2011-09-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
14 participants
INTERVENTIONAL
2008-11-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Omalizumab
Omalizumab subcutaneous injections of 600 mg daily.
Itraconazole
Itraconazole twice daily with a maximum daily dose of 400 mg.
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.
Placebo
Placebo subcutaneous injections blinded to match experimental arm dosing regimen.
Itraconazole
Itraconazole twice daily with a maximum daily dose of 400 mg.
Interventions
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Omalizumab
Omalizumab subcutaneous injections of 600 mg daily.
Placebo
Placebo subcutaneous injections blinded to match experimental arm dosing regimen.
Itraconazole
Itraconazole twice daily with a maximum daily dose of 400 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 severe allergic reactions
* Pregnant and lactating women
* Prior use of Xolair
12 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis
Role: PRINCIPAL_INVESTIGATOR
Novartis Investigator Site
Locations
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Novartis Investigator Site
Leuven, , Belgium
Novartis Investigator Site
Berlin, , Germany
Novartis Investigator Site
Bonn, , Germany
Novartis Investigator Site
Munich, , Germany
Novartis Investigator Site
Milan, , Italy
Novartis Investigator Site
Rome, , Italy
Novartis Investigator Site
Nijmegen, , Netherlands
Novartis Investigator Site
Utrecht, , Netherlands
Novartis Investigator Site
Cambridge, , United Kingdom
Novartis Investigator Site
London, , United Kingdom
Countries
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References
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Beam KT, Coop CA. Steroid sparing effect of omalizumab in seropositive allergic bronchopulmonary aspergillosis. Allergy Rhinol (Providence). 2015 Jan;6(2):143-5. doi: 10.2500/ar.2015.6.0128.
Other Identifiers
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CIGE025A2437
Identifier Type: -
Identifier Source: org_study_id