An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
An Exploratory, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of Multiple Doses of Omalizumab in Cystic Fibrosis Complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)
1 other identifier
interventional
14
5 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2008
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 7, 2008
CompletedFirst Posted
Study publicly available on registry
November 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
August 4, 2011
CompletedSeptember 26, 2011
September 1, 2011
1.7 years
November 7, 2008
July 11, 2011
September 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months of blinded treatment
Secondary Outcomes (5)
Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period
6 months, 12 months
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment
3 months, 6 months
Time to Steroid Free State.
12 months
Change From Baseline in Average Oral Corticosteroid Use.
6 months, 12 months
Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline
6 months, 12 months
Study Arms (2)
Omalizumab
EXPERIMENTALEligible 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
PLACEBO COMPARATOREligible 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
Omalizumab subcutaneous injections of 600 mg daily.
Itraconazole twice daily with a maximum daily dose of 400 mg.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of cancer in the last 10 years.
- History of severe allergic reactions
- Pregnant and lactating women
- Prior use of Xolair
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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
Related Publications (1)
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.
PMID: 26302738DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis
Novartis Investigator Site
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2008
First Posted
November 10, 2008
Study Start
November 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
September 26, 2011
Results First Posted
August 4, 2011
Record last verified: 2011-09